hazelo lab pvt. ltd. lab pvt. ltd., yadadri... · hazelo lab pvt. ltd. team labs and consultants...

HAZELO LAB PVT. LTD. SY.NO. 240, 242, 243, 247, 248 AND 249, DOTHIGUDEM VILLAGE, POCHAMPALLY MANDAL, YADRADI BHUVANAGIRI DISTRICT,

TELANGANA

DRAFT EIA REPORT

1. ENVIRONMENTAL IMPACT ASSESSMENT 2. ENVIRONMENT MANAGEMENT PLAN 3. COMPLIANCE OF TERMS OF REFERENCE 4. ANNEXURES

Project No. 0317‐21‐01March 2017

Hazelo Lab Pvt. Ltd. Hetero Corporate Office, 7‐2‐A2, Industrial Estate Sanath Nagar, Hyderabad, Telanagana – 500 018 Phone: 08455‐233585 Fax: 08455‐233840 E‐mail: [email protected]

STUDIES AND DOCUMENTATION BYTEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD,

REGIONAL OFFICE, NALGONDA

HAZELO LAB PVT. LTD. SY.NO. 240, 242, 243, 247, 248 AND 249, DOTHIGUDEM VILLAGE, POCHAMPALLY MANDAL, YADRADI BHUVANAGIRI DISTRICT,

TELANGANA

1. ENVIRONMENTAL IMPACT ASSESSMENT REPORT

Project No. 0317‐21‐01March 2017

Hazelo Lab Pvt. Ltd. Hetero Corporate Office, 7‐2‐A2, Industrial Estate Sanath Nagar, Hyderabad, Telanagana – 500 018 Phone: 08455‐233585 Fax: 08455‐233840 E‐mail: [email protected]

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD,

REGIONAL OFFICE, NALGONDA

Hazelo Lab Pvt. Ltd.

Team Labs and consultants

Declaration by Experts Contributing to the EIA

I, hereby, certify that I was a part of the EIA team in the following capacity that developed the above EIA.

EIA coordinator:

Name: G.V. Reddy

Signature and Date: November 9, 2016

Period of involvement: October 2015 to till date

Contact information: Team Labs and Consultants, B115 - 117, 509, Aditya Enclave, Ameerpet, Hyderabad 500038.

Functional area experts:

S. No.

Functional areas

Name of the expert/s

Involvement (period and task**)

Period of involvement : Feb xxx till date

Signature and date

March 15, 2017

1 AP T.Ravi kiran Site visit, Design of AAQ network, supervision of AAQ monitoring, Compilation of emissions and characteristics, assessment of impacts due to the proposed expansion, identification of mitigation measures, preparation of EMP for AP, Preparation of monitoring plan for AP.

2 WP G.V.Reddy Site visit, identification of monitoring stations, supervision of sampling, Characterization of effluent streams, segregation of effluent streams, ZLD for effluent treatment, assessment of impacts due to the proposed expansion, identification of mitigation measures, preparation of EMP for WP, Preparation of monitoring plan for WP.

3 SHW G.V.Reddy Site visit, Characterization of solid wastes, storage, and disposal plan for various solid wastes, assessment of impacts due to the proposed expansion, identification of mitigation measures, preparation of EMP for SHW.

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Declaration by the Head of the accredited consultant organization/ authorized person

I, G.V. Reddy hereby, confirm that the above mentioned experts prepared the EIA report for M/s. Hazelo Lab Pvt. Ltd. I also confirm that the consultant organization shall be fully accountable for any mis-leading information mentioned in this statement.

Signature:

Name: G.V. Reddy Designation: Director Name of the EIA consultant organization: Team Labs And Consultants NABET Certificate No: S. No. 148 of List ‘A’ – Accredited EIA Consultant Organizations complying with Version 3 of the Scheme - as on Rev. 51 March 07, 2017

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Hazelo Lab Pvt. Ltd., Contents

CONTENTS

Section Description Page No.

Declaration by Experts Contributing to the EIA

E.0 Executive Summary 1-1

1.0 Introduction of The Project 1-1 1.1 Product Profile 1-3 1.2 Technology 1-5 1.3 Plant Location & Layout 1-5 1.4 Scope of EIA Studies 1-8

2 Process Description and Pollution control Facilities 2-1 2.1 Process Description 2-3

2.1.1 Process Description of Amlodipine Besylate 2-3 2.1.2 Process Description of Bupropion HCl 2-5 2.1.3 Process Description of Clopidogrel Hydrogen Sulfate 2-8 2.1.4 Process Description of Desvelofloxin Succinate 2-11 2.1.5 Process Description of Divolproex Sodium 2-14 2.1.6 Process Description of Dulaxetine HCl 2-16 2.1.7 Process Description of Esomeprazole Mg Dihydrate 2-18 2.1.8 Process Description of Glimepiride 2-20 2.1.9 Process Description of Mesalamine 2-22

2.1.10 Process Description of Metaprolol Succinate 2-23 2.1.11 Process Description of Pantoprazole Sodium Sesquihydrate 2-27 2.1.12 Process Description of Pragabalin 2-29 2.1.13 Process Description of Rosuvastatin Calcium 2-30 2.1.14 Process Description of Sertraline HCl 2-33 2.1.15 Process Description of Tramadal 2-35 2.1.16 Process Description of Valcyclovir Hydrochloride Monohydrate 2-37 2.1.17 Process Description of 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid

methyl ester 2-41

2.1.18 Process Description of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine

2-47

2.1.19 Process Description of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol

2-50

2.1.20 Process Description of 2,8-Diazo bicyclo Nonane 2-55 2.1.21 Process Description of 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 2-61 2.1.22 Process Description of 2- Acetyl Ethoxy acetyl methoxy ether 2-63 2.1.23 Process Description of N,N-Carbonyl di imidazole 2-64 2.1.24 Process Description of (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl

Amino 1,6-diohenyl 2-65

2.1.25 Process Description of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid 2-70 2.1.26 Process Description of Guanine 2-73


2.1.27 Process Description of Poly allyl amine HCl 2-74 2.1.28 Process Description of Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-

isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate

2-75

2.1.29 Process Description of 5-Cyano phthalide 2-80 2.1.30 Process Description of 1,1-Cyclohexanediacetic acid 2-83 2.1.31 Process Description of Carbamyl Methyl-5-Methyl hexanoic Acid 2-85 2.1.32 Process Description of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 2-87 2.1.33 Process Description of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine

amine 2-91

2.1.34 Process Description of 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid dihydrochloride

2-94

2.1.35 Process Description of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide

2-96

2.2 Utilities 2-100 2.3 Water Requirement 2-100 2.4 Pollution Control Facilities 2-101

2.4.1 Water Pollution 2-101 2.4.1.1 Process Description and Technical Specification of Effluent Treatment System 2-109

2.4.2 Air Pollution 2-116 2.4.2.1 Emissions from Utilities 2-116 2.4.2.2 Emissions from Process 2-118 2.4.2.3 Diffuse Emissions 2-121 2.4.2.4 Fugitive Emissions 2-121 2.4.2.5 Solvent Use and Recycle 2-121

2.4.3 Solid Waste 2-130 2.4.4 Noise Pollution 2-139

3.0 Baseline Environmental Status 3-1 3.1 Introduction 3-1 3.2 Land Environment 3-1

3.2.1 Physiography 3-1 3.2.2 Geology 3-3 3.2.3 Hydrogeology 3-3 3.2.4 Soils 3-4

3.3 Water environment 3-11 3.3.1 Surface Water Resources 3-11

3.3.1.1 Surface water Quality 3-11 3.3.2 Ground Water resources 3-13

3.3.2.1 Quality Of Ground Water 3-13 3.4 Air environment 3-19

3.4.1 Meteorology 3-19 3.4.2 Meteorological Station at Plant Site 3-22 3.4.3 Ambient air quality 3-25 3.4.4 Scope of field study 3-25 3.4.5 Description of sampling locations 3-27 3.4.6 Ambient Air Quality Status 3-29


3.5 Noise environment 3-30 3.6 Socio economic environment 3-33

3.6.1 Demography 3-33 3.6.1.1 Population Distribution 3-33 3.6.1.2 Literacy 3-34 3.6.1.3 Employment/Occupation 3-35

3.6.2 Living standards and Infrastructure 3-36 3.6.3 Land Utilization 3-38 3.6.4 Project Economy 3-39

3.7 Flora and Fauna 3-39 3.7.1 Land use and land cover of the study area 3-39 3.7.2 Land use and land cover of the plant site 3-40 3.7.3 Terrestrial Vegetation and Flora in the study area 3-40 3.7.4 Terrestrial Fauna 3-46 3.7.5 Aquatic Flora and Fauna 3-48

4 Identification of Impacts 4.1 Identification of Impacts 4-1 4.2 Impact Networks 4-1

4.2.1 Air Environment 4-1 4.2.2 Water Environment 4-2 4.2.3 Noise Environment 4-2 4.2.4 Land Environment 4-3 4.2.5 Biological Environment 4-3 4.2.6 Socio-Economic Environment 4-3

4.3 Prediction of Impact on Air Quality 4-10 4.3.1 Details of Mathematical Modeling 4-10

4.3.1.1 Model Formulation 4-11 4.3.1.2 Meteorological Data 4-12

4.3.2 Plant Emissions 4-13 4.3.2.1 Diffuse Emissions 4-16 4.3.2.2 Fugitive Emissions 4-16 4.3.2.3 Air Quality Predictions 4-16 4.3.2.4 Prediction of Concentration of Solvents in the Indoor Environment Due to

Solvent Loss and Fugitive Emissions 4-25

4.4 Prediction of Impact on Noise quality 4-26 4.5 Prediction of Impact on water quality 4-27 4.6 Prediction of Impact on soil 4-28 4.7 Prediction of Impact on Socio Economics 4-28 4.8 Impacts of the Industry on Flora and Fauna 4-28 4.9 Prediction of Impact on Vehicular Traffic 4-29

5 Environmental Monitoring 5-1 5.1.1 Introduction 5-1 5.1.2 Objectives 5-1 5.1.3 Methodology 5-1 5.1.4 Ambient Air Quality (AAQ) Monitoring 5-2 5.1.5 Water Quality Monitoring 5-3 5.1.6 Noise Level Monitoring 5-8 5.1.7 Responsibility of Monitoring and Reporting System 5-9

5.1.7.1 Work Zone Monitoring for Hazardous Chemicals 5-10


5.2 Environmental Monitoring Budget 5-10

6 Risk Assessment and Damage Control 6-1 6.0 Introduction 6-1 6.1 Objectives and Scope 6-1 6.2 Project Details 6-2 6.3 Process Description 6-10 6.4 Plant Facilities 6-10

6.4.1 Production Blocks 6-10 6.4.2 Utilities 6-10 6.4.3 Quality Control, R&D Lab 6-11 6.4.4 ETP and Solid Waste storage 6-11 6.4.5 Ware Houses 6-11 6.4.6 Tank Farm Area 6-12 6.4.7 Cylinders Storage Area 6-12 6.4.8 Administrative Office 6-12 6.4.9 Water Sump 6-12

6.4.10 House Keeping 6-12 6.4.11 Facility Layout and Design 6-12

6.5 Hazard Analysis and Risk Assessment 6-14 6.5.1 Introduction 6-14 6.5.2 Hazard Identification 6-14 6.5.3 Fire & Explosion Index (F & EI) 6-18

6.5.3.1 Methodology 6-18 6.5.4 Hazard and Operability Study (HAZOP) 6-20 6.5.5 Hazard Factors 6-21 6.5.6 Common Causes of Accidents 6-24

6.6 Maximum Credible Accident and Consequence Analysis (MCACA) 6-26 6.6.1 Methodology 6-26 6.6.2 Identification of Vulnerable Areas 6-27 6.6.3 Representative Accident Scenarios 6-27

6.7 Consequence Analysis 6-28 6.7.1 Release Models and Source strength 6-29 6.7.2 Results of Consequence Analysis 6-31

6.7.2.1 Analysis of Hazardous Scenarios 6-32 6.7.2.1.1 Heat radiation effects 6-32 6.7.2.1.2 Toxic Dispersion 6-37 6.7.2.1.3 Overpressure effects 6-40

6.7.3 Observations 6-40 6.7.4 Recommendations 6-40 6.7.5 Toxic management plan 6-41 6.7.6 Transportation 6-43 6.7.7 Control measures for accidental spillage of chemicals 6-45

6.8 Disaster Management Plan 6-47 6.8.1 Introduction 6-47 6.8.2 Objectives Of Emergency Management Plan (On-Site) 6-48 6.8.3 Scope Of ONSEP 6-49 6.8.4 Methodology Of Developing ONSET 6-49 6.8.5 Element Of ONSITE Emergency Plane 6-49

6.8.5.1 Emergencies Identified 6-50


6.8.5.2 Emergency Organization 6-50 6.8.5.3 Emergency Facilities 6-50 6.8.5.4 Emergency Procedures 6-53 6.8.5.5 Rescue and Rehabilitation 6-54 6.8.5.6 Emergency Responsibilities 6-55

6.8.6 Remedial Action 6-60 6.8.7 Basic Action In Emergencies 6-61 6.8.8 Fire Fighting Operations 6-61


List of Tables S.No Description Page. No.

1.1 Manufacturing Capacity 1-3 2.1 Manufacturing Capacity Permitted 2-1 2.2 Manufacturing Capacity after Expansion 2-1 2.3 List of By-Product after Expansion 2-2 2.4 Material Balance of Amlodipine Besylate 2-4 2.5 Material Balance of Bupropion HCl 2-7 2.6 Material Balance of Clopidogrel Hydrogen Sulfate 2-10 2.7 Material Balance of Desvelofloxin Succinate 2-13 2.8 Material Balance of Divolproex Sodium 2-15 2.9 Material Balance of Dulaxetine HCl 2-17

2.10 Material Balance of Esomeprazole Mg Dihydrate 2-19 2.11 Material Balance of Glimepiride 2-21 2.12 Material Balance of Mesalamine 2-23 2.13 Material Balance of Metaprolol Succinate 2-26 2.14 Material Balance of Pantoprazole Sodium Sesquihydrate 2-28 2.15 Material Balance of Pragabalin 2-30 2.16 Material Balance of Rosuvastatin Calcium 2-32 2.17 Material Balance of Sertraline HCl 2-34 2.18 Material Balance of Tramadal 2-36 2.19 Material Balance of Valcyclovir Hydrochloride Monohydrate 2-39

2.20 Material Balance of 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid methyl ester

2-45

2.21 Material Balance of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine

2-49

2.22 Material Balance of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol

2-53

2.23 Material Balance of 2,8-Diazo bicyclo Nonane 2-59 2.24 Material Balance of 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 2-62 2.25 Material Balance of 2- Acetyl Ethoxy acetyl methoxy ether 2-63 2.26 Material Balance of N,N-Carbonyl di imidazole 2-64 2.27 Material Balance of (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino

1,6-diohenyl 2-68

2.28 Material Balance of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid 2-72 2.29 Material Balance of Guanine 2-73 2.30 Material Balance of Poly allyl amine HCl 2-74 2.31 Material Balance of Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-

2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate

2-78

2.32 Material Balance of 5-Cyano phthalide 2-82 2.33 Material Balance of 1,1-Cyclohexanediacetic acid 2-84 2.34 Material Balance of Carbamyl Methyl-5-Methyl hexanoic Acid 2-86 2.35 Material Balance of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 2-89 2.36 Material Balance of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine

amine 2-93

2.37 Material Balance of 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid 2-95


dihydrochloride 2.38 Material Balance of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl]

propanamide 2-98 2.39 List of Utilities 2-100 2.40 Total Water balance 2-100 2.41 Total Effluents generated and Mode of Treatment 2-101 2.42 Quantity and Characteristics of Process Effluents – Product Wise 2-102 2.43 Quantity and Characteristics of Process Effluents – Stage Wise 2-104 2.44 Details of Treatment Facilities 2-110 2.45 Technical Specifications of Effluent Treatment System 2-112 2.46 Technical Specifications of Biological Treatment Plant 2-113 2.47 Emission Details of Pollutants from Stack 2-116 2.48 Technical Specifications of Bag Filters 2-117 2.49 Quantity and Mode of Treatment of Process Emissions 2-118 2.50 Technical Specifications of Two Stage Scrubber 2-120 2.51 Total Solvent Balance – Product Wise 2-122 2.52 Total Solvent Balance – Stage Wise 2-124 2.53 Solid Wastes Generated from Process – Product Wise 2-131 2.54 Solid Waste Generated from Process – Stage Wise 2-133 2.55 Total Solid Waste Generated and Mode of Disposal 2-140

3.1 Soil Analysis Data 3-9 3.2 Soil Test Results – Reference Tables 3-10 3.3 Surface water Analysis 3-12 3.4 Locations of Ground water Sampling 3-13 3.5 Water Analysis Data 3-17 3.6 Meteorological data at IMD Station 3-20 3.7 Frequency Distribution of Wind Speeds and Wind Directions 3-23 3.8 National Ambient Air Quality Standards 3-26 3.9 Locations of Ambient Air Quality Monitoring Stations 3-27

3.10 Summary Ambient Air Quality Status 3-29 3.11 Effects on Human Beings at Different Noise Levels 3-31 3.12 Equivalent Noise levels in the Study Area 3-31 3.13 Population Distribution – Study Area 3-34 3.14 Literacy - Study Area 3-34 3.15 Employment - Study Area 3-35 3.16 Main workers study area 3-36 3.17 Land utilization Pattern 3-38 3.18 List of trees and shrubs found in the study area 3-41 3.19 Comparative list of the Weed flora in the study area 3-43 3.20 Check list of non woody plant species found in the buffer area 3-46 3.21 List of aquatic/semi aquatic macrophytes found in the study area 3-48 3.22 List of fishes either caught by the fisherman or reported from the study 3-49 4.1 Salient Features of the ISCST3 Model 4-11 4.2 Emission Details of Pollutants from Stack 4-14 4.3 Maximum Predicted 24 hourly GLC’s 4-17 4.4 Predicted GLC’s at Monitoring Locations 4-18 4.5 Cumulative Concentrations at Various Villages 4-19 4.6 Solvent Loss and the Predicted Airborne Concentrations 4-26 5.1 National Ambient Air Quality Standards 5-2


5.2 Indian Standard Drinking Water Specification-IS:10500:1991 5-4 5.3 Noise Level Standards (CPCB) 5-8 5.4 Environmental Monitoring Plan 5-8 5.5 Environmental Monitoring Budget 5-10 6.1 Proposed Manufacturing Capacity 6-3 6.2 List of By-Products – After Expansion 6-4 6.3 List of Raw Materials and Inventory 6-5 6.4 List of Utilities 6-11 6.5 Applicability of GOI Rules to Storage/Pipeline 6-16 6.6 Physical Properties of Raw Materials and Solvents 6-17 6.7 Degree of Hazard for F&EI 6-19 6.8 Fire & Explosion Index for Tank farm 6-19 6.9 Failure Rate Data 6-25

6.10 Ignition Sources of Major Fires 6-25 6.11 General Failure Frequencies 6-28 6.12 Damage Due to Incident Radiation Intensities 6-30 6.13 Radiation Exposure and Lethality 6-31 6.14 Damage Due to Peak Over Pressure 6-31 6.15 Heat Radiation Damage Distances – Tank Farm 6-32 6.16 Heat Radiation Damage Distances – Hydrogen Cylinders 6-37 6.17 Toxic Dispersion Damage Distance 6-38 6.18 List of Toxic/Carcinogenic chemicals and mode of Storage/Transport 6-41 6.19 Truck Incidents – Initiating and Contributing Causes 6-44 6.20 Transportation specific concerns 6-44 6.21 List of Fire Extinguishers 6-52


List of Figures S.No Description Page. No.

1.1 Location of Location of M/s. Hazelo Lab Pvt. Ltd., 1-6 1.2 Plant Layout of Location of M/s. Hazelo Lab Pvt. Ltd., 1-7 2.1 Process Flow diagram of Amlodipine Besylate 2-3 2.2 Process Flow diagram of Bupropion HCl 2-6 2.3 Process Flow diagram of Clopidogrel Hydrogen Sulfate 2-9 2.4 Process Flow diagram of Desvelofloxin Succinate 2-12 2.5 Process Flow diagram of Divolproex Sodium 2-14 2.6 Process Flow diagram of Dulaxetine HCl 2-16 2.7 Process Flow diagram of Esomeprazole Mg Dihydrate 2-18 2.8 Process Flow diagram of Glimepiride 2-20 2.9 Process Flow diagram of Mesalamine 2-22

2.10 Process Flow diagram of Metaprolol Succinate 2-25 2.11 Process Flow diagram of Pantoprazole Sodium Sesquihydrate 2-27 2.12 Process Flow diagram of Pragabalin 2-29 2.13 Process Flow diagram of Rosuvastatin Calcium 2-31 2.14 Process Flow diagram of Sertraline HCl 2-33 2.15 Process Flow diagram of Tramadal 2-35 2.16 Process Flow diagram of Valcyclovir Hydrochloride Monohydrate 2-38 2.17

Process Flow diagram of 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid methyl ester

2-43

2.18

Process Flow diagram of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine

2-48

2.19

Process Flow diagram of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol 2-51

2.20 Process Flow diagram of 2,8-Diazo bicyclo Nonane 2-57 2.21

Process Flow diagram of 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 2-61

2.22 Process Flow diagram of 2- Acetyl Ethoxy acetyl methoxy ether 2-63 2.23 Process Flow diagram of N,N-Carbonyl di imidazole 2-64 2.24

Process Flow diagram of (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-diohenyl

2-67

2.25

Process Flow diagram of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid

2-71

2.26 Process Flow diagram of Guanine 2-73 2.27 Process Flow diagram of Poly allyl amine HCl 2-74 2.28

Process Flow diagram of T ert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate

2-76

2.29 Process Flow diagram of 5-Cyano phthalide 2-81 2.30 Process Flow diagram of 1,1-Cyclohexanediacetic acid 2-83 2.31 Process Flow diagram of Carbamyl Methyl-5-Methyl hexanoic Acid 2-85 2.32 Process Flow diagram of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 2-88 2.33

Process Flow diagram of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine

2-92

2.34

Process Flow diagram of 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid dihydrochloride

2-94

2.35 Process Flow diagram of 2, 3-Epoxy-2-methyl-N-[4-cyano-3- 2-97


(trifluoromethyl) phenyl] propanamide 2.36 Schematic Diagram of Effluent Treatment System 2-111 2.37 Schematic Diagram of Scrubbing System 2-120 2.38 Schematic Diagram of Solvent Recovery system 2-129

3.1 Hazelo Lab Pvt. Ltd- Site Photographs 3-2 3.2 Base map of the study area 3-6 3.3 Land use and land cover map of the study area 3-7 3.4 Soil Sampling Locations 3-8 3.5 Drainage Pattern of the Study area 3-14 3.6 Digital Elevation Model map the study area 3-15 3.7 Water Sampling Locations 3-16 3.8 Wind Rose Diagram at Plant Site 3-24 3.9 Ambient Air Quality Monitoring Locations 3-28

3.10 Noise Sampling Locations 3-32 4.1 Impacts Network For Air Environment 4-4 4.2 Impacts Network For Noise Environment 4-5 4.3 Identification of Likely Impacts For Waste Water 4-6 4.4 Impacts Network For Land Environment 4-7 4.5 Impacts Network For Soil Micro Flora Fauna 4-8 4.6 Impact Network For Socio-Economic And Cultural Environment 4-9 4.7 Isopleths Showing 24 Hourly GLC’s of SPM 4-20 4.8 Isopleths Showing 24 Hourly GLC’s of PM10 4-21 4.9 Isopleths Showing 24 Hourly GLC’s of PM2.5 4-22

4.10 Isopleths Showing 24 Hourly GLC’s of SO2 4-23 4.11 Isopleths Showing 24 Hourly GLC’s of NOX 4-24

6.1 Plant Layout of Hazelo Lab Pvt. Ltd. 6-13 6.2 Steps in Consequence Calculations 6-30 6.3 Heat Radiation Damage -30K1 Dichloro Methane Tank 6-34 6.4 Heat Radiation Damage -30K1 Toluene Tank 6-35 6.5 Heat Radiation Damage - 30Kl n-Hexane Tank 6-36 6.6 Toxic Dispersion of Ammonia Cylinder 6-39 6.7 Toxic Dispersion of 1Ton HCl Cylinder 6-39

Hazelo Lab Pvt. Ltd. Executive Summary

Team Labs and consultants E-1

EXECUTIVE SUMMARY

Introduction

Pharmaceutical Chemicals are used for the benefit of human and animal health. The scale

of manufacturing of active pharma ingredients is less compared to other synthetic

organic chemicals, which are used for the manufacture of consumer products, dyes etc.

India is a major producer of active pharma ingredients contributing to wellbeing of both

human and animal population of the world.

M/s. Hazelo Lab Pvt. Ltd (Formerly known as Venlar Labs (P) Ltd.) obtained consent for

operation vide letter no. TSPCB/RCP/NLG/16644/HO/2015-986 dt. 14.08.2015 for

manufacturing bulk Drug Intermediates at Sy.Nos. 240, 242, 243, 247, 248 and 249,

Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri district, Telangana. It is

proposed to expand the manufacturing capacity to 14.2 TPD by acquiring additional

land area of 29.16 acres with a capital cost of Rs. 45 Crores. Total land area after

expansion is 33.485 acres and the expansion mainly involves construction and

commissioning of additional production blocks, utilities and Zero Liquid Discharge

facility. Prior environmental clearance has to be obtained from Ministry of Environment,

Forest and climate change, vide SO 1533, dated September 14, 2006, for synthetic organic

chemicals manufacturing activity. The terms of reference for the environmental impact

assessment studies was obtained from MoEF&CC vide letter no. F.No. J-11011/19/2016-

IA II (I) dated 31.03.2016 as part of environmental clearance process.

Location of the Project:

The project site is located at Survey Number 240, 242, 243, 247, 248 and 249, Dothigudem

Village, Pochampally Mandal, Yadadri Bhuvanangiri District, Telangana. The site is

located at the intersection of 170 17’ 17” (N) latitude and 780 50’ 46” (E) longitude. The site

elevation above mean sea level (MSL) is 407 m. The site is surrounded by open land in

north, west and south directions and SVR Laboratries Pvt. Ltd., in east direction. The

nearest habitation form the site is Antammagudem located at a distance of 0.65 km in

east direction. The main approach road is Dothigudem – NH9 connecting road in west

direction. National Highway-9 is at a Distance of 2.8 Km in Southwest Direction to the

site. The nearest Town is Choutuppal at a distance of 5.6 km in southeast direction and



nearest airport is Shamshabad located at a distance of 44 km in southwest direction.

Chinna Musi River is passing from NW to NE at a Distance of 5.8 Km in NW direction to

the site. There are seven reserve forests in the study area; Lakkaram RF at a distance of

1.2 km in south direction, Chauttuppal RF at a distance of 4.8 km in northwest direction,

Malkapuram RF at a distance of 2.2 km in west direction, Hafeezpura RF at a distance of

7 km in southwest direction, Ailaupur RF at a distance of 6.7 km in southwest direction,

Meharnagar RF at a distance of 5.3 km in northwest direction and Jalalpur RF at a

distance of 6.7 km in northwest direction are in the impact area. There is no National

Park, Wildlife sanctuary, ecologically sensitive area, critically polluted area and interstate

boundary within the impact area of 10 km surrounding the site.

Product Profile

The manufacturing capacity of proposed products after expansion is presented in the

following table

Manufacturing Capacity – After Expansion S.No Name of Product CAS No. Capacity

(TPD) 1 Amlodipine Besylate 88150-42-9 0.33 2 Bupropion HCl 34841-39-9 0.83 3 Clopidogrel Hydrogen Sulfate 113665-84-2 0.33 4 Desvelofloxin Succinate 386750-22-7 0.17 5 Divolproex Sodium 76584-70-8 0.57 6 Dulaxetine HCl 136434-34-9 0.17 7 Esomeprazole Mg Dihydrate 217087-09-7 0.33 8 Glimepiride 93479-97-1 0.17 9 Mesalamine 89-57-6 0.17 10 Metaprolol Succinate 37350-58-6 0.50 11 Pantoprazole Sodium Sesquihydrate 138786-67-1 0.50 12 Pragabalin 148553-50-8 0.50 13 Rosuvastatin Calcium 287714-41-4 0.10 14 Sertraline HCl 79559-97-0 0.33 15 Tramadal 27203-92-5 0.67 16 Valcyclovir Hydrochloride Monohydrate 124832-27-5 0.33 17 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid

methyl ester 154477-54-0 0.10

18 N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine

116169-90-5 0.17

19 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol

142569-70-8 0.10

20 2,8-Diazo bicyclo Nonane 151213-42-2 0.17 21 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 20880-92-6 0.83 22 2- Acetyl Ethoxy acetyl methoxy ether 1.13 23 N,N-Carbonyl di imidazole 530-62-1 1.67



24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-diohenyl

183388-64-9 0.10

25 Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid 49708-81-8 0.10 26 Guanine 73-40-5 1.67 27 Poly allyl amine HCl 71550-12-4 0.50 28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-

(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate

0.17

29 5-Cyano phthalide 82104-74-3 0.67 30 1,1-Cyclohexanediacetic acid 07-11-4335 1.67 31 Carbamyl Methyl-5-Methyl hexanoic Acid 181289-15-6 0.50 32 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 161599-46-8 0.13 33 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine

amine 0.33

34 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid dihydrochloride

0.33

35 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide

0.17

Worst Case : 20 products on Campaign basis 14.20

List of By-Products – After Expansion S.No Name of Product Stage Name of By-Product Quantity

Kg/day TPM 1 Clopidogrel hydrogen sulfate I p-toluene sulfonic acid 180.8 5.4 2 1,1-Carbonyl diimidazole I Trichloromethanol 2782.5 83.5

Manufacturing Process

Chemical synthesis produces majority of API’s currently in the market. Chemical

synthesis consists of four steps - reaction, separation, purification, and drying. Large

volumes of solvents are used during chemical syntheses, extractions, and solvent

interchanges. The manufacturing process of the above mentioned molecules involve

various types of reactions like acetylyzation, protection, deprotection, hydrolysis etc.

The manufacturing process of all the compounds, reactions involved, material balance

are presented in chapter 2 of EIA report.

Utilities

The proposed expansion requires additional steam for both process and effluent

treatment system. It is proposed to establish coal fired boilers of capacity of 2 x 10 TPH in

addition to existing 2 TPH coal fired boiler. The DG sets required for emergency power

during load shut down is estimated at 2250 KVA and accordingly 2 x 1000 Kva DG sets



are proposed for expansion in addition to existing 1 x 250 Kva. The list of utilities is

presented in the following Table.

List of Utilities S.No Utility Permitted Proposed After Expansion

1 Coal Fired Boilers (TPH) 1 x 2 2 x 10

2 x 10 1 x 2

2 Thermic Fluid Heater (K.Cal) 1 Lac --- 1 Lac 3 DG Sets (kVA)* 1 x 250 2 x 1000 2 x 1000

1 x 250 *DG sets will be used during load shut down by TSPDCL.

Water Requirement

Water is required for process, scrubbers, washing, cooling tower makeup, steam

generation and domestic purposes. The total water requirement after expansion is 475.7

KLD out of which 300.73 KLD fresh water and 175 KLD of recycled water. The required

water shall be drawn from ground water in addition to reuse of treated wastewater. The

water balance for daily consumption is presented in the following table;

Water Balance Purpose INPUT (KLD) OUTPUT (KLD)

Fresh Water Recycled Water Loss Effluent Process 93.73 105.21* Washings 10 10 Scrubber 10 10 Boiler 95 85 10 Cooling Tower 60 165 199 26 RO/DM Rejects 24 24 Domestic 10 1.5 8.5 Water for gardening 8 8 Gross Total 300.73 175 293.5 193.71 Total 475.7 487.21

* Process effluents contain soluble raw materials, byproducts, solvents etc.

Baseline Environmental Data

The baseline data was collected in the study area during December 2016 - February 2017

The baseline data includes collection of Samples of ground water, surface water and soil,

monitoring of ambient air quality, noise levels, ecological status and meteorological

parameters. The analytical results show that the values are within the prescribed limits

for air quality. The ground water quality is observed to be above the limits for potable

purpose when compared to the prescribed standards of IS: 10500 – 2012 at few locations.



Identification and Quantification of Impacts

The impact assessment report has identified various sources of pollution and quantified

the pollution loads due to proposed unit. It has also identified the technologies to be

adopted for the mitigation and control of the same. The sources of pollution are air

emissions from utilities and process; liquid effluents from process, utilities and domestic

usage; solid wastes from process, treatment systems and utilities; and noise pollution

from utilities, and process equipment.

Impacts on Air quality: The impacts on air quality shall be due to the emissions from,

Coal Fired Boilers and standby DG sets. The incremental concentrations are quantified

using ISC-AERMOD model based on ISCST3 Algorithm. The results indicate marginal

increase in ambient air quality concentration. The predicted values for SPM, PM10, PM2.5,

SO2 and NOx are 3.5, 1.43, 0.67, 5.02 and 7.48 μg/m3 respectively at a distance of 0.5 km

in northwest direction, and the cumulative values of baseline air quality combined with

predicted values are found to be within the prescribed limits of National Ambient Air

Quality Standards. The mitigative and control measures of air pollution shall ensure that

the impact on air quality is local – within the site area and its surroundings. The fugitive

and diffuse emissions were quantified and a box model was used to predict air borne

concentrations, and the results indicate the work room concentrations less than threshold

limit values (TLV) for various solvents.

Impacts on Water: Water is essentially used for process and utilities and domestic

purposes. The total fresh water required of quantity 300.73 KLD after expansion will be

drawn from ground water sources in addition to recycled water of 175 KLD. No impact

on water quality is expected due to discharge of effluents as zero liquid discharge is

envisaged, which ensures reuse of treated effluents for cooling tower makeup and

scrubbers. There is no usage of treated water for on land irrigation. Impacts on Noise

quality: The noise levels may increase due to motors, compressors, DG set and other

activities. The major source of noise generation is DG set which emit noise level of

maximum 90 dB (A) at a reference distance of 1m from the source. The predicted

cumulative noise levels (as calculated by the logarithmic model without noise

attenuation) ranged between 55 and 75 dB(A) at distances of 8 to 15m. Impacts on Soil:

The solid wastes generated from process, utilities and effluent treatment plant may have



significant negative impacts if disposed indiscriminately. The total solid waste will be

stored separately in Hazardous storage area. Solid waste will be sent to cements plants

for co-incineration based on calorific value or sent to TSDF. The operational phase

impacts shall be neutral due to effective implementation of mitigative measures in

handling, storing and transferring of solid wastes, effluents and chemicals, and

development of green belt.

Impacts on Ecology: There are no endangered species of flora and fauna in the impact

area. The impact on biological environment is neutral with the effect confined mainly to

the site area.

Impacts on Socio Economy: There is a potential for direct/indirect employment of about

75 people during construction phase and 200 during operation phase. The impact area

with low industrial density will have positive benefits due to the project. The project

shall have positive impact on socioeconomic environment due to provision of

employment both direct and indirect and proposed CSR activities.

Environment Management Plan

The management plan is drawn in consultation with project proponents and technical

consultants after evaluating various mitigaton and control measures to address the

impacts identified, predicted and monitored. The impacts during construction stage are

temporary and less significant, the management plan for impacts identified during

operation stage is described as follows;

Liquid Effluents

The effluent generated from the proposed expansion is mainly from process, washings,

scrubbers, cooling towers & boiler blow downs, RO/DM rejects from pre-treatment of

water and domestic effluent. The effluents from process, washings, scrubber and

RO/DM rejects are considered as HTDS stream, while utility blow downs and domestic

wastewater are considered LTDS stream. It is proposed to treat HTDS effluents from

process and washing in stripper followed by MEE and ATFD, and MEE and ATFD in

the case of effluents from RO/DM backwash and scrubber. All LTDS effluent along with

condensate from MEE & ATFD shall be treated in Biological treatment followed by RO

system. RO Rejects sent to MEE and permeate is used for cooling towers as make up and



scrubbers. Total Effluent generated and mode of treatment before and after expansion is

presented as follows:

Total Effluent Generated and Mode of Treatment Description Quantity (KLD) Mode of Treatment

Permitted After Expansion

HTDS Effluents Process 4.52 105.21 Sent to Stripper followed by MEE and ATFD.

Stripper Condensate sent to Cement Plants for Co-Incineration. MEE and ATFD Condensate sent to Biological treatment plant followed by RO. RO rejects are sent to MEE and permeate is reused in cooling towers make-up and scrubbers.

Washings 1 10

Scrubber Effluent 10 Sent to MEE followed by ATFD, Biological treatment plant and RO. RO/DM Plant

Rejects 24

Total I 5.52 149.21 LTDS Effluents

Boiler Blow downs 1 10 Sent to Biological Treatment System followed by RO. RO permeate reused for cooling tower makeup and scrubbers. RO rejects sent to MEE.

Cooling Tower Blow downs

0.5 26

Domestic 1 8.5 Total II 2.5 44.5 Grand Total (I+II) 8.02 193.71

Effluent Treatment System

The Effluent management system is developed to ensure `Zero Liquid Discharge’.

Segregation of effluents is an integral part that facilitates effective treatment of various

effluent streams. The effluents are segregated into two streams; High COD/ TDS and

Low COD/ TDS streams.

The High TDS/ COD Effluents The treatment system for treating High TDS/ COD effluents consists of Equalization,

Neutralization, Settling tank, Stripper, Multiple Effect Evaporator (MEE) followed by

Agitated Thin Film Dryer (ATFD). The organic distillate from the stripper is sent to

cement plants for co-incineration and aqueous bottom from stripper is sent to MEE

followed by ATFD for evaporation. The condensate from the MEE and ATFD are sent to

ETP (Biological). Salts from ATFD are disposed to TSDF.



The Low TDS/ COD Effluents:

These effluents along with the condensate from MEE and ATFD are treated in primary

treatment consisting of equalization, neutralization, and primary sedimentation followed

by secondary biological treatment consisting of aeration tank and clarifier.

The treated effluents after biological treatment are subjected to tertiary treatment in a

reverse osmosis (RO) system. Permeate from RO is reused for cooling tower and boiler

make-up and rejects are sent to MEE followed by ATFD. Sludge from various units of

Biological treatment are thickened in sludge handling system and sent to TSDF.

Air Pollution

The sources of air pollution are from proposed 2 x 10 TPH coal fired boiler, existing 1 x 2

TPH and existing 1 Lakh K.Cal thermic fluid heater. Backup DG sets of 2 x 1000 KVA are

proposed in addition to existing DG sets of 1 x 250 KVA capacity to cater energy

requirement during load shut downs. Bag filter will be provided as air pollution control

equipment for 2 x 10 TPH coal fired boilers. DG sets shall be provided with effective

stack height based on the CPCB formula.

Process emissions contain Ammonia, Carbon dioxide, carbon monoxide, Hydrogen,

Hydrogen Bromide, Bromine, Hydrogen Chloride, and Sulfur dioxide. Ammonia,

Hydrogen chloride, Hydrogen Bromide, Bromine and Sulphur dioxide are sent to

scrubber in series. Ammonium Chloride from ammonia scrubbing, Sodium chloride

from HCl scrubbing, Sodium bromide from HBr and Bromine Scrubbing and Sodium

Bisulfite from Sulphur dioxide Scrubbing are sent to ETP. The other gases Carbon

dioxide and carbon monoxide are let out into atmosphere following a standard operating

procedure, while Hydrogen gas is let out into atmosphere through a water column.

Emissions are also released from various operations of manufacturing like centrifuge,

drying, distillation, extraction etc. These emissions mainly contain volatile contents of

the material used for processing. It is proposed to provide vent condensers in series to

reactors, distillation columns, driers and centrifuge etc. to mitigate VOC emissions

release. Other vents are connected to common headers and scrubbers.



Solvent Use and Recycle

Solvents are used for extraction of products and as reaction medium. Used solvents are

recovered by distillation, for reuse. Residues from distillation columns and mixed

solvents shall be sent to TSDF for incineration or cement plants for co-incineration. If any

of the distilled spent solvents are not reused due to statutory reasons the same shall be

sold to end users.

Solid Waste

Solid wastes are generated from process, solvent distillation, effluent treatment system,

DG sets and boilers. Stripper distillate, process residue and solvent residue are sent to

cement plants for co-incineration based on acceptability as the same contain significant

calorific value and are predominantly organic in nature. If these wastes are not suitable

for co-incineration, the same are sent to TSDF facility. The evaporation salts from ATFD ,

and sludge from ETP are sent to TSDF for landfill. Waste oil and used batteries from the

DG sets are sent to authorized recyclers. Other solid wastes expected from the unit are

containers, empty drums which are returned to the product seller or sold to authorized

buyers after detoxification. Coal ash from boiler is sold to brick manufacturers.

Noise Pollution

Noise is anticipated from motors, compressors, centrifuges and DG sets. DG set shall be

provided with acoustic enclosure. Motors and compressors shall be mounted properly to

ensure reduction of noise and vibration. Employees working in noise generating areas

shall be provided with appropriate personnel protective equipment.

Occupational Safety and Health

Direct exposure to chemicals or its raw materials may affect health of employees. Direct

exposure to hazardous materials is eliminated by providing closed handling facilities.

Personal Protective Equipment (PPE) i.e., hand gloves, safety goggles, safety shoes,

safety helmets, respiratory masks etc. are provided to all the employees working in the

plant. Company has a policy of providing PPEs to all personnel including contract

workers. Periodic medical checkup in addition to checkup during recruitment is adopted

to monitor health status of employees.



Prevention, maintenance and operation of Environment Control Systems

The pollution control equipment, and the effluent treatment system is monitored

periodically to estimate their efficiency and performance potential as part of adoptive

management. Proactive maintenance and monitoring program for all equipment and

machinery is adopted to identify the problems/under performance of the equipment.

Necessary measures will be adopted to rectify the identified problems/defects. The

management agrees that the results of monitoring will be reviewed periodically to adopt

new measures if necessary, for efficient pollution control.

Transport systems

All the raw materials and finished products are transported by road. Dedicated parking

facility is provided for transport vehicles. There will be 10-12 truck trip per day to the

factory for transporting raw materials and products. Traffic signs will be placed in the

battery limit. The drivers of vehicles will be provided with TREM cards of chemicals and

materials to be transported, and will be explained the measure to be adopted during

various emergencies

Reduce, Recycle and Reuse

A number of measures are proposed to achieve high yields and reduce generation of

wastes. It shall be endeavor of the R&D team to improve yields through constant

research and development activities. The solvents shall be recycled for reuse in the

process after distillation. Mother liquors from the first crop shall be reused for process.

The steam condensate shall be reused for boiler feed. Treated effluent shall be reused for

cooling tower makeup. It is also proposed to explore recovery of various salts from MEE

salts, and from process effluents to reduce effluent loads, and quantity of solid waste.

Green Belt Development

Green belt is recommended as one of the major components of EMP. The management

proposes to develop green belt in a total area of 11.5 acres, to enhance environmental

quality through mitigation of fugitive emissions, attenuation of noise levels, balancing

eco-environment, prevention of soil erosion, and creation of aesthetic environment.



Post Project Monitoring

Environmental monitoring for water, air, noise and solid waste quality shall be

conducted periodically either by proponent or third party. The frequency of monitoring

and the quality parameters shall be as suggested by the Ministry of Environment and

Forests and Climate Change, Government of India.

Environment Management Department

The Environment Management Cell of the project shall be headed by the Vice President

followed by Sr. GM Operation, senior manager EHS, Executive Environment and shall be

assisted Technicians and chemists of SHE cell, and horticulture staff.

Hazelo Lab Pvt. Ltd. Environmental Impact Assessment Report

Team Labs and consultants 1-1

1.0 INTRODUCTION

1.0 Introduction of the Project (Terms of Reference No. 2(ii) & 2(iii))

The pharmaceutical industry is an important component of health care systems

throughout the world; it is comprised of many public and private organizations that

discover, develop, manufacture and market medicines for human and animal health.

The pharmaceutical industry is based primarily upon the scientific research and

development (R&D) of medicines that prevent or treat diseases and disorders. Modern

scientific and technological advances are accelerating the discovery and development

of innovative pharmaceuticals with improved therapeutic activity and reduced side

effects. Industrial chemicals are used in researching and developing active drug

substances and manufacturing bulk substances and finished pharmaceutical products.

Chemical synthesis produces majority of drugs currently available in the market.

Chemical synthesis consists of four steps - reaction, separation, purification, and

drying. Large volume of solvents are used during chemical syntheses, extractions, and

solvent interchanges. The bulk drug manufacturing process utilizes various process

equipment and chemical methods. Sources of emissions include dryers, reactors,

distillation units, storage and transfer of materials, filtration, extraction, centrifugation,

and crystallization. Chemical synthesis consists of one or more batch reactions

followed by separation and purification steps utilizing organic and inorganic reactants,

solvents, and catalysts, and is solvent-intensive. Waste streams generated are numerous

and complex due to the raw materials used and the varied nature of operations.

Organic synthesis generates a mother liquor containing unconverted reactants, by-

products, and residual product in a solvent or aqueous base, as well as acids, bases,

metals, etc.

The scientific research and development in API manufacturing is focused on increasing

the yields and reducing the toxicity of wastes and consumption of solvents, using

alternative manufacturing methods etc. In this context the API manufacturing is

viewed as an environmentally hazardous activity. Accordingly Ministry of

Environment and Forests, GOI mandated prior environmental clearance for synthetic

organic chemicals manufacturing units vide S.O.1533 dt. 14.9.2006.



M/s. Hazelo Lab Pvt. Ltd (Formerly known as Venlar Labs (P) Ltd.) obtained consent

for operation vide letter no. TSPCB/RCP/NLG/16644/HO/2015-986 dt. 14.08.2015 for

manufacturing bulk Drug Intermediates at Sy.Nos. 240, 242, 243, 247, 248 and 249,

Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri district, Telangana. It

is proposed to expand the manufacturing capacity to 14.2 TPD by acquiring additional

land area of 29.16 acres with a capital cost of Rs. 45 Crores. Total land area after

expansion is 33.485 acres and the expansion mainly involves construction and

commissioning of additional production blocks, utilities and Zero Liquid Discharge

facility. Prior environmental clearance has to be obtained from Ministry of

Environment, Forest and climate change, vide SO 1533, dated September 14, 2006, for

synthetic organic chemicals manufacturing activity. The terms of reference for the

environmental impact assessment studies was obtained from MoEF&CC vide letter no.

F.No. J-11011/19/2016-IA II (I) dated 31.03.2016 as part of environmental clearance

process.

M/s. Hazelo Lab Pvt. Ltd., is conscious of its responsibility towards the society in

minimizing the pollution load due to the proposed expansion of synthetic organic

chemicals manufacturing and accordingly decided to carry out the Environmental

Impact Assessment to identify the negative and positive impacts and to delineate

effective measures to control the pollution and to mitigate the environmental pollution.

M/s. Hazelo Lab Pvt. Ltd., has appointed Team Labs and Consultants for the

preparation of Environmental Impact Assessment report.

Immediately after the receipt of the work order for the preparation of EIA report, the

collection of primary (field data) and secondary (data available with various state and

central government agencies) data has begun. Reconnaissance survey of the region

was carried out during of November 2016, and various sampling locations to monitor

environmental parameters have been identified. Subsequently, monitoring has

commenced for collection of data on meteorology, ambient air quality, surface and

ground water quality, soil characteristics, noise levels flora and fauna at the specified

locations during December 2016 - February 2017. The other studies such as socio-

economic profile, land use pattern etc are based on secondary data collected from



various Government agencies and validated through the primary surveys. The

Ambient air monitoring locations have been selected based on the initial Air dispersion

Modeling carried out by using the meteorological data generated at India

Meteorological Department (IMD).

Field team of M/s. Team Labs and Consultants worked in the study area during

December 2016 - February 2017 and base line data for various environmental

components i.e., air, water, soil, noise and flora and fauna and socio economic status of

people was collected in a circular area of 10 km radius by taking the industry site as the

center point, to assess the existing environmental status as per the guidelines specified

by Ministry of Environment, Forest and Climate Change (MoEF&CC), Government of

India. This report presents the results of environmental impact assessment study along

with the environmental management plan, necessary to avoid or mitigate the observed

environmental impacts of the proposed expansion of synthetic organic chemicals

manufacturing unit.

1.1 Product Profile (Terms of Reference No. 3(ii) & (iii))

The manufacturing capacity of permitted and after expansion products are presented in

Table 1.1 and Table 1.2. List of By-products after expansion is presented in Table 1.3.

Table 1.1 Manufacturing Capacity - Permitted S.No Name of Product Capacity

Kg/Day TPA Group A*

1 α-Amino compound 100 30 2 Pyrazole 100 30

Total 200 60 Group B*

3 Bromophthalide 100 30 4 Cyanodiol HBr 150 45 5 Cyanophtalide 100 30

Total 350 105 Note: The above products are manufactured on campaign basis, i.e. at any point of time only one group will be manufactured.



Table 1.2 Manufacturing Capacity – After expansion S.No Name of Product CAS No. Capacity

(TPD) 1 Amlodipine Besylate 88150-42-9 0.33 2 Bupropion HCl 34841-39-9 0.83 3 Clopidogrel Hydrogen Sulfate 113665-84-2 0.33 4 Desvelofloxin Succinate 386750-22-7 0.17 5 Divolproex Sodium 76584-70-8 0.57 6 Dulaxetine HCl 136434-34-9 0.17 7 Esomeprazole Mg Dihydrate 217087-09-7 0.33 8 Glimepiride 93479-97-1 0.17 9 Mesalamine 89-57-6 0.17 10 Metaprolol Succinate 37350-58-6 0.50 11 Pantoprazole Sodium Sesquihydrate 138786-67-1 0.50 12 Pragabalin 148553-50-8 0.50 13 Rosuvastatin Calcium 287714-41-4 0.10 14 Sertraline HCl 79559-97-0 0.33 15 Tramadal 27203-92-5 0.67 16 Valcyclovir Hydrochloride Monohydrate 124832-27-5 0.33 17 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid

methyl ester 154477-54-0 0.10


116169-90-5 0.17


142569-70-8 0.10

20 2,8-Diazo bicyclo Nonane 151213-42-2 0.17 21 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 20880-92-6 0.83 22 2- Acetyl Ethoxy acetyl methoxy ether 1.13 23 N,N-Carbonyl di imidazole 530-62-1 1.67 24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino

1,6-diohenyl 183388-64-9 0.10



0.17


amine 0.33


0.33


0.17




Table 1.3 List of By-Products – After Expansion S.No Name of Product Stage Name of By-Product Quantity

Kg/day TPM 1 Clopidogrel hydrogen sulfate I p-toluene sulfonic acid 180.8 5.4 2 1,1-Carbonyl diimidazole I Trichloromethanol 2782.5 83.5

1.2 Technology The technology for the product profile is indigenous based on organic chemistry. The

product profile has been finalized based on the market demand and the technology

compatibility. The synthesis involves reaction of fine chemicals in a solvent medium,

followed by separation and purification.

1.3 Plant Location & Layout

The project site is located at Survey Number 240, 242, 243, 247, 248 and 249,

Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanangiri District, Telangana.

The site is located at the intersection of 170 17’ 17” (N) latitude and 780 50’ 46” (E)

longitude. The site elevation above mean sea level (MSL) is 407 m. The site is

surrounded by open land in north, west and south directions and SVR Laboratries Pvt.

Ltd., in east direction. The nearest habitation form the site is Antammagudem located

at a distance of 0.65 km in east direction. The main approach road is Dothigudem –

NH9 connecting road in west direction. National Highway-9 is at a Distance of 2.8 Km

in Southwest Direction to the site. The nearest Town is Choutuppal at a distance of 5.6

km in southeast direction and nearest airport is Shamshabad located at a distance of 44

km in southwest direction. Chinna Musi River is passing from NW to NE at a Distance

of 5.8 Km in NW direction to the site. There are seven reserve forests in the study area;

Lakkaram RF at a distance of 1.2 km in south direction, Chauttuppal RF at a distance of

4.8 km in northwest direction, Malkapuram RF at a distance of 2.2 km in west direction,

Hafeezpura RF at a distance of 7 km in southwest direction, Ailaupur RF at a distance

of 6.7 km in southwest direction, Meharnagar RF at a distance of 5.3 km in northwest

direction and Jalalpur RF at a distance of 6.7 km in northwest direction are in the

impact area. There is no National Park, Wildlife sanctuary, ecologically sensitive area,

critically polluted area and interstate boundary within the impact area of 10 km

surrounding the site. The location map and site layout is as shown in Fig 1.1 and Fig

1.2.



Fig 1.1 Location of M/s. Hazelo Lab Pvt. Ltd., (Terms of Reference No. 4(ii))



Fig 1.2 Plant Layout of M/s. Hazelo Lab Ltd., (Terms of Reference No. 4(vi) & (viii))

S C A L E 1 C m = 0 0 m trs

P R O D U C T IO N B L O C K4 0 .0 x 1 2 .5

P R O P O S E D B L O C K4 0 .0 x 1 9 .0

4 0 .0 x 1 2 .5

8 .0 X 1 2 .5 MR O A D 5 .0 M

D CP R O P O S E D

1 4 .0 X 1 2 .5 MT A N K S

R O A D 5 .0 M

R O A D 7 .0 M

S O L V E N T Y A R D4 5 .3 x 6 0 .0

L R M -II

4 0 .0 x 2 0 .0

U N L O A D IN G

P R O P O S E D B L O C K4 0 .0 x 1 9 .0

I N T E R M E D IA T E S T O R A G E

Q C & Q A

P R O P O S E D

7 0 .0 x 1 9 .0

P R O P O S E D S E R V IC E B L O C K7 0 .0 x 1 2 .5

R O A D 5 .0 M

4 0 .0 x 2 0 .0

2 8 .0 x 2 0 .0

4 0 .0 x 2 0 .0

7 0 .0 x 2 0 .0

R O A D 5 .0 M

4 0 .0 x 2 0 .0

4 0 .0 x 2 0 .0

7 0 .0 x 2 0 .0

R O A D 5 .0 M 2 5 .0 x 1 2 .5

B O IL E R2 0 .0 x 1 2 .5

C O A L S H E D

P R O P O S E D B L O C KP R O P O S E D B L O C K

W A R E H O U S E -I

L R M -I

5 0 .0 x 2 0 .0

4 0 .0 x 2 0 .0

W A R E H O U S E -II

C A N T E E N &C H A N G E R O O M S

P R O P O S E D B L O C K

P R O P O S E D P IL O T P L A N T

1 0 .0 x 1 0 .0

T E M P L E

F U T U R E

F U T U R E

F U T U R E

Z L D S y s te m

F U T U R E F U T U R E

F U T U R E F U T U R EF U T U R E

S T O R M W A T E RP O N D



1.4 Scope of EIA Studies

EIA study involves three basic components, viz. identification, prediction and

evaluation of impacts. The scope of EIA study incorporating the Terms of reference

(TOR) obtained from the MoEF is as follows:

• An intensive reconnaissance and preliminary collection of environmental

information to plan field study.

• Field studies to collect preliminary information, particularly on the quality of

the physical environment. Experienced scientists and engineers will collect the

data.

• Base line data generation and characterization of air, water, soil, noise and

vegetation in the ten kilometer radius area (impact zone) over a period of Three

months.

• A thorough study of the process including provisions for pollution control, and

environmental management that includes prediction of impacts and relevant

mathematical modeling.

• Preparation of Environmental Monitoring Program.

• Preparation of Environmental Management Plan suggesting suitable methods

for mitigating and controlling the pollution levels. Environmental Monitoring

Plan is suggested for monitoring the pollution loads at various facilities in the

premises and to ensure compliance with the statutory requirements.

Hazelo Lab Pvt. Ltd., Environmental Impact Assessment Report

2-1 Team Labs and Consultants

2.0 PROCESS DESCRIPTION AND POLLUTION CONTROL FACILITIES

M/s. Hazelo Lab (P) Ltd (Formerly known as Venlar Labs (P) Ltd.,) obtained consent for

operation for Bulk Drug Intermediates at Sy.Nos. 240, 242, 243, 247, 248 and 249,

Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri district, Telangana. It is

proposed to expand the manufacturing capacity from 0.35 TPD to 14.2 TPD to meet the

increasing market demands by acquiring additional land area of 29.16 acres, total land area

after expansion is 33.485 acres. The expansion entails a capital cost of Rs. 45.0 Crores

towards additional production blocks, utilities and Zero Liquid Discharge facility.

Manufacturing Capacity permitted and after Expansion is presented in Table 2.1 and 2.2.

List of By-Products presented in Table 2.3.

Table 2.1 Manufacturing Capacity - Permitted S.No Name of Product Capacity

Kg/Day TPA Group A*

1 α-Amino compound 100 30 2 Pyrazole 100 30

Total 200 60 Group B*

3 Bromophthalide 100 30 4 Cyanodiol HBr 150 45 5 Cyanophtalide 100 30

Total 350 105 Note: The above products are manufactured on campaign basis, i.e. at any point of time only one group will be manufactured.

Table 2.2 Manufacturing Capacity - after Expansion

S.No Name of Product CAS No. Capacity (TPD)

1 Amlodipine Besylate 88150-42-9 0.33 2 Bupropion HCl 34841-39-9 0.83 3 Clopidogrel Hydrogen Sulfate 113665-84-2 0.33 4 Desvelofloxin Succinate 386750-22-7 0.17 5 Divolproex Sodium 76584-70-8 0.57 6 Dulaxetine HCl 136434-34-9 0.17 7 Esomeprazole Mg Dihydrate 217087-09-7 0.33 8 Glimepiride 93479-97-1 0.17 9 Mesalamine 89-57-6 0.17 10 Metaprolol Succinate 37350-58-6 0.50 11 Pantoprazole Sodium Sesquihydrate 138786-67-1 0.50



12 Pragabalin 148553-50-8 0.50 13 Rosuvastatin Calcium 287714-41-4 0.10 14 Sertraline HCl 79559-97-0 0.33 15 Tramadal 27203-92-5 0.67 16 Valcyclovir Hydrochloride Monohydrate 124832-27-5 0.33 17 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid

methyl ester 154477-54-0 0.10


116169-90-5 0.17


142569-70-8 0.10

20 2,8-Diazo bicyclo Nonane 151213-42-2 0.17 21 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 20880-92-6 0.83 22 2- Acetyl Ethoxy acetyl methoxy ether 1.13 23 N,N-Carbonyl di imidazole 530-62-1 1.67 24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino

1,6-diohenyl 183388-64-9 0.10



0.17


amine 0.33


0.33


0.17


Table 2.3 List of By-Product - after Expansion

S.No Name of Product Stage Name of By-Product Quantity Kg/day TPM

1 Clopidogrel hydrogen sulfate I p-toluene sulfonic acid 180.8 5.4 2 1,1-Carbonyl diimidazole I Trichloromethanol 2782.5 83.5



2.1 Process Description: (Terms of Reference No. 3(viii))

2.1.1 Process Description of Amlodipine Besylate

Reaction Schemes

Stage I

NO

O

OC O O C 2 H 5C H 3 O O C

CH 3

C l

NH

N H 2O

C O O C 2 H 5C H 3 O O C

CH 3

C l

NH

P h t h a l i m i d o A m l o d i p i n e

B e n z e n e s u l f o n i c a c i d ( 1 5 8 )

A m l o d i p i n e B e s y l a t e ( P h a r m a )

+ M o n o m e t h y l a m i n e

M . W t : 5 3 9

M . W t : 5 6 7

M e t h y l e n e C h l o r i d e

+P h t h a l i c a c i d

M . W t : 1 6 6

2 H 2 O

M . W t : 3 6

. B e n z e n e s u l f o n i c a c i d

Process Description: Stage – I: Phthalimido amlodipine is treated with benzene sulphonic acid in presence of

Mono methyl amine to give Amlodipine besylate (Pharma). Process flow diagram can be

represented in Fig 2.2. Material balance represented in Table 2.4.

S a lt fo r m a t io n

P h th a lim id o A m lo d ip in e

A m lo d ip in e b e s y la te (P h a rm a )

M o n o m e th y l a m in e

B e n z e n e S u lp h o n ic a c id

M e th y le n e c h lo r id e

M e th a n o l

E th y l a c e ta teW a te r

N a C l

S o d iu m b is u lp h a te

A c tiv a te d c a r b o n

P h th a lic a c id

W a s te W a te r

A c tiv a te d c a r b o n

D e p r o te c t io n

&

Fig 2.1 Process Flow Diagram of Amlodipine Besylate



Table 2.4 Material Balance for Amlodipine Besylate Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

Phthalimido Amlodipine 425 Amlodipine Besylate 333.3 Final Product Water 28 Phthalic acid 97.6 To wastewater Methylene Chloride (MDC)

1200 Methanol Recovered 1425 Recovery & reuse

Mono Methyl amine (MMA)

750 Methanol Loss 12 Fugitive Loss

Benzene sulfonic acid 125 Methanol to wastewater 9 To Wastewater Sodium Chloride 150 Methanol to Residue 54 Solvent in Residue Sodium Bisulphate 80 MDC Recovered 1152 Recovery & reuse Methanol 1500 MDC Loss 8.4 Fugitive Loss Ethyl acetate 800 MDC to Residue 39.6 Solvent in Residue Activated Carbon 20 Ethyl acetate Recovered 736 Recovery & reuse Celite 12 Ethyl acetate Loss 3.2 Fugitive Loss Water 3500 Ethyl acetate to water 8.8 To Wastewater Ethyl acetate to Residue 52 Solvent in Residue MMA Recovered 720 Recovery & reuse MMA Loss 5.3 Fugitive Loss MMA to wastewater 9.8 To Wastewater MMA to Residue 14.9 Solvent in Residue Phthalimido Amlodipine 107.9 Organic Residue Benzene sulfonic acid 32 To wastewater Activated Carbon 20 To Spent carbon Sodium Chloride 150 To Wastewater Sodium Bisulphate 80 To Wastewater Celite 12 Inorganic residue water 3507 To Wastewater Total Input 8589.6 Total Output 8589.6



2.1.2 Process Description of Bupropion Hydrochloride Reaction Schemes Stage I

C l C H 3

O

CH 3

C H 3

C H 3

N H 2

C l

O

NH

C H 3

C H 3

C H 3

C H 3

H C l+ +

m -C h lo ro p ro p io p h e n o n eM .W t : 1 6 8 .5

T e r t-b u ty la m in eM .W t : 7 3

M .W t : 2 7 6

.H C l

+ B r 2

B ro m in eH yd ro g e nc h lo r id e

M .W t : 3 6 .5M .W t : 1 6 0

+ 2 H B r

M .W t : 1 6 2

N a 2 S 2O 5

N a 2S 2 O 3

T o lu e n e

B u p ro p io n H yd ro c h lo r id e (C ru d e )

Stage II

Bupropion Hydrochloride (Crude)Methanol

AcetoneBupropion Hydrochloride (Pharma)

Process Description:

Stage – I: M-Chloropropiophenone is reaced with Tert-butylamine, hydrogenchloride and

bromine in presence of sodium bisulphate in methylene chloride to yield Bupropion

Hydrochloride (Crude).

Stage – II: Bupropion Hydrochloride (Crude) is purified in presence of Methanol and

acetone to give Bupropion Hydrochloride (Pharma). The process flow diagram for

Bupropion Hydrochloride is presented in Fig 2.2. Material balance presented in Table 2.5.



Bupropion Hydrochloride (Pharma)

m-chloropropiophenone

Tert-butylamine

Hydrogenchloride

Bromine

Sodiummeta bisulphate

N-methyl-2-pyrrolidone

Sodiumthiosulfate

Methylene chloride

Toluene

Acetone

Water

Buropipon Hydrchloride Crude

Hydrogen Bromide

N-methyl-2-pyrrolidone

Methylene chloride

Toluene

Acetone

Waste Water

Stage - I

Acetone Stage - II

Buropipon Hydrchloride Crude

Methanol

Activated Carbon

Methanol

Acetone

Fig 2.2 Process Flow Diagram of Bupropion Hydrochloride



Table 2.5 Material Balance for Bupropion Hydrochloride Stage I Input Quantity


(Kg/day) Remarks

m-Chloropiophenone 617.1 Stage I Product 902.6 To Stage II Tert-butylamine 267.3 Hydrogen bromide 529.8 To Scrubber Hydrogen Cloride 133.7 NMP Recovered 482.5 Recoverd & Reused Bromine 523 NMP Loss 2.5 Fugitive Loss Sodiummeta bisulfite 200 NMP to Wastewater 5 To Wastewater Sodium thiosulphate 160 NMP to Residue 100 Solvent in Residue N-methyl Pyrrolidone 500 MDC Recovered 2910 Recoverd & Reused Methylene chloride (MDC)

3000 MDC Loss 12 Fugitive Loss

Toluene 3200 MDC to Residue 78 Solvent in Residue Acetone 750 Toluene Recovered 3104 Recoverd & Reused Water 3200 Toluene Loss 12.8 Fugitive Loss Toluene to Residue 83.2 Solvent in Residue Acetone Recovered 723.8 Recoverd & Reused Acetone Loss 3.8 Fugitive Loss Acetone to Wastewater 7.5 To Wastewater Acetone to Residue 15 Solvent in Residue m-Chloropiophenone 66 Organic Residue Tert-butylamine 28.6 To waste water Hydrogen Chloride 14.3 To Scrubber Sodiummeta bisulfite 200 To Wastewater Sodium thiosulphate 160 To Wastewater Water 3200 To Wastewater Total Input 12551.4 Total Output 12551.4 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 902.6 Bupropion HCl 833.3 Final Product Methanol 2800 Methanol Recovered 2702 Recovered & Reused Acetone 3000 Methanol Loss 14 Fugitive Loss Activated Carbon 30 Methanol to Residue 84 Solvent in Residue Acetone Recovered 2910 Recovered & Reused Acetone Loss 12 Fugitive Loss Acetone to Wastewater 15 To Wastewater Acetone to Residue 63 Solvent in Residue Stage I Product 69.3 Organic residue Activated Carbon 30 To Spent carbon Total Input 6732.6 Total Output 6732.6



2.1.3. Process Description of Clopidogrel Hydrogen Sulfate

Reaction Schemes:

OS

S

OO

C H 3

O OC H 3

NH 2

C l

NH

S C l

C O O C H 3

NH

S C l

C O O C H 3

N

S C l

C O O C H 3

OHO H

O

O H

O H

OS O 3 H

C H 3

( 2 - T h ie n y l ) e t h y lp a r a - t o u le n es u lp h o n a t e

D ip o t a s s iu m h y d r o g e n p h o s p h a t e

E t h y l a c e ta te. T a r t a r ic a c id s a l t

M e t h y l ( + ) - a lp h a - a m in o ( 2 - c h lo r o p h e n y l)a c e t a t e t a r t a r ic a c id s a l t

+

L iq . A m m o n ia

M e t h y l ( + ) - a lp h a - ( 2 - t h ie n y le t h y la m in o )( 2 - c h lo r o p h e n y l ) a c e ta t e

H C l

S T A G E - I

S T A G E - I I

M e th y l ( + ) - a lp h a - ( 2 - t h ie n y le t h y la m in o ) ( 2 - c h lo r o p h e n y l ) a c e t a t e

A c e t o n eL ( - ) c a m p h o r s u lp h o n ic a c id

E th y l a c e ta t e

S o d iu m b ic a r b o n a te

. H S O 4

-

C l o p i d o g r e l h y d r o g e n s u l f a t e ( P h a r m a )

A c t iv a te d c a r b o n

M . W t : 3 4 9 . 5M .W t : 2 8 2

M .W t : 3 0 9 . 5

+ +

T a r ta r ic a c id

M . W t : 1 5 0 M . W t : 1 7 2

M . W t : 3 0 9 . 5

M .W t : 4 1 9 . 5

+ H C H O + H 2 S O 4

M .W t : 3 0 M . W t : 9 8

+ H 2 O

M . W t : 1 8

p - T o lu e n e s u l f o n ic a c id

W a te r

W a t e r


Stage-I: Methyl(+)-alpha-amino(2-chlorophenyl)acetate tartaric acid salt is condensed with

(2-thienyl)ethylpara-toulene sulphonate in the presence of Liq. Ammonia in ethyl acetate

and water to give methyl(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate.

Stage-II: methyl(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate is condensed with

formaldehyde and on treatment with sulfuric acid in the presence of acetone and water to

yield Clopidogrel hydrogen sulfate (Pharma). Process flow diagram can be presented in Fig

2.3.Material balance can be presented in Table 2.6.



Methyl(+)-alpha-amino(2-chlorophenyl)acetate tartaric acid

(2-Thienyl)ethylpara-toulenesulphonate

Liq.Ammonia

Methylene dichloride

Dipotassim hydrogen phosphate

Ethyl acetate

Hydrochloric acid

Condenisation

Methy(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate

Liq.Ammonia


Dipotassim hydrogen phosphate

Ethyl acetateHydrochloric acidTartaric acid

P-Toulene sulphonic acid

Stage-I

Stage-II

Cyclisation

Methy(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate

Formaldehyde

Sulfuric acid

AcetoneMethylene dichloride

L(-)-camphor sulphonic acidEthyl acetate

Sodium bicarbonateMethyl isobutyl ketone

Activated carbon

Acetone


L(-)-camphor sulphonic acid

Ethyl acetate

Sodium bicarbonate

Methyl isobutyl ketone

Activated carbon

Saltification

Clopidogrel hydrogen sulfate(Pharma)

Water Waste water

Water

Waste water

Fig 2.3 Process Flow Diagram of Clopidogrel Hydrogen Sulfate



Table 2.6 Material Balance for Clopidogrel Hydrogen Sulfate Stage I Input Quantity


(Kg/day) Remarks

Methyl(+)-alpha-amino(2-chlorophenyl)acetate tartaric acid salt

421.4 Stage I Product 325.4 To Stage II

(2-Thienyl)ethyl para-toulene sulphonate

340 Tartaric acid 157.7 To Wastewater

Liq. Ammonia (20%) 60 p-toluene sulfonic acid 180.8 By-Product Methylene Dichloride (MDC)

800 MDC Recovered 772 Recovered & Reused

Dipotassium hydrogen phosphate

54 MDC Loss 4 Fugitive Loss

Ethyl acetate 1000 MDC to Residue 24 Solvent in Residue Hydrochloric acid 26 Ethyl acetate Recovered 970 Recovered & Reused Water 1800 Ethyl acetate Loss 4 Fugitive Loss Ethyl acetate to water 5 To Wastewater Ethyl acetate to Residue 21 Solvent in Residue Methyl(+)-alpha-

amino(2-chlorophenyl)acetate tartaric acid salt

53.9 Organic Residue

(2-Thienyl)ethyl para-toulene sulphonate


Dipotassium hydrogen phosphate

54 Inorganic residue

Water 1848 To Wastewater Ammonium Chloride 37.8 To Wastewater Total Input 4501.2 Total Output 4501.2 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 325.4 Clopidogrel Hydrogen Sulfate

333.3 Final Product

Formaldehyde 31.5 Ethyl acetate Recovered 1447.5 Recovered & Reused Sulfuric acid 103 Ethyl acetate Loss 7.5 Fugitive Loss Acetone 1200 Ethyl acetate to water 15 To Wastewater L-(-)-Camphor sulphonic acid

15 Ethyl acetate to Residue 30 Solvent in Residue

Methylene dichloride (MDC)

2000 MIBK Recovered 1164 Recovered & Reused

Ethyl acetate 1500 MIBK Loss 4.8 Fugitive Loss Sodium bicarbonate 60 MIBK to Wastewater 6 To Wastewater Methyl isobutyl ketone 1200 MIBK to Residue 25.2 Solvent in Residue



(MIBK) Activated Carbon 40 MDC Recovered 1930 Recovered & Reused Water 1500 MDC Loss 10 Fugitive Loss Sodium hydroxide 20.5 MDC to Residue 60 Solvent in Residue Acetone Recovered 1158 Recovered & Reused Acetone Loss 6 Fugitive Loss Acetone to Wastewater 18 To Wastewater Acetone to Residue 18 Solvent in Residue Stage I Product 79.5 Organic Residue L-(-)-Camphor

sulphonic acid 15 Organic Residue

Formaldehyde 7.7 Organic Residue Activated Carbon 40 To Spent carbon Sodium sulfate 36.5 To Wastewater Sodium bicarbonate 60 To Wastewater Water 1523.5 To Wastewater Total Input 7995.5 Total Output 7995.5

2.1.4 Process Description of Desvelofloxin

Reaction Schemes Stage I

Hydrogen

MethanolPd/C

Stage II




Stage–I: 1-[2-Amino- 1-(4-benzyloxyphenyl) ethyl] cyclohexanol reacted with formic acid

and formaldehyde in presence of water gives 1-[2-(Dimethylamino)-1-(4-benzyloxyphenyl)

ethyl] cyclohexanol this undergoes to reacted with pd/c and Hydrogen gas pressure in

presence of methanol to gives 1-[2-Dimethylamino)-1-(4-hydroxyphenyl) ethyl]

cyclohexanol.

Stage–II: 1-[2-(Dimethylamino)-1-(4-hydroxyphenyl) ethyl] cyclohexanol reacted with

succinic acid Inpresence of isopropyl alcohol to gives Des-Venlafaxine succinate.Process

flow diagram can be represented in Fig 2.4.Material balance represented in Table 2.7.

Fig 2.4 Process Flow Diagram of Desvelofloxin



Table 2.7 Material Balance for Desvelofloxin Succinate Stage I Input Quantity


(Kg/day) Remarks

1-[2-Amino-1-(4-benzyloxyphenyl) ethyl] cyclohexanol


Formic acid 53.3 Toluene 43.8 To Wastewater Formaldehyde (40%) 86.9 Carbon dioxide 41.8 Let out into

Atmosphere 10% Pd/C 15 Ethyl acetate Recovered 1447.5 Recoverd & Reused Hydrogen gas 1.2 Ethyl acetate Loss 7.5 Fugitive Loss Water 3000 Ethyl acetate water 15 To Wastewater Ethyl acetate 1500 Ethyl acetate to Residue 30 Solvent in Residue n-hexane 1000 n-hexane Recovered 970 Recoverd & Reused Methanol 1200 n-hexane Loss 4 Fugitive Loss Isopropyl alcohol (IPA) 300 n-hexane to Residue 26 Solvent in Residue Methanol Recovered 1164 Recoverd & Reused Methanol Loss 4.8 Fugitive Loss Methanol to waste water 14.4 To Wastewater Methanol to Residue 16.8 Solvent in Residue IPA Recovered 292.5 Recoverd & Reused IPA Loss 1.2 Fugitive Loss IPA to waste water 3.6 To Wastewater IPA to Residue 2.7 Solvent in Residue Organics Organic Impurities 33.9 Organic Residue Formic acid 9.6 To waste water Formaldehyde 6.3 Organic Residue 10% Pd/C 15 To spent Catalyst Water 3069.2 To Wastewater Hydrogen gas 0.2 Let out Into

atmosphere through water column

Total Input 7344.8 Total Output 7344.8 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 125.1 Des-venlafaxine Succinate 166.7 Final Product Succinic acid 51.6 IPA Recovered 482.5 Recovered & Reused Isopropyl alcohol (IPA) 500 IPA Loss 2.5 Fugitive Loss IPA to Wastewater 5 To Wastewater IPA to Residue 10 Solvent in Residue Stage I Product 10 Organic Residue Total Input 676.7 Total Output 676.7



2.1.5 Process Description of Divolproex Sodium Reaction Schemes Stage I

Stage II


Stage –I: 2, 2-Dipropylmalonic acid is heat to 170 to 175 0C to form 2- Propylpentanoic acid

(Stage II Compound)

Stage –II: 2- Propylpentanoic acid reats with Sodium hydroxide inpresence of Methanol to

form Divalproex Sodium.Process flow diagram can be presented in Fig 2.5.Material balance

can be presented in Table 2.8.

Stage I

Stage II



Fig 2.5 Process Flow Diagram of Divolproex Sodium

Table 2.8 Material Balance for Divolproex Sodium Stage I Input Quantity


(Kg/day) Remarks

2,2-Dipropylmalonic acid

778.7 Stage I Product 578.6 To Stage-II

Carbon dioxide 176.8 Let out into atmosphere Organics 2,2-Dipropylmalonic

acid 23.4 Organic residue

Total Input 778.7 Total Output 778.7 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 578.6 Divolproex Sodium 566.7 Final Product Sodium hydroxide 73.9 Water 32.9 To wastewater Methanol 2000 Solvents Activated carbon 30 Methanol Hydrochloric acid 1 Methanol Recovered 1940 Recovery & reuse Methanol Loss 5 Fugitive Loss Methanol to Residue 55 Solvent in Residue Organics 2-Propylpentanoicacid 52.07 Organic residue Activated carbon 30 To Spent carbon Inorganics Sodium chloride 1.2 To Waste water Sodium hydroxide 0.8 To Neutralization Water 0.36 To Waste water Total Input 2683.2 Total Output 2683.2



2.1.6 Process Description of Dulaxetine HCl Reaction Schemes Stage I

SNC H 3

O O

O

SNH

O

C H 3 O O N a

O

D u lo x e t in e H yd ro c h lo rid e (P h a rm a )

(S )-N -M e th yl-N -p h e n ylo x yc a rb o n yl-3 -(1 -n a p th ylo x y)-3 -(2 -th ie n yl)p ro p yla m in e

M .W t: 4 1 7

+

S o d iu m p h e n yl c a rb o n a te

M .W t: 1 6 0

M .W t:4 0D im e th yl s u lp h o x id e

M .W t: 3 3 3 .5

E th yl a c e ta teE th yl a c e ta te .H C l

.H yd ro c h lo ric a c id

S o d iu m h yd ro x id e

M .W t:1 2 4 .5

+

C 2H 5C O O C H 3

E th yl a c e ta te

M .W t: 8 8


Stage I: (S)-N-Methyl-N-phenyloxycarbonyl-3-(1-napthyloxy)-3-(2-thienyl)propylamine is

resolved with sodium hydroxide in the presence of dimethyl sulfoxide to give (S)-N-

Methyl-3-(1-napthyloxy)-3-(2-thienyl)propylamine which is reacted with Ethyl

acetate.hydrochloric acid to yield Duloxetine hydchloride (Pharma). Process flow diagram

can be represented in Fig 2.6.Material balance can be presented in Table 2.9.

Duloxitene Hydrochloride (Pharma)

Wastewater

(S)-N-Methyl-N-phenyloxycarbonyl-3- (1-napthyloxy)-3-(2-thienyl) propylamine

Dimethyl sulphoxide

Sodium hydroxide

Ethyl acetate

Water

Activated carbon

(S)-N-Methyl-3-(1-napthyloxy)-3-(2-thienyl) propylamine

Sodium phenyl carbonate

Ethyl acetate

Dimethyl sulphoxide

Ethyl acetate.HCl

Base hydrolysisisfollowed

by saltification

Fig 2.6 Process Flow Diagram of Dulaxetine HCl



Table 2.9 Material Balance for Dulaxetine HCl Input Quantity


(Kg/day) Remarks

(S)-N-Methyl-N-phenyl oxycarbonyl-3-(1-napthyloxy)-3-(2-thienyl)propylamine

242.7 Duloxetine HCl 166.7 Final Product

Dimethyl sulphoxide (DMSO)

1722 Sodium Phenyl carbonate

80 Organic residue

Sodium hydroxide flakes 38.3 Ethyl acetate 44 Recovery & reuse Ethyl acetate 62.2 DMSO Recovered 1635.9 Recovery & reuse Activated Carbon 20 DMSO Loss 13.8 Fugitive Loss Water 1100 DMSO to Residue 72.3 Solvent in Residue Ethyl acetate. HCl 20 Ethyl acetate

Recovered 1140 Recovery & reuse

Ethyl acetate 1200 Ethyl acetate Loss 9.6 Fugitive Loss Hydrochloric acid 16.7 Ethyl acetate to

wastewater 36 To Wastewater

Ethyl acetate to Residue

14.4 Solvent in Residue

(S)-N-Methyl-N-phenyl oxycarbonyl-3-(1-napthyloxy)-3-(2-thienyl)propylamine

34.2 Organic residue

Ethyl acetate.HCl 20 To waste water Sodium Chloride 27 To Wastewater Activated Carbon 20 To spent carbon Water 1108.2 To Wastewater Total Input 4421.8 Total Output 4421.8



2.1.7 Process Description of Esomeprazole Mg Trihydrate Reaction Schemes Stage I

NS

N

N

CH 3

O C H 3

C H 3 O OC H 3

NS

N

N

CH 3

O C H 3

C H 3 O OC H 3

E s o m e p ra z o le m a g n e s iu m d ih y d ra te (P h a rm a )

(+ ) O m e p ra z o leM .W t: 3 4 5

2 H 2 OM g C l2M .W t: 9 5 M .W t: 3 6

++

+2 H C l

M .W t: 4 0 5

M .W t: 7 3

(S ) -C a m p h o r s u lfo n y l c h lo r id e

H yd ro g e n g a s (2 )

.M a g n e s iu m D ih y d ra te

Process Description: Stage-I: (±) Omeprazole is resoluted with (S)-Camphor sulfonyl chloride and then treated

with magnesium chloride and water to yield Esomeprazole Magnesium Dihydrate

(Pharma). Process flow diagram is presented in Fig 2.7.Material balance is presented in

Table 2.10.

W a te r

W a ste w a te r

M e th y le n e ch lo rid e

E so m e p ra z o le m a g n e siu m d ih y d ra te (P h a rm a )

M e th y le n e ch lo r id e

A ctiv a te d ca rb o n

A ctiv a te d ca rb o n

A ce to n e

H y d ro ch lo r ic a c id

A ce to n e

(+ ) O m e p ra z o le

4 -D im e th y la m in oN ,N -D iiso p ro p y l e th y la m in e

A ce tic a c id

S o d iu m ch lo r id eE th a n o l

S o d iu m h y d ro x id e L y e

M e th a n o l

M e g n e siu m ch lo r id e

4 -D im e th y la m in o p y r id in e

N ,N -D iiso p ro p y l e th y la m in e

A ce tic a c id

E th a n o l

M e th a n o l

P o ta ss iu m h y d ro x id e p o w d e r

(S )-C a m p h o r su lfo n y l ch lo r id e

R e so lu tio n

&S a ltfo rm a tio n

H y d ro g e n g a s

Fig 2.7 Process Flow Diagram of Esomeprazole Mg Trihydrate



Table 2.10 Material Balance for Esomeprazole Mg Dihydrate Input Quantity


(Kg/day) Remarks

(±) Omeprazole 321.2 Esomeprazole Mg Dihydrate

333.3 Final Product

Methylene dichloride (MDC)

5472 Hydrogen Chloride 60.1 To scrubber

4-Dimethylamino pyridine 24 Methanol Recovered 1900 Recovery & reuse N,N-Diisopropyl ethylamine

40 Methanol Loss 16 Fugitive Loss

Camphour sulphonyl chloride

15 Methanol to water 60 To Wastewater

Acetic acid 600 Methanol to Residue 24 Solvent in Residue Ethanol 2000 MDC Recovered 5198.4 Recovery & reuse Sodium hydroxide 150 MDC Loss 43.8 Fugitive Loss Acetone 3000 MDC to Residue 229.8 Solvent in Residue Methanol 2000 Acetic acid

Recovered 570 Recovery & reuse

Potassium hydroxide 12 Acetic acid Loss 4.8 Fugitive Loss Magnesium chloride 88.4 Acetic acid to water 18 To Wastewater Activated Carbon 30 Acetic acid to

Residue 7.2 Solvent in Residue

Hydrogen Gas 1.9 Ethanol Recovered 1900 Recovery & reuse Water 4833.5 Ethanol Loss 16 Fugitive Loss Hydrochloric acid 136.9 Ethanol to water 26 To Wastewater Ethanol to Residue 58 Solvent in Residue Acetone Recovered 2910 Recovery & reuse Acetone Loss 24 Fugitive Loss Acetone to water 18.9 To Wastewater Acetone to Residue 47.1 Solvent in Residue (±) Omeprazole 37.3 Organic Residue 4-Dimethylamino

pyridine 24 Organic Residue

N,N-Diisopropyl ethylamine

40 Organic Residue

Activated Carbon 30 To Spent carbon Camphour

sulphonyl chloride 15 Organic Residue

Sodium Chloride 219 To waste water Hydrogen 0.2 Let into atmosphere

through water column Potassiumhydroxide 12 To Wastewater Magnesium chloride 10.3 To Wastewater Water 4871.4 To Wastewater Total Input 18724.9 Total Output 18724.9



2.1.8 Process Description of Glimepiride Stage I

N H 2

N NH

O

CH 3

CH 3

OO

SO C H 3

N C O

OS

NH

NH

O

N NH

O

CH 3

CH 3

O

C H 3O

+

T r a n s - 4 - m e t h y lc y c lo h e x y l i s o c y a n a t e

G l i m e p i r i d e ( P h a r m a )

P o t a s s iu m c a r b o n a t e

4 - [ 2 - ( 3 - e t h y l - 4 - m e t h y l - 2 - o x o - 3 - p y r r o l in e -1 - c a r b o x a m id o ) e t h y l ] b e n z e n e s u l f o n a m id e

T e t r a b u t y l A m m o n iu mB r o m id e

M . W t : 3 5 1 M . W t : 1 3 9

M . W t : 4 9 0 Process Description: Stage- I: 4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] benzene

sulfonamide is condensed with Trans-4-methylcyclohexylisocyanate in presence of Tetra

butyl Ammonium Bromide to yield Glimipride (Pharma). Process flow diagram is

represented in Fig 2.8.Material balance is presented in Table 2.11.

M e t h a n o l

W a t e r

W a s t e W a t e r

T r a n s - 4 - M e t h y l c y c l o h e x y l i s o c y a n a t e

4 - [ 2 - ( 3 - e t h y l - 4 - m e t h y l - 2 - o x o - 3 - p y r r o l i n e -1 - c a r b o x a m i d o ) e t h y l ] b e n z e n e s u l f o n a m i d e

A c e t o n e

A c e t i c a c i d

T e t r a b u t y l a m m o n i u m b r o m i d e

P o t a s s i u m c a r b o n a t e

D i m e t h y l f o r m a m i d e

M e t h y l i s o b u t y l k e t o n e

C e l i t e

G l i m e p r i d e ( P h a r m a )

C o n d e n s a t i o n

M e t h a n o l

A c e t o n e

A c e t i c a c i d

D i m e t h y l f o r m a m i d e

M e t h y l i s o b u t y l k e t o n e

Fig 2.8 Process Flow Diagram of Glimepiride



Table 2.11 Material Balance for Glimepiride Input Quantity


(Kg/day) Remarks

4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]benzene sulfonamide

145.8 Glimepiride 166.7 Final product

Trans-4-methylcyclohexyl isocyanate

57.7 Acetone recovered 1176 Recovered and reused

Tetra butyl Ammonium Bromide (TBAB)

18 Acetone loss 6 Fugitive loss

Acetic acid 20 Acetone to wastewater 4.2 To Wastewater Acetone 1200 Acetone residue 13.8 Solvent in Residue Dimethyl formamide(DMF)

500 DMF recovered 482.5 Recovered and reused

Methanol 400 DMF loss 3 Fugitive loss Potassium carbonate 32 DMF to wastewater 2.5 To Wastewater Methyl Isobutyl Ketone(MIBK)

200 DMF residue 12 Solvent in Residue

Activated carbon 10 Methanol recovered 392 Recovered and reused DM water 1200 Methanol loss 2 Fugitive loss Methanol to wastewater 1.4 To Wastewater Methanol residue 4.6 Solvent in Residue MIBK recovered 194 Recovered and reused MIBK loss 1.4 Fugitive loss MIBK residue 4.6 Solvent in Residue 4-[2-(3-ethyl-4-methyl-2-

oxo-3-pyrroline-1-carboxamido) ethyl] benzene sulfonamide


Trans-4-methyl cyclohexyl isocyanate


TBAB 18 Organic residue Acetic acid 20 To Wastewater Activated carbon 10 To Spent carbon Potassium carbonate 32 To Wastewater Water 1200 To Wastewater Total Input 3783.5 Total Output 3783.5



2.1.9 Process Description of Mesalamine Reaction Schemes

Stage I


Stage – I: Aniline reacts with Sodium nitrite in the presence of salicylic acid to form 5-

Phenylazosalicylicacid. 5-Phenylazosalicylicacid reacts with Sodium Hydrosulfide to form

Mesalamine.Process flow diagram presented in Fig 2.9.Material balance presented in Table

2.12.

Fig 2.9 Process Flow Diagram of Mesalamine



Table 2.12 Material Balance for Mesalamine

Input Quantity (Kg/day)

Output Quantity (Kg/day)

Remarks

Aniline 129 Mesalamine 166.7 Final Product Sodium Nitrite 95 Aniline 101.4 Organic residue Hydro Chloric acid 151 Nasulfo chloride 197.2 To waste water Salicylic acid 191 Sodium chloride 63.7 To waste water Sodium Hydro sulfide 155 Aniline 27.3 Organic residue Carbon 20 Salicylic acid 40 To wastewater Water 3600 Carbon 20 To spent carbon Sodium hydroxide 35 Sodium Hydro sulfide 32.8 To Wastewater Water 3655 To Wastewater Sodium Chloride 51.4 To Wastewater Sodium Nitrite 20.2 Inorganic residue Total Input 4376.4 Total Output 4376.4

2.1.10 Process Description of Metoprolol Succinate Reaction Schemes

Stage I

OHO

OO

O

+

OCl

M.Wt: 152.19

M.Wt: 208.25

M. Wt: 92.52

+ NaClNaOH

M. Wt: 58.44

H2O

M. Wt: 18.02

+

+

M. Wt: 40.00

Stage II

M. Wt: 267.36

NH2

M. Wt: 59.11

Metoprolol

OO

O

M.Wt: 208.25

OO OH

NH

Stage III

OO OH

NH

OO OH

NH

2

COOHCH2CH2COOH

M. Wt: 652.81

Metoprolol

Metaprolol Succinate (pharma)

COOHCH2CH2COOH

M. Wt: 118.09M. Wt: 267.36




Stage-I: The 4-(2-methoxyethyl) phenol and epichlorohydrin are mixed in aqueous media

like water are taken into a reactor. To this mixture 25% w/v sodium hydroxide is added. At

the end of the reaction, the aqueous and organic phases are separated out. The organic

phase is washed thrice by water.

Stage-II: The epoxide and isopropyl amine mixture is 2:1 volume: weight, is reacted in

aqueous media. On completion of reaction, the reaction mixture is cooled. The product is

then extracted using 3 volumes of toluene. The Toluene layer is washed with water for

removal of Isopropyl amine. The Toluene is distilled out at temperature 30 to 40° C. under

vacuum. The residue of Metoprolol base so obtained shows a purity of greater than 99%.

Stage-III: The metoprolol base is dissolved in Acetone. Succinic acid solution is added to

Metoprolol base solution and refluxed. After refluxing, the mixture is then cooled to obtain

metoprolol succinate salt, which is purified by crystallization from three volumes of

Methanol. Process flow diagram of metoprolol succinate is shown in Fig 2.10 and material

balance for metoprolol succinate is presented in Table 2.13.



Fig 2.10 Process Flow Diagram of Metoprolol Succinate



Table 2.13 Material Balance for Metoprolol Succinate Stage I Input Quantity


(Kg/day) Remarks

4-(2-Methoxy-ethyl)-phenol

267.6 2-[4-(2-Methoxy-ethyl)-phenoxymethyl]-oxirane

357.4 To Stage-II

2-Chloromethyl-oxirane

162.7 Sodium chloride 102.8 To wastewater

Sodium hydroxide 70.3 4-(2-Methoxy-ethyl)-phenol

6.4 Organic residue

Water 2000 2-Chloromethyl-oxirane 3.9 Organic residue Hydrochloric acid 2 Sodium chloride 2.5 To wastewater Water 2031.7 To wastewater Total Input 2502.2 Total Output 2502.2 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 357.4 Metoprolol 445.1 To Stage-III Isopropyl amine 101.5 Toluene Recovered 970 Recovery & reuse Toluene 1000 Toluene Loss 3 Fugitive Loss Water 1300 Toluene to wastewater 5.2 To Wastewaetr Toluene to Residue 21.8 Solvent in Residue Stage I Product 10.7 Organic residue Isopropyl amine 3 Organic residue Water 1300 To wastewater Total Input 2758.9 Total Output 2758.9 Stage III Input Quantity


(Kg/day) Remarks

Metoprolol 445.1 Metoprolol Succinate 500 Final Product Succinic acid 98.4 Acetone Recovered 2425 Recovery & reuse Acetone 2500 Acetone Loss 12.5 Fugitive Loss Acetone in residue 63 Solvent in residue Metoprolol 35.61 Organic residue Succinic acid 7.87 Organic residue Total Input 3043.5 Total Output 3043.5



2.1.11 Process Description of Pantoprazole sodium sesquihydrate

Reaction Schemes

NH

NO

FF

S CH 2

N

O C H 3C H 3 O

NN

NO

FF

SOM e O

O M e

E t h a n o l

5 - ( D i f l u o r o m e t h o x y ) - 2 - [ [ ( 3 , 4 - d im e t h o x y - 2 -p y r i d in y l ) m e t h y l ] t h i o ] - 1 H - b e n z im id a z o le

+ S o d iu m h y p o c h lo r i t e

2 H 2 O+ +

N a O C l N a O H

M . W t : 3 6 7

M . W t : 7 4 . 5M . W t : 4 0 M . W t : 3 6

-+N a

. 1 . 5 H 2 O

P a n t o p r a z o l e s o d i u m s e s q u i h y d r a t e ( P h a r m a )

N a C l+

1 . 5 H 2 O

M . W t : 2 7M . W t : 5 8 . 5+

M . W t : 4 3 2

D i i s o p r o p y l e t h e r


Stage I 5-(Difluoromethoxy)-2-[[3,4-dimethoxy-2-pyridinyl)methyl]thio]-1H-benzimidazole(Stage-I

compound) is Oxidised with Sodium Hypochlorite, then reacted with Sodium hydroxide

and water in presence of Methylene dichloride and Diisopropyl ether to give Pantoprazole

sodium sesquihydrate (Pharma). Process flow diagram Presented in Fig 2.11.Material

balance presented in Table 2.14.

O x id a t io n & S a lt i f ic a t io n

S o d iu m h y p o c h lo r ite


N a C l

W a s te w a te r

P a n to p r a z o le S o d iu m S e s q u ih y d r a te (P h a r m a )


D iis o p r o p y l e th e r

A c tiv a te d c a r b o n A c tiv a te d c a r b o n

A c e to n e

W a te r

S o d iu m h y d r o x id e ly e

D iis o p r o p y l e th e r

A c e to n e

A m m o n iu m s u lp h a te

E th a n o l

E th a n o l

5 - ( D if lu o r o m e th o x y ) -2 - [ [ 3 ,4 -d im e th o x y -2 - p y r id in y l)m e th y lth io ] - 1 H -b e n z im id a z o le

Fig 2.11 Process Flow Diagram of Pantoprazole sodium Sesquihydrate



Table 2.14 Material Balance for Pantoprazole Sodium Sesquihydrate Input Quantity


(Kg/day) Remarks

5-(Difluoromethoxy)-2-[[3,4-dimethoxy-2-pyridinyl) methyl]thio]-1H-benzimidazole

459.2 Pantoprazole Sodium Sesquihydrate

500 Final Product

Sodium hypochlorite (8%) 1165.2 Acetone Recovered 873 Recovery & reuse Sodium hydroxide flakes 200.1 Acetone Loss 7.2 Fugitive Loss Ammonium sulphate 250 Acetone to water 5.7 To Wastewater Diisopropyl ether (DiPE) 1500 Acetone to Residue 14.1 Solvent in Residue Ethanol 1200 Ethanol Recovered 1164 Recovery & reuse Activated carbon 30 Ethanol Loss 9.6 Fugitive Loss Acetone 900 Ethanol to water 7.6 To Wastewater Water 3445 Ethanol to Residue 18.8 Solvent in Residue Methlene Dichloride (MDC)

250 MDC Recovered 237.5 Recovery & reuse

Hydrochloric acid 140.3 MDC Loss 2 Fugitive Loss MDC to water 0.8 To Wastewater MDC to Residue 9.7 Solvent in Residue DiPE Recovered 1452 Recovery & reuse DiPE Loss 12 Fugitive Loss DiPE to water 12.5 To Wastewater DiPE to Residue 23.6 Solvent in Residue Organic Impurities 34.4 Organic residue Activated carbon 30 To spent carbon Sodium hypochlorite 7 To Wastewater Ammonium sulphate 250 Inorganic Residue Sodium chloride 292.6 To Wastewater Water 4544.6 To Wastewater Total Input 9539.3 Total Output 9539.3



2.1.12 Process Description of Pragabalin

Reaction Schemes

Stage I

OH

OCONH2

OH

ONH2

+NaCl

3-(Carbamoylmethyl)-5-methylhexanoic acid

Pregabalin Sodium chloride

M.Wt 159 M.Wt 187

M.Wt: 58.5

H2CO3

Carbonic acidM.Wt 62

+NaOCl

M.Wt 74.5

++ H2O

WaterM.Wt 18

Sodium hypochlorite

Chloroform


3-(Carbamoylmethyl)-5-methylhexanoic acid is reacted with sodium hypochlorite to give

Pregabalin (Pharma). The process flow diagram is presented in fig 2.12. The material balance

is shown in Table 2.15.

Water

Pregabalin(Pharma)

Waste water


Chloroform

Phenylethylamine

Hydrochloric acidSodium hydroxide

Isopropyl alcohol

Sodium hypochlorite

Chloroform

Isopropyl alcohol

Carbonic acid

Sodium chloride

Fig 2.12 Process Flow Diagram of Pragabalin



Table 2.15 Material Balance for Pragabalin Input Quantity


(Kg/day) Remarks


817.9 Pregabalin 500 Final Product

Phenylethylamine 75 Carbonic acid 195 To wastewater Sodium hypochlorite 325.8 Sodium chloride 184 To wastewater Hydrochloric acid 20 IPA Recovered 1900 Recovery & reuse Sodium hydroxide 21.9 IPA Loss 16 Fugitive Loss Isopropanol (IPA) 2000 IPA to water 60 To Wastewater Chloroform 4000 IPA to Residue 24 Solvent in Residue Water 78.7 Chloroform Recovered 3800 Recovery & reuse Water 3500 Chloroform Loss 32 Fugitive Loss Chloroform to water 120 To Wastewater Chloroform to Residue 48 Solvent in Residue 3-(Carbamoylmethyl)-5-

methylhexanoic acid 229.8 Organic residue

Phenylethylamine 75 Organic residue Sodium hypochlorite 92 To Wastewater Sodium chloride 32.1 To Wastewater Water 3532 To Wastewater Total Input 10839.4 Total Output 10839.4

2.1.13 Process Description of Rosuvastatin Calcium

Reaction Schemes

Stage I

N

N

C H 3CH 3

NS

C H 3

CH 3

O O

O O H

F

C O O M e

N

N

C H 3CH 3

NS

C H 3

CH 3

O O

O H

F

O H

O

O

2

+

(R ) -7 - [4 - (4 -F lu o ro p h e n y l) -6 - (1 -m e th y le th y l) -2 -[m e th y l(m e th y ls u lfo n y l)a m in o ] -5 -p y r im id in y l ] -3 -h y d ro x y -5 -o x o -6 -h e p te n o ic a c id m e th y l e s te r

2 N a B H 4

+6 H 2 O

E th y l a c e ta te2 N a B O 3

8 H 2

W a te r

+2 N a O H

S o d iu m H y d ro x id e

A c e to n e

2 N a O C H 3

S o d iu m m e th o x id e

M .W t: 1 0 8

M .W t: 8 0

M .W t: 1 6 2

S o d iu m p e rb o r a te

M .W t: 1 6

M .W t: 9 8 7

M .W t: 7 4

S o id u m b o ro h y d r id e M .W t: 1 0 8+

C a (O C O C H 3 ) 2

C a 2 +E th a n o l

+

2 C H 3 C O O H

R o s u v a s t a t in C a lc iu m ( P h a rm a )

C a lc iu m a c e ta te

A c e t ic a c id

M .W t: 1 5 8

M .W t: 1 0 0 1

M .W t: 1 2 0

2 .




(R)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidin

yl]- 5-pyrimidinyl]-3-hydroxy-5-oxo-6-heptenoic acid methyl ester is reduced by using

sodiumborohydride, followed by hydrolised with sodium hydroxide in acetone and water

and then treated with calcium acetate in ethanol to yield Rosuvastatin calcium (Pharma).

The process flow diagram for Rosuvastatin calcium is presented in Fig 2.13 .Material balance

is presented in Table 2.16.

W ater

W astewater

(R)-7-[4-(4-Fluorophenyl)-6-(1-m ethylethyl)-2-[m ethyl(m ethylsulfonyl)am ino]-5-pyrim idinyl]-3-hydroxy-5-oxo-6-heptenoic acid m ethyl ester

Ethyl acetate

W ater

Sodium Hydroxide

Acetone

Sodium m ethoxide

Sodium perborateSoidum borohydride

Ethanol

Rosuvastatin Calcium (Pharm a)

Calcium acetate

Acetic acid

Activated Carbon

Ethyl acetate

Acetone

Ethanol

Activated Carbon

Fig 2.13 Process Flow Diagram of Rosuvastatin Calcium



Table 2.16 Material Balance for Rosuvastatin Calcium Input Quantity


(Kg/day) Remarks

(R)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-5-pyrimidinyl]-3-hydroxy-5-oxo-6-heptenoic acid methyl ester

114.7 Rosuvastatin Calcium 100 Final Product

Sodium borohydride 8.6 Sodium Methoxide 10.8 Organic residue Sodium hydroxide 9.3 Sodium Perborate 16.2 To wastewater Water 12.5 Acetic acid 12 To Wastewater Acetone 750 Hydrogen 1.6 Let out into


Ethyl acetate 1000 Acetone Recovered 720 Recovery & reuse Activated carbon 25 Acetone Loss 6 Fugitive Loss Calcium acetate 18.4 Acetone to wastewater 5.5 To Wastewater Ethanol 800 Acetone to Residue 18.5 Solvent in Residue Water 1100 Ethyl acetate Recovered 980.0 Recovery & reuse Hydrochloric acid 1.2 Ethyl acetate Loss 8.0 Fugitive Loss Ethyl acetate to

wastewater 9.3 To Wastewater

Ethyl acetate to Residue 2.7 Solvent in Residue Ethanol Recovered 768 Recovery & reuse Ethanol Loss 6.4 Fugitive Loss Ethanol to wastewater 6.6 To Wastewater Ethanol to Residue 19 Solvent in Residue (R)-7-[4-(4-Fluorophenyl)-

6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-5-pyrimidinyl]-3-hydroxy-5-oxo-6-heptenoic acid methyl ester


Activated carbon 25 To spent carbon Calcium acetate 2.6 To Wastewater Sodium borohydride 1.2 To Wastewater Sodium Chloride 1.9 To Wastewater Water 1102.3 To Wastewater Total Input 3839.6 Total Output 3839.6



2.1.14 Process Description of Sertraline HCl

Reaction Schemes

Stage I N

C l

C l

C H 3

C lC l

N H - C H 34 - ( 3 ,4 - D ic h lo r o p h e n y l) - 3 ,4 -d ih y d r o - N - m e th y l- 1 ( 2 H ) -N a p h th a le n im in e

D - ( - ) M a n d e l ic a c id

M .W t :3 0 4

.H C l

S e r t r a l in e H y d r o c h lo r id e ( P h a r m a )

M .W t :3 4 2 .5

N a B H 4

H C lM .W t :3 6 .5

+ +4 C H 3 O H

S o d iu m B o r o h y d r id e

M .W t : 3 8

M e th a n o l

M .W t : 1 2 8

+B ( O C H 3 ) 3

+T r im e th o x y b o r a n e

N a O C H 3

S o d iu mM e th o x id e

+ 3 H 2

M .W t : 5 4M .W t : 6

M .W t : 1 0 4


4-(3,4-Dichlorophenyl)-3,4-dihydro-N-methyl-1(2H)-Naphthalenimine is hydrogenated with

sodium borohydride followed by resolution with D-(-) Mandelic acid and then treated with

Hydrochloric acid to give Sertraline hydrochloride (Pharma). Process flow diagram is

presented in Fig 2.14.Material balance is presented in Table 2.17.

Sertraline HCl (Pharma)

Sodium borohydride

Activated carbon

Activated carbon

Reduction

Resolution

4-(3,4-Dichlorophenyl)-3,4-dihydro-N-methyl-1(2H)-Naphthalenimine

Methanol

HCl

Water

Diisopropyl Ether

Ethyl acetate

D-(-)-Mandelic acid

n-Butanol

Waste water

NaOH

NaCl

&

Trimethyl borate

Sodium methoxide

H2

Fig 2.14 Process Flow Diagram of Sertraline HCl



Table 2.17 Material Balance for Sertraline HCl Input Quantity


(Kg/day) Remarks

4-(3,4-Dichlorophenyl)-3,4-dihydro-N-methyl-1(2H)-Naphthalenimine

378.8 Sertraline Hydrochloride 333.3 Final Product

Sodium Borohydride 47.3 Trimethoxy Borane 101.2 To wastewater Methanol 159.5 Sodium methoxide 52.5 Carried with

methanol in Organic residue

Hydrochloric acid 45.5 Hydrogen 5.8 Let out into atmosphere

Ethyl acetate 3000 Ethyl acetate Recovered 2850 Recovery & reuse Activated carbon 20 Ethyl acetate Loss 24 Fugitive Loss D-(-)-Mandelic acid 85 Ethyl acetate to water 90 To Wastewater Sodium hydroxide lye 10.9 Ethyl acetate to Residue 36 Solvent in Residue Water 3500 n-Butanol Recovered 1425 Recovery & reuse n-Butanol 1500 n-Butanol Loss 12 Fugitive Loss Diisopropyl ether (DiPE)

650 n-Butanol to water 45 To Wastewater

n-Butanol to Residue 18 Solvent in Residue DiPE Recovered 617.5 Recovery & reuse DiPE Loss 5.2 Fugitive Loss DiPE to water 19.5 To Wastewater DiPE to Residue 7.8 Solvent in Residue 4-(3,4-Dichlorophenyl)-

3,4-dihydro-N-methyl-1(2H)-Naphthalenimine

83 Organic residue

Activated carbon 20.0 To spent carbon D-(-)-Mandelic acid 85 To waste water Methanol 35 To Organic Waste Sodium Borohydride 10.4 To Wastewater Sodium chloride 16 To Wastewater Water 3504.9 To Wastewater Total Input 9397.0 Total Output 9397.0



2.1.15 Process Description of Tramadol Hydrochloride Reaction Schemes

Stage I

Process Description: Stage I

2-[(N,N-Dimethylamino)methyl]cyclohexanone is reacted with Bromo (3-methoxy phenyl)

magnesium in presence of Sodium carbonate in Ethyl acetate, n-Propanol and water to yield

Tramadol Hydrochloride (Pharma). The process flow diagram for Tramadol Hydrochloride

is presented in Fig 2.15.Material balance is presented in Table 2.18.

Fig 2.15 Process Flow Diagram of Tramadol Hydrochloride



Table 2.18 Material Balance for Tramadol Hydrochloride Input Quantity


(Kg/day) Remarks

2-[(N,N-Dimethylamino) methyl] cyclohexanone

461.9 Tramadol HCl 666.7 Final Product

Bromo(3-methoxyphenyl) magnesium

628.8 Hydroxy MgBr 269.4 Inorganic residue

Sodium carbonate 170 n-Propanol Recovered 2850 Recovery & reuse Ethyl acetate 3500 n-Propanol Loss 24 Fugitive Loss Hydrochloric acid 258.8 n-Propanol to water 90 To Wastewater n-Propanol 3000 n-Propanol to Residue 36 Solvent in Residue Activated carbon 30 Ethyl acetate Recovered 3325 Recovery & reuse Water 53.6 Ethyl acetate Loss 28 Fugitive Loss Water 6000 Ethyl acetate to water 105 To Wastewater Sodium Hydroxide 194.5 Ethyl acetate to Residue 42 Solvent in Residue 2-[(N,N-Dimethyl

amino) methyl] cyclohexanone


Activated carbon 30 To spent carbon Bromo(3-methoxy

phenyl) magnesium 159 Organic residue

Sodium chloride 285 To Wastewater Sodium carbonate 170 To Wastewater Water 6101.1 To Wastewater Total Input 14297.6 Total Output 14297.6



2.1.16 Process Description of Valaciclovir Hydrochloride monohydrate

Reaction Schemes

Stage I

NH

N

O

A c H N N

N

OO A c C H 3

NH O O C

CH 3

O

OP h

NH

N

O

NH 2N

N

OO C H 3

ONH P h

O

C H 3O

2 -(A c e ty la m in o ) -1 ,9 -d ih yd ro -9 -[[2 - (a c e ty lo x y)e th o x y ]m e th y l]-6 H -p u r in -6 -o n e

C a rb o b e n z y lo x y -L -v a lin e

+

2 - [(2 -A m in o -1 ,6 -d ih yd ro -6 -o x o -9 H -p u r in -9 -y l)m e th o x y ]e th y l N - [(b e n zy lo x y)c a rb o n y l] L -v a lin e

4 0 % D im e th y l a m in e

D im e th y l fo rm a m id e4 -D im e th y la m in o p y r id in e1 ,3 -D ic yc lo h e x y l c a rb o d im id e

2 C H 3 C O O H+M .W t: 1 2 0

M .W t: 3 0 9

M .W t: 2 5 1

M .W t: 4 5 8

W a te r (1 8 )

Stage II

NH

N

O

NH 2N

N

OO C H 3

ONH P h

O

C H 3O

NH

N

O

NH 2N

N

OO C H 3

C H 3O

N H 2

.H Cl .H 2 O

C O O HP h

2-[(2 -A m ino -1 ,6 -d ihyd ro -6 -oxo -9H -pu rin -9 -yl)m e thoxy]e thyl N -[(benzyloxy)ca rbonyl] L -va line

V a lc ic lo v ir H yd ro ch lo rid e m o n o h yd ra te (P h arm a)

H 2, P d /CH C l H 2O+ +

M .W t: 458

M .W t: 36 .5 M .W t: 18

+

M .W t: 136

M .W t: 378 .5

P henylace tic ac id

M .W t: 2

Process Description

Stage-I: 2-(Acetylamino)-1,9-dihydro-9-[[2-(acetyloxy)ethoxy]methyl]-6H-purin-6-one

condensed with carbobenzyloxy–L–valine in the presence of 40% Dimethyl

amine,Dimethylformamide, 4-Dimethylamino pyridine and 1, 3-Dicyclohexyl carbodimide



to yield 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl N-

[(benzyloxy)carbonyl] L-valine (Stage-I compound).

Stage-II: 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethylN-[(benzyloxy)

carbonyl] L-valine is reduced with H2 using palladium on carbon as catalysed and further

reacted with Hydrochloric acid and water to yield Valaciclovir Hydrochloride

Monohydrate (Pharma). Processw flow diagram is presented in Fig 2.16.Material balance is

presented in Table 2.19.

STAGE-IIWater

Valcyclovir Hydrocloride Monohydrate (Pharma)

STAGE-I

2-(Acetylamino)-1,9-dihydro-9-[[2-(acetyloxy)ethoxy]methyl]-6H-purin-6-one

Carbobenzyloxy-L-ValineDimethyl amine

Dimethyl formamide

4-Dimethylamino pyridine1,3-Dicyclohexyl carbodimide

AcetoneWater

Hyflo super cel

Ethanol

Condensation

Acetic acidDimethylDimethyl formamide

1,3-Dicyclohexyl carbodimideAcetone

4-Dimethylamino pyridine

WastewaterHyflo super celEthanol

2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl]N-[(benzyloxy)carbonyl] L-valine

2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl]N-[(benzyloxy)carbonyl] L-valine

Palladium on carbon

Hydrochloric acid

Methanol

Ethanol

Phenylacetic acid

Palladium on carbon

Wastewater

Methanol

Ethanol

Reduction

Hydrogen gas

Sodium hydroxide

Fig 2.16 Process Flow Diagram of Valaciclovir Hydrochloride monohydrate



Table 2.19 Material Balance for Valaciclovir Hydrochloride Monohydrate Stage I Input Quantity


(Kg/day) Remarks

2-(Acetylamino)-1,9-dihydro-9-[[2-(acetyloxy)ethoxy] methyl]-6H-purin-6-one

494.4 Stage I Product 669.72 Stage II Product

Carbenzyloxy-L-Valine 402 Acetic acid 175.5 To Wastewater Dimethyl amine (DMA) 2500 DMA Recovered 2437.5 Recoverd & Reused Dimethyl formamide (DMF)

350 DMA Loss 12.5 Fugitive Loss


20 DMA to Wastewater 25 To Wastewater

1,3-Dicyclohexyl carbodiimide

100 DMA to Residue 25 Solvent in Residue

Acetone 2500 DMF Recovered 339.3 Recoverd & Reused Water 29 DMF Loss 1.4 Fugitive Loss Hyflo super cel 15 DMF to Residue 9.1 Solvent in Residue Ethanol 3000 Acetone Recovered 2437.5 Recoverd & Reused Sodium hydroxide 150 Acetone Loss 10 Fugitive Loss Water 2500 Acetone to Residue 52.5 Solvent in Residue Hydrochloric acid 136.9 Ethanol Recovered 2925 Recoverd & Reused Ethanol Loss 12 Fugitive Loss Ethanol to Residue 63 Solvent in Residue 2-(Acetylamino)-1,9-

dihydro-9-[[2-(acetyloxy)ethoxy] methyl]-6H-purin-6-one


Carbenzyloxy-L-Valine 34.6 Organic Residue 4-Dimethylamino

pyridine 20 Organic Residue

1,3-Dicyclohexyl carbodiimide

100 Organic Residue

Sodium chloride 219.2 To Wastewater Hyflo super cel 15 Inorganic residue Water 2570 To Wastewater Total Input 12196.5 Total Output 12196.5



Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 669.7 Valcyclovir Hydrochloride Monohydrate

333.3 Final Product

Palladium on carbon 30 Phenyl acetic acid 119.8 To Wastewater Water 26.3 Methanol Recovered 1447.5 Recoverd & Reused Hydrochloric acid 53.4 Methanol Loss 7.5 Fugitive Loss Methanol 1500 Methanol to

Wastewater 15 To Wastewater

Ethanol 2500 Methanol to Residue 30 Solvent in Residue Hydrogen 2.9 Ethanol Recovered 2412.5 Recoverd & Reused Activated Carbon 25 Ethanol Loss 12.5 Fugitive Loss Water 3000 Ethanol to Wastewater 20 To Wastewater Sodium Hydroxide 23.3 Ethanol to Residue 55 Solvent in Residue Stage I Product 266.4 Organic Residue Activated Carbon 25 To spent carbon Palladium on carbon 30 To spent catalyst water 3021 To waste water Hydrogen 1.2 Let out into

atmosphere Sodium Chloride 34 To waste water Total Input 7830.6 Total Output 7830.6



2.1.17 Process Description of 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid

methyl ester

Reaction Schemes

Stage I

Stage II

Stage III



Process Description

Stage-I: 2-methyl-2-phenyl propan-1-ol reacts with acetyl chloride in presence of sodium

acetate AlCl3, DMF and toluene to give Acetic acid 2-methyl-allyl ester (Stage-I compound).

Stage-II: Acetic acid 2-methyl-2-phenyl-propyl ester is react with 4- chloro butyryl chloride

in presence of AlCl3 to give Acetic 2-[4-(4-chloro-butyryl)-phenyl]-2-methyl-propyl ester.

Further this is react with NaOH to give Cyclopropyl-[4-(2-hydroxy-1, 1-dimethyl-ethyl)-

phenyl]-methanone (Stage-II compound).

Stage-III: Cyclopropyl-[4-(2-hydroxy-1, 1-dimethyl-ethyl)-phenyl]-methanone is react with

KMO4 to give 2-(4-Cyclopropanecarbonyl-phenyl)-2-methyl-propionoc acid. Further this is

reacting with Methanol and HCl to give 4- (4-Chloro-1-oxobutyl) 2, 2-dimethylphenyl acetic

acid methyl ester (Stage-III compound). The process flow diagram for give 4- (4-Chloro-1-

oxobutyl) 2, 2-dimethylphenyl acetic acid methyl ester is presented in Fig 2.17. And

material balance is presented in Table 2.20.



Fig 2.17 Process Flow Diagram of 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid

methyl ester



Table 2.20 Material Balance for 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid methyl ester

Stage I Input Quantity


(Kg/day) Remarks

2-methyl-2-phenyl propan-1-ol


Acetyl chloride 64 DMF Recovered 232 Recovery & reuse Sodium acetate 65 DMF Loss 0.5 Fugitive Loss DMF 241.5 DMF to Wastewater 2.4 To wastewater Toluene 400 DMF to Residue 6.8 Solvent in Residue Water 2500 Toluene Recovered 384 Recovery & reuse Aluminium chloride 85 Toluene Loss 0.8 Fugitive Loss 5 % sodium bi carbonate 100 Toluene to Wastewater 4 To wastewater Sodium Hydroxide 25.5 Toluene to Residue 11.2 Solvent in Residue 2-methyl-2-phenyl

propan-1-ol 26.8 Organic residue

Acetyl chloride 14 Organic residue Sodium acetate 65 To wastewater Aluminium chloride 85 To wastewater Sodium bi carbonate 5 To wastewater Sodium chloride 37.2 To wastewater Water 2606.5 To wastewater Total Input 3603.6 Total Output 3603.6 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 122.6 Stage II Product 111.1 To Stage-III 4-chloro butyryl chloride 89.9 Aluminium chloride 68 To Waste water Aluminium chloride 85 Acetic acid 30.9 To Waste water Sodium hydroxide flakes 25.5 Sodium chloride 29.8 To Waste water Methylene dichloride (MDC)

800.0 MDC Recovered 776 Recovery & reuse

Diluted Hcl 4.7 MDC Loss 2 Fugitive Loss Methanol 600 MDC to Residue 22 Solvent in Residue 5 % sodium bi carbonate 100 Toluene Recovered 533.5 Recovery & reuse Toluene 550 Toluene Loss 1.4 Fugitive Loss Water 1500 Toluene to Residue 15.1 Solvent in Residue Methanol Recovered 582 Recovery & reuse Methanol Loss 1.5 Fugitive Loss Methanol to Residue 16.5 Solvent in Residue Stage I Product 24.5 Organic residue 4-chloro butyryl

chloride 18 Inorganic residue

Aluminium chloride 17 To Waste water Sodium Chloride 7.5 To Waste water



Sodium bi carbonate 5 To Waste water Water 1597.3 To Waste water Total Input 3877.6 Total Output 3877.7 Stage III Input Quantity


(Kg/day) Remarks

Stage II Product 111.1 4-(4-Chloro-1-oxobutyl)2,2-dimethyl phenyl acetic acid methyl ester

100 Final Product

Potassium Permanganate 80.4 Potassium Manganite 44.6 Inorganic residue MDC Recovered 145.5 Recovery & reuse Methanolic HCl 35 MDC Loss 0.4 Fugitive Loss Sodium hydroxide flakes 95 MDC to Residue 4.1 Solvent in Residue Con. Hydrochloric acid 86.7 Toluene Recovered 679.0 Recovery & reuse Sodium meta bisulfite 40 Toluene Loss 1.8 Fugitive Loss 10% C. lye solution 200 Toluene to Residue 19.3 Solvent in Residue Methylene dihloride (MDC)

150 Stage II Product 33.9 Organic residue

Toluene 700 Methanolic HCl 10.6 To waste water Water 2500 Potassium

Permanganate 24.5 To waste water

Sodium chloride 138.8 To waste water Sodium meta bisulfite 40 Inorganic residue Water 2735.5 To waste water Total Input 3998.1 Total Output 39998.1



2.1.18 Process Description of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-

L-lysine

Reaction Schemes

Stage I

Stage II

Process Description

Stage-I: L-Lysine is reacted with 2, 2, 2-Trifluoroethylacetate in presence of methanol and

water to give (S)-6-(2, 2, 2-trifluoroacetamido-2-amino hexanoicacid.

Stage-II: (E)-Ethyl-4-oxo-4-phenylbut-2-enoate and (S)-6-(2,2,2-trifluoroacetamido-2-amino

hexanoicacid are reacted in presence of lithium hydroxide and HCl and further reacted with

Pd/C under hydrogen atmosphere in presence of ethanol, ethyl acetate and Water to give

N2-(1-(S)-ethoxycarbonyl-3-phenylpropyl-N6-trifluoro acetyl) -L- Lysine.process flow

diagram is presented in Fig 2.18.Material balance is presented in Table 2.21.



Fig 2.18 Process Flow Diagram of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine



Table 2.21 Material Balance for N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine



(Kg/day) Remarks

L-Lysine 319.5 Stage I Product 303.5 To Stage II Water 1200 Ethanol 57.7 To Wastewater Caustic Lye (40%) 80 Methanol Recovered 2316 Recoverd & Reused 2,2,2-Trifluoroethyl acetate

310.8 Methanol Loss 12 Fugitive Loss

Methanol 2400 Methanol to Wastewater 24 To Wastewater Methanol to Residue 48 Solvent in Residue L-Lysine 136.4 Organic Residue 2,2,2-Trifluoroethylacetate 132.7 Organic Residue Caustic Lye 32 To Waste water Water 1248 To waste water Total Input 4310.3 Total Output 4310.3 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 303.5 N2-(1-(S)-ethoxycarbonyl- 3-phenylpropyl- N6-trifluoro acetyl)- L-Lysine

166.7 Final Product

(S)-6-(2,2,2-trifluoroacetamido-2-amino hexanoicacid

360 Lithium chloride 16.4 To Wastewater

Ethanol 100 Ethyl acetate Recovered 1930 Recoverd & Reused Lithium Hydroxide 35.7 Ethyl acetate Loss 10 Fugitive Loss Hydrochloric acid 54.3 Ethyl acetate to water 12.2 To Wastewater Palladium on catalyst 50 Ethyl acetate to Residue 47.8 Solvent in Residue Water 1500 Ethanol Recovered 97 Recoverd & Reused Ethylacetate 2000 Ethanol Loss 0.4 Fugitive Loss Hydrogen 6 Ethanol to Wastewater 0.5 To Wastewater Caustic Lye (40%) 110.2 Ethanol to Residue 2.1 Solvent in Residue Stage I Product 224.7 Organic Residue (S)-6-(2,2,2-trifluoro

acetamido- 2-amino hexanoicacid


Lithium Hydroxide 26.4 To Wastewater Palladium on catalyst 50 To spent catalyst Hydrogen Gas 4.4 Let out into


Sodium chloride 64.4 To Wastewater Water 1599.8 To Wastewater Total Input 4519.6 Total Output 4519.6



2.1.19 Process Description of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl] phenyl]-3-

hydroxypropyl] phenyl-2-propanol

Reaction Schemes

Stage I

Stage II




Stage–I: 3-[2-(7-chloro-2-quinolinyl)ethenyl]-alpha-[2-(methoxycarbonyl-phenyl)methyl] -

beta-oxo-benzene propanoicacid methyl ester react with hydrochloric acid in presence Of

Acetic acid to give 2-[3-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-

(oxopropyl]benzoicacid and this under goes to reacted with methyl Iodide to gives 2-[3-[3-

[2-(7-chloro-2-quinolinyl)ethenyl]-phenyl]-3-(oxopropyl]benzoic acid methyl ester.

Stage–II: 2-[3-[3-[2-(7-chloro-2- quinolinyl)ethenyl] phenyl]-3-(oxopropyl] benzoic acid

methyl ester react with (-)-beta chlorodiisopinocamphenyl borane and methanol to give (S)-

2-[3-[3-[2-7-chloro-2-quinolinyl)ethenyl] phenyl]-3-hydroxypropyl]benzoic acid methyl ester

and this under goes to reacted with methyl magnesium chloride and water in toluene to

give 2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-hydroxypropyl] phenyl]-2-

propanol.Process Flow diagram presented in Fig 2.19.Material balance presented in Table

2.22.



Fig 2.19 Process Flow Diagram of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl] phenyl]-

3-hydroxypropyl] phenyl-2-propanol



Table 2.22 Material Balance for 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol



(Kg/day) Remarks

3-[2-(7-chloro-2-quinolinyl) ethenyl]-alpha-[2-(methoxy carbonyl-phenyl)methyl] -beta-oxo-benzenepropanoic acid methyl ester


Glacial acetic acid 150 Methanol 16.9 To Wastewater Hydrochloric acid 10.4 Carbon dioxide 11.6 Let out into

atmosphere Methyl iodide 40.1 Hydrogen Iodide 33.8 To Wastewater Saturated ammonium chloride (20%)

600 Methanol Recovered 144.8 Recoverd & Reused

Methylene Dichloride (MDC) 2500 Methanol Loss 0.8 Fugitive Loss Potassium Carbonate 25 Methanol to water 1.5 To Wastewater Methanol 150 Methanol to

Residue 3 Solvent in Residue

Water 1300 MDC Recovered 2412.5 Recoverd & Reused Acetonitrile 400 MDC Loss 12.5 Fugitive Loss Sodium Hydroxide 0.8 MDC to water 5.3 To Wastewater MDC to Residue 69.8 Solvent in Residue Acetonitrile

Recovered 386 Recoverd & Reused

Acetonitrile Loss 2 Fugitive Loss Acetonitrile to water 0.4 To Wastewater Acetonitrile to

Residue 12 Solvent in Residue

3-[2-(7-chloro-2-quinolinyl)ethenyl]-alpha-[2-(methoxy carbonyl-phenyl) methyl] -beta-oxo-benzenepropanoicacid methyl ester


Methyl iodide 2.8 Organic residue Glacial acetic acid 150.0 To Wastewater Ammonium

chloride 120 To Wastewater

Potassium Carbonate

25 To Wastewater

Sodium chloride 1.2 To Wastewater Water 1780.4 To Wastewater Total Input 5322.4 Total Output 5322.4



Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 120.5 2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl) ethenyl]phenyl]-3-hydroxypropyl] phenyl]-2-propanol.

100 Final Product

(-)-beta chlorodiisopino camphenyl borane

84.8 Hydroxy MgCl 16.8 To Wastewater

Methyl magnesium chloride 40.1 Methoxy magnesium chloride

19.8 To Wastewater

Methanol 8.5 (-)-beta Methoxydiisopinocamphenyl borane


Diethanolamine 80 Methanol Recovered 289.5 Recoverd & Reused Cerium chloride 50 Methanol Loss 1.5 Fugitive Loss Ammonium chloride (30%) 600 Methanol to water 3 To Wastewater Toluene 1800 Methanol to Residue 6 Solvent in Residue Hy-flow 50 Toluene Recovered 1746 Recoverd & Reused Hexane 1000 Toluene Loss 7.2 Fugitive Loss Water 4.76 Toluene to water 9 To Wastewater Methanol 300 Toluene to Residue 37.8 Solvent in Residue Water 3000 Hexane Recovered 970 Recoverd & Reused Sodium Hydroxide 8.7 Hexane Loss 4 Fugitive Loss Hexane to water 5 To Wastewater Hexane to Residue 21 Solvent in Residue Stage I Product 20.9 Organic Residue (-)-beta

chlorodiisopinocamphenyl borane


Methyl magnesium chloride

7 To Wastewater

Methanol 1.5 To Wastewater Diethanolamine 80 To Wastewater Cerium chloride 50 To Wastewater Ammonium

chloride 180 To Wastewater

Hy-flow 50 Inorganic residue Sodium chloride 12.8 To Wastewater Water 3424.8 To Wastewater Total Input 7147.3 Total Output 7147.3



2.1.20 Process Description of 2, 8-Diazo bicyclo Nonane Reaction Schemes Stage I

Stage II

Stage III



Stage IV


Stage-I: 2,3-Pyridine Dicarboxylic acid reacts with Acetic anhydride to form furo[3,4-

b]pyridine-5,7-dione and further reacts with Benzyl amine to form (3-

benzylcarbamoyl)picolinic acid (Stage-I compound).

Stage-II: (3-benzylcarbamoyl)picolinic acid is cyclization with 6-Benzyl-5H-pyrrol[3,4-

b]pyridine-5,7-(6H)dione and further undergoes reduction with Pd/C in presence of ethyl

acetate to form 6-Benzylhexahydro-5H-pyrrol[3,4-b]pyridine-5,7-(6H)dione (Stage-II

compound).

Stage -III: 6-Benzylhexahydro-5H-pyrrol[3,4-b]pyridine-5,7-(6H)dione undergoes reduction

to form 6-Benzyltetrahydro-5H-pyrrol[3,4-b]pyridine-5,7-(6H)dione and further reacts with

AlCl3 and SBH to form 6-Benzyloctahydro-1H-pyrrol[3,4-b]-pyridine (Stage-III compound).

Stage -IV: 6-Benzyloctahydro-1H-pyrrol [3, 4-b]-pyridine undergoes reduction with Pd/C

to form (s,s)-2,8-diazabicyclo[4.3.0]nonane (Stage-IV compound). The process flow diagram

(s,s)-2,8-diazabicyclo[4.3.0]nonane is presented in Fig 2.20.And material balance is presented

in Table 2.23.



Fig 2.20 Process Flow Diagram of 2, 8-Diazo bicyclo Nonane



Table 2.23 Material Balance for 2, 8-Diazo bicyclo Nonane Stage I Input Quantity

(Kg/Day) Output Quantity

(Kg/Day) Remarks

2,3-Pyridine Dicarboxylicacid


Acetic anhydride 188.9 Acetic acid 176.3 To wastewater Toluene 500 Methanol Recovered 720 Recovery & reuse Benzylamine 198.1 Methanol Loss 1.5 Fugitive Loss Methanol 750 Methanol to Residue 28.5 Solvent in Residue Toluene Recovered 485 Recovery & reuse Toluene Loss 1.3 Fugitive Loss Toluene to Residue 13.8 Solvent in Residue 2,3-Pyridine

Dicarboxylicacid 63.9 To Waste water

Acetic anhydride 39 Organic residue Benzylamine 40.9 Organic residue Total Input 1946.3 Total Output 1946.3 Stage II Input Quantity


(Kg/Day) Remarks

Stage I Product 376.1 Stage II Product 382 To Stage-III Ethyl acetate 2500 Ethyl acetate Recovered 2425 Recovery & reuse Pd/C 15 Ethyl acetate Loss 7.5 Fugitive Loss DM Water 3000 Ethyl acetate to water 20 To Wastewater Tartaricacid 120 Ethyl acetate to Residue 47.5 Solvent in Residue Methylene Dichloride 1200 MDC Recovered 1164 Recovery & reuse Sodium carbonate 65 MDC Loss 3.6 Fugitive Loss Hydrogen 9.5 MDC to Residue 32.4 Solvent in Residue Stage I Product 3.5 Organic residue Tartaricacid 120 To Wastewater Sodium carbonate 65 To Wastewater DM Water 3000 To Wastewater Hydrogen 0.1 Let Out into

atmosphere Pd/C 15 To Spent carbon Total Input 7285.6 Total Output 7285.6 Stage III Input Quantity


(Kg/Day) Remarks

Stage II Product 382 Stage III Product 327.9 To Stage-IV Tetrahydrofuron(THF) 3000 Sodium Borohydride 217.6 To wastewater Aluminium chloride 835.5 Aluminium chloride 809.6 Inorganic residue Sodium Borohydride 236.4 THF Recovered 2910 Recovery & reuse Water 3000 THF Loss 15 Fugitive Loss Hydrochloric acid 35 THF to Residue 75 Solvent in Residue



Toluene 2500 Toluene Recovered 2400 Recovery & reuse Sodium hydroxide 38.4 Toluene Loss 15 Fugitive Loss Toluene to Residue 85 Solvent in Residue Stage II Product 11.6 Organic residue Aluminium chloride 25.4 Inorganic residue Sodium Borohydride 7.2 To wastewater Sodium chloride 56 To wastewater Water 3071.7 To wastewater Total Input 10027.3 Total Output 10027.3 Stage IV Input Quantity


(Kg/Day) Remarks

Stage III Product 327.9 (S,S)-2,8-diazabicyclo[4.3.0] nonane

166.7 Final product

Methanol 2000.0 Toluene 121.7 Organic residue Pd/C 20 Methanol Recovered 1950 Recovery & reuse Hydrogen 3 Methanol Loss 15 Fugitive Loss Methanol to Residue 35 Solvent in Residue Stage III Product 42.1 Organic residue Pd/C 20 Ogranic residue Hydrogen 0.4 Let Out into

Atmosphere Total Input 2350.9 Total Output 2350.9



2.1.21 Process Description of 2, 3, 4, 5-Bis-O- (1- methylethylidene)-b-D-fructopyranose

Reaction Schemes

Stage I

Process Description: Stage -I: D-(-)-Fructose is reacted with acetone in presence of sulfuric acid in n-Hexane and

toluene to yield 2,3,4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose (Topiramate

Intermediate). The process flow diagram for 2, 3, 4, and 5-Bis-O-(1-methylethylidene)-beta-

D-fructopyranose (Topiramate Intermediate) is presented in Fig 2.21.Material balance is

presented in Table 2.24.

Fig 2.21 Process Flow Diagram of 2, 3, 4, 5-Bis-O- (1- methylethylidene)-b-D-fructopyranose



Table 2.24 Material Balance for 2, 3, 4, 5-Bis-O- (1- methylethylidene)-b-D-fructopyranose Input Quantity


(Kg/day) Remarks

D-(-)-Fructose 646 2,3,4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose (Topirama Intermediate)

833.3 Final Product

Sulfuric acid 150 Acetone Recovered 760 Recovery & reuse Sodium hydroxide 122.4 Acetone Loss 6.4 Fugitive Loss Acetone 416.3 Acetone to wastewater 6.6 To Wastewater n-Hexane 1000 Acetone to Residue 27 Solvent in Residue Toluene 3000 n-Hexane Recovered 950 Recovery & reuse Isopropanol (IPA) 150 n-Hexane Loss 8 Fugitive Loss Water 6000 n-Hexane to Residue 42 Solvent in Residue Acetone 800 Toluene Recovered 2850 Recovery & reuse Toluene Loss 24 Fugitive Loss Toluene to wastewater 12.9 To Wastewater Toluene to Residue 113.1 Solvent in Residue IPA Recovered 142.5 Recovery & reuse IPA Loss 1.2 Fugitive Loss IPA to wastewater 1.4 To Wastewater IPA to Residue 4.9 Solvent in Residue D-(-)-Fructose 69.1 To Wastewater Acetone 45 To Wastewater Sodium sulfate 217.3 To Wastewater Water 6170.5 To Wastewater Total Input 12284.8 Total Output 12284.8



2.1.22 Process Description of 2- Acetyl Ethoxy acetyl methoxy ether

Reaction Schemes

Process Description

Stage-I: Acetic anhydride reacted with 1, 3 Dioxolane in presence of Sodium acetate and

sulfuric acid to gives (2-Acetoxyethoxy) methyl acetate.Process flow diagram is presented in

Fig 2.22.Material balance is presented in Table 2.25.

Fig 2.22 Process Flow Diagram of 2- Acetyl Ethoxy acetyl methoxy ether

Table 2.25 Material Balance for 2- Acetyl Ethoxy acetyl methoxy ether Input Quantity


(Kg/day) Remarks

Acetic anhydride 896.5 (2-Acetoxyethoxy)methyl acetate

1133 Final Product

1,3-Dioxolane 651.1 Acetic anhydride 240.3 Organic Residue Sodium acetate 3.0 1,3-Dioxolane 174 Organic residue Sulfuric acid 2.0 Sodium acetate 3 To Wastewater Sodium Hydroxide 1.6 Sodium sulfate 2.9 To Wastewater Water 80 Water 80.7 To Wastewater Total Input 1634.3 Total Output 1634.4



2.1.23 Process Description of 1, 1-Carbonyl di imidazole

Reaction Schemes

Process Description

Stage-I: Imidazole Reacted with triphosgene in presence of Tributylamine in toluene to

gives 1, 1’-carbonyldiimidazole. Process flow diagram is presented in Fig 2.23.Material

Balance is presented in Table 2.26.

Fig 2.23 Process Flow Diagram of 1, 1-Carbonyl di imidazole

Table 2.26 Materila Balance of 1, 1-Carbonyl di imidazole



Remarks

1H Imidazole 2043.1 1,1-Carbonyl diimidazole

1666.7 Final Product

bis(trichloromethyl) carbonate

4452 Trichloromethanol 2782.5 By-Product

Tri butyl amine 3200 Toluene Recovered 8288 Recovery & reuse Toluene 8500 Toluene Loss 43 Fugitive Loss Toluene to Residue 170 Solvent in Residue 1H Imidazole 257.4 Organic Residue 386.2 Recovered & Reused bis(trichloromethyl)

carbonate 701.2 Organic Residue

701.2 Recovered & Reused Tri butyl amine 1280 Organic Residue 1920 Recovered & Reused Total Input 18195.1 Total Output 18195.1



2.1.24 Process Description of (2S, 3S, 5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1, 6-diohenyl Reaction Schemes

Stage I

Stage II

Stage III




Stage-I: Phenyl alanine and Benzyl chloride is reacted with acetonitrile and benzyl

magnesium chloride in presence of sodium amide and then treated with water in

tetrahydrofuran to yield Dibenzylamino diphenyl hexene (Stage-I compound).

Stage-II: Dibenzylamino diphenyl hexene is reacted with sodium borohydride in presence

of Methanol and then treated with Boc anhydride to yield Hydroxy butyloxy

carbonylamino diphenyl hexane (Stage II Compound).

Stage-III: Hydroxy butyloxy carbonylamino diphenyl hexane is deprotected with

Palladium carbon in presence of Methanol to yield Aminohydroxy butyloxy

diphenylhexane. The process flow diagram for Aminohydroxy butyloxy diphenyl hexane is

presented in Fig 2.24.and material balance is presented in Table 2.27.



Fig 2.24 Process Flow Diagram of (2S, 3S, 5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl

Amino 1, 6-diohenyl



Table 2.27 Material Balance for (2S, 3S, 5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1, 6-diohenyl



(Kg/day) Remarks

Phenyl alanine 62.4 Stage I Product 163.8 To Stage-II Benzyl chloride 95.7 Magnesium Hydroxide 20.6 To Waste water Benzyl magnesium chloride

56.9 Sodium Chloride 62.4 To Wastewater

Sodium amide 14.7 Ammonium Hydroxide 12.4 To waste water Caustic Lye (40%) 71.1 THF Recovered 945 Recovery & reuse Acetonitrile 15.9 THF Loss 10 Fugitive Loss Tetrahydrofuran (THF) 1000 THF to Wastewater 13 To wastewater Activated carbon 10 THF to Residue 32 Solvent in Residue Water 1113.6 Phenyl alanine 3.7 Organic residue Benzyl chloride 5.7 Organic residue Benzyl magnesium

chloride 3.4 Organic residue

Acetonitrile 1 To wastewater Activated carbon 10 To spent carbon Sodium amide 0.9 To wastewater Water 1156 To wastewater Total Input 2440.3 Total Output 2440.3 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 163.8 Stage II Product 163.9 To Stage-III Sodium borohydride 13.5 Tert-Butyl alcohol 21.5 To Waste water Boc anhydride 77.6 Sodium trymethoxy

borohydride 37.2 Organic residue

Methanol 34.2 Carbon Dioxide 12.8 Let out into atmosphere

Water 650 Hydrogen 0.6 Let into atmosphere through water column

Activated carbon 8 Methanol Recovered 479.5 Recovery & reuse Methanol 500 Methanol Loss 2 Fugitive Loss Methanol to Wastewater 6.5 To wastewater Methanol to Residue 12 Solvent in Residue Stage I Product 30.15 Organic residue Boc anhydride 14.3 Organic residue Activated carbon 8 To spent carbon Methanol 6.3 To Waste water Sodium borohydride 2.5 To Waste water Water 650 To Waste water Total Input 1447.2 Total Output 1447.2



Stage III Input Quantity


(Kg/day) Remarks

Stage II Product 163.9 Aminohydroxy butyloxy diphenylhexane

100 Final Product

Hydrogen 1.2 Toluene 47.9 To wastewater Palladium carbon 20 Methanol Recovered 1455 Recovery & reuse Methanol 1500 Methanol Loss 6 Fugitive Loss Activated carbon 10 Methanol to Wastewater 9 To wastewater Water 1500 Methanol to Residue 30 Solvent in Residue Stage II Product 17 Organic residue Activated carbon 10 To spent carbon Hydrogen 0.1 Let into atmosphere

through water column

Palladium carbon 20 To spent catalyst Water 1500 To Waste water Total Input 3195.1 Total Output 3195.1



2.1.25 Process Description of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid Reaction Schemes

Stage I

Stage II


Stage-I: Tetra hydrobenzene is reacted with monochlorobenzene and Acetyl chloride in

presence of Con.HCl, AlCl3 and Toluene to give Trans-1-[4-(4-chlorophenyl)-cyclohexyl]-

ethanone (Stage-I compound).

Stage-II: Trans-1-[4-(4-chlorophenyl)-cyclohexyl]-ethanone is reacted with Sodium

hypochlorite and water in presence of NaOH, Sodium bisulphite and Ethanol to give Trans-

4-(4-chlorophenyl) cyclohexane carboxylic acid (Stage-II compound). The process flow

diagram for Trans-4-(4-chlorophenyl) cyclohexane carboxylic acid is presented in Fig 2.25.

And material balance is presented in Table 2.28.



Fig 2.25 Process Flow Diagram of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid



Table 2.28 Material Balance for Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid Stage I Input Quantity


(Kg/day) Remarks

Tetrahydrobenzene 41 Stage I Product 105.3 To Stage II Monochlorobenzene 56.2 Toluene Recovered 386 Recoverd & Reused Aluminium Trichloride 15 Toluene Loss 2 Fugitive Loss Acetyl chloride 39.2 Toluene to Wastewater 4 To Wastewater Crushed ice 500 Toluene to Residue 8 Solvent in Residue Toluene 400 Ethanol Recovered 241.3 Recoverd & Reused 10 % NaCl solution 20 Ethanol Loss 1.3 Fugitive Loss Sodium Hydroxide 17.8 Ethanol to Wastewater 2.5 To Wastewater Ethanol 250 Ethanol to Residue 5 Solvent in Residue Monochlorobenzene (MCB)

500 MCB Recovered 482.5 Recoverd & Reused

MCB Loss 2.5 Fugitive Loss MCB to Wastewater 5 To Wastewater MCB to Residue 10 Solvent in Residue Tetrahydrobenzene 4.5 Organic residue Monochlorobenzene 6.1 Organic residue Acetyl chloride 4.3 Organic residue Aluminium Trichloride 15 To Wastewater Sodium Chloride 28 To Wastewater Water 526 To Wastewater Total Input 1839.2 Total Output 1839.2 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 105.3 Trans-4-(4-chlorophenyl)cyclo hexane carboxylic acid

100 Final Product

Ethanol 1000 Carbon Monoxide 11.7 Let into Atmosphere Sodium Hydroxide 12 Ethanol Recovered 965 Recoverd & Reused Sodium hypo chlorite 99.5 Ethanol Loss 5 Fugitive Loss Sodium Sulphite 15 Ethanol to Wastewater 10 To Wastewater Hexane 200 Ethanol to Residue 20 Solvent in Residue Con. Hydro chloric acid 11 Toluene Recovered 97 Recoverd & Reused Toluene 100 Toluene Loss 0.4 Fugitive Loss Water 2024 Toluene to Wastewater 0.5 To Wastewater Toluene to Residue 2.1 Solvent in Residue Hexane Recovered 194 Recoverd & Reused Hexane Loss 0.8 Fugitive Loss Hexane to Wastewater 1 To Wastewater Hexane to Residue 4.2 Solvent in Residue Stage I Product 6.1 Organic Residue Sodium chloride 113.8 To Wastewater



Sodium hypo chlorite 5.8 To Wastewater Sodium sulphite 15 To Wastewater Water 2014.3 To waste water Total Input 3566.7 Total Output 3566.7

2.1.26 Process Description of Guanine Reaction Schemes


Stage-I: 2,5,6-Triamino-3H-pyrimidin-4-one reacted with sulphuric acid & formic acid in

presence of water and sodium formate to give guanine.Process flow diagram is presented in

Fig 2.26. Material balance is presented in Table 2.29.

Fig 2.26 Process Flow Diagram of Guanine

Table 2.29 Material Balance for Guanine Input Quantity


(Kg/day) Remarks

2,5,6-Triamino-3H-pyrimidin-4-one

2299 Guanine 1666.7 Final Product

Sulfuric Acid 1598 Water 1384.3 To wastewater Formic Acid 750 2,5,6-Triamino-3H-

pyrimidin-4-one 742.5 Organic Residue

Sodium Formate 1520 Formic Acid 242 To Wastewater Water 400 Sodium Formate

456 Organic residue

Sodium Hydroxide 1304 1064 Recovered & reused Sodium sulfate

2199.4 Inorganic residue

115.8 To Wastewater Total Input 7870.9 Total Output 7870.9



2.1.27 Process Description of Poly allyl amine HCl Reaction Schemes


Stage-I: Polyallyl amine is reacted with hydrochloric acid in presence of water and 2, 2’-

Azobis-(2-methylpropanamide) to yield Polyallylamine Hydrochloride.Process flow


Fig 2.27 Process Flow Diagram of Poly allyl amine HCl

Table 2.30 Material Balance for Poly allyl amine HCl Input Quantity


(Kg/day) Remarks

Polyallylamine 355 Polyallylamine HCl 500 Final Product Hydrochloric acid 227 Polyallylamine 50.4 Organic Residue Water 3200 2,2’-Azobis-(2-methyl

propanamide) 4.1 To Wastewater

2,2’-Azobis-(2-methyl propanamide)

4 Sodium chloride 51.8 To Wastewater

Sodium Hydroxide 35 Water 3215.9 To Wastewater Total Input 3822.2 Total Output 3822.2



2.1.28 Process Description of Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido)Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate Reaction Schemes

Stage I

Stage II

Stage III




Stage-I:Tert-Butyl-2 ((4R,6S)-6- (acetyloxy) methyl-2,2-dimethyl-1,3-dioxan-4-yl)acetate

reacts with water to form Tert-Butyl-2((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl1,3-dioxan-4-

yl)acetate. (Stage-I compound).

Stage-II: Tert-Butyl-2((4R, 6S)-6-(hydroxymethyl)-2, 2-dimethyl-1,3-dioxan-4-yl)acetate

reacts with Sodium hypochlorite to form Tert-Butyl-2((4R,6S)-6-formyl-2,2-dimethyl-1,3-

dioxan-4-yl)acetate. (Stage II compound).

Stage-III: Tert-Butyl-2((4R,6S)-6-formyl-2,2-dimethyl-1,3-dioxan-4-yl)acetate is condense

with[[4-(4-Fluorophenyl)-6-(1-methylethyl)2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]

methyl] triphenylphoshonium bromide to form tert-butyl-2-((4R,6S)-6-((E)-2-(4-(4-

fluorophenyl)-6-isopropyl-2-(n-methylmethanesulfonamido)pyrimidin-5-yl)vinyl)-2,2-di

methyl - 1,3-dioxane-4-yl)acetate. (Stage-III compound).Process flow diagram is presented

in Fig 2.28.Material balance is presented in Table 2.31.



Fig 2.28 Process Flow Diagram of Tert-butyl 2-((4R, 6S)-6-((E)-2-(4-(4-flurophenyl)-6-

isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate



Table 2.31 Material Balance for Tert-butyl 2-((4R, 6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-

dioxane-4-yl-) acetate Stage I Input Quantity


(Kg/day) Remarks

Tert-Butyl-2((4R,6S)-6-(acetyloxy)methyl-2,2-dimethyl-1,3-dioxan-4-yl) acetate


Methanol 350 Acetic acid 28.6 To wastewater Potassium carbonate 30 Methanol Recovered 336 Recovery & reuse Water 8.7 Methanol Loss 0.7 Fugitive Loss Methylene dichloride (MDC)

750 Methanol to Wastewater 3.5 To wastewater

Water 1500 Methanol to Residue 9.8 Solvent in Residue MDC Recovered 720 Recovery & reuse MDC Loss 1.5 Fugitive Loss MDC to Wastewater 7.5 To wastewater MDC to Residue 21 Solvent in Residue Tert-Butyl-2((4R,6S)-6-

(acetyloxy)methyl-2,2-dimethyl-1,3-dioxan-4-yl)acetate

1.5 Organic residue

Potassium carbonate 30 To wastewater Water 1500 To wastewater Total Input 2784.2 Total Output 2784.2 Stage II Input Quantity


(Kg/day) Remarks

Stage I Product 124.1 Stage II Product 119.3 To Stage-III Sodium hypochlorite 35.4 MDC Recovered 960 Recovery & reuse Sodium bicarbonate 30 MDC Loss 2 Fugitive Loss Water 1800 MDC to Wastewater 10 To wastewater Potassium bromide 5 MDC to Residue 28 Solvent in Residue Methylene dichloride (MDC)

1000 Stage I Product 3.72 Organic residue

Sodium thiosulphate 30 Sodium hypochlorite 1.1 To wastewater Sodium chloride 25 Sodium bicarbonate 30 To wastewater Potassium bromide 5 Inorganic residue Sodium thiosulphate 30 To wastewater Sodium chloride 60 To wastewater Water 1800 To wastewater Total Input 3049.4 Total Output 3049.4

Stage III





Remarks

Stage II Product 119.3 Tert-Butyl-2-((4R,6S)-6-€-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido) pyrimidin-5-yl) vinyl)-2,2-dimethyl-1,3-dioxane-4-yl) acetate

166.7 Final Product

[[4-(4-Fluorophenyl)-6-(1-methylethyl)2-[methyl (methylsulfonyl) amino]-5-pyrimidinyl]methyl] triphenyl phoshonium bromide

313.4 Triphenyl Phosphene oxide

80.3 To wastewater

Dimethyl sulfoxide (DMSO)

850 Bromine 23.4 To Scrubber

Potassium carbonate 50 Methanol Recovered 768 Recovery & reuse Toluene 1800 Methanol Loss 1.6 Fugitive Loss Water 1500 Methanol to Wastewater 8 To wastewater Methanol 800 Methanol to Residue 22.4 Solvent in Residue DIP 700 Toluene Recovered 1728 Recovery & reuse Hexane 600 Toluene Loss 3.6 Fugitive Loss Toluene to Wastewater 18 To wastewater Toluene to Residue 50.4 Solvent in Residue DIP Recovered 672 Recovery & reuse DIP Loss 1.4 Fugitive Loss DIP to Wastewater 7 To wastewater DIP to Residue 19.6 Solvent in Residue Hexane Recovered 576 Recovery & reuse Hexane Loss 1.2 Fugitive Loss Hexane to Wastewater 6 To wastewater Hexane to Residue 16.8 Solvent in Residue DMSO Recovered 816 Recovery & reuse DMSO Loss 1.7 Fugitive Loss DMSO to Wastewater 8.5 To wastewater DMSO to Residue 23.8 Solvent in Residue Stage II Product 44.7 Organic residue Organic Impurities 117.5 Organic residue Potassium carbonate 50 To wastewater Water 1500 To wastewater Total Input 6732.7 Total Output 6732.7



2.1.29 Process Description of 5-Cyano phthalide Reaction Schemes

Stage I

Stage II

Stage III

Process Description: Stage-I: 5-Carboxy phthalide reacts with thionyl chloride and ammonia Gas to get 5-

Phthalide carboxamide.

Stage-II: 5-Phthalide carboxamide reacts with Thynoyal chloride to get 5-cyano phthalide

(crude).



Stage-III: 5-cyano phthalide (crude) undergoes purification with Dimethyl formamaide and

Methanol to get 5-cyano phthalide.Process flow diagram is presented in Fig 2.29.And

material balance is presented in Table 2.32.

Fig 2.29 Process Flow Diagram of 5-Cyano phthalide



Table 2.32 Material Balance for 5-Cyano phthalide Stage I Input Quantity


(Kg/Day) Remarks

5-Carboxy Phthalide 1636.4 Stage I Product 1514.6 To Stage-II Thionyl Chloride 1017.4 Sulfur Dioxide 547.3 To Scrubber Toluene 2800 Hydrogen chloride 624.3 To Scrubber Di Methyl Formamide 20 Toluene Recovered 2688 Recovery & reuse Ammonia Gas 156.2 Toluene Loss 5.6 Fugitive Loss Water 2300 Toluene to Wastewater 28 To wastewater Toluene to Residue 78.4 Solvent in Residue 5-Carboxy Phthalide 112.9 Organic residue Di Methyl Formamide 20.0 To wastewater Ammonia Gas 10.8 To Scrubber Water 2300 To wastewater Total Input 7930 Total Output 7930 Stage II Input Quantity


(Kg/Day) Remarks

Stage I Product 1514.6 Stage II Product 1091.2 To Stage-III Thionyl chloride 816.7 Sulfur Dioxide 439.2 To Scrubber Ethylene Dichloride (EDC) 3500 Hydrogen Chloride 501.0 To Scrubber Di Methyl Formamide 25 Methanol Recovered 960 Recovery & reuse Methanol 1000 Methanol Loss 2 Fugitive Loss Methanol to Wastewater 0.0 To wastewater Methanol to Residue 38 Solvent in Residue EDC Recovered 3360 Recovery & reuse EDC Loss 7 Fugitive Loss EDC to Wastewater 0.0 To wastewater EDC to Residue 133 Solvent in Residue Stage I Product 299.89 Organic residue Di Methyl Formamide 25 Organic residue Total Input 6856.2 Total Output 6856.2 Stage III Input Quantity


(Kg/Day) Remarks

Stage II Product 1091.2 5 Cyano Phthalide 666.7 Final Product Dimethylformamide 2500.0 Methanol Recovered 192 Recovery & reuse Hyflow 8 Methanol Loss 0.4 Fugitive Loss Methanol 200 Methanol to Wastewater 0.0 To wastewater Methanol to Residue 7.6 Solvent in Residue DMF Recovered 2400 Recovery & reuse DMF Loss 5 Fugitive Loss DMF to Wastewater 0.0 To wastewater DMF to Residue 95 Solvent in Residue Stage II Product 424.46 Organic residue Hyflow 8 Inorganic residue Total Input 3799.2 Total Output 3799.2



2.1.30 Process Description of 1, 1-Cyclohexanediacetic acid Reaction Schemes

Stage I

Process Description: Stage-I:

Cyclohexanone reacted with methyl cyanoacetate and ammonia gas in presence of Toluene

to gives 1, 1-cyclohexyl dicyano amide and this under goes to hydrolysis with water to

gives 1, 1-Cyclohexanediacetic acid.Process flow diagram is presented in Fig 2.30.Material

balance can be presented in Table 2.33.

Fig 2.30 Process Flow Diagram of 1, 1-Cyclohexanediacetic acid



Table 2.33 Material Balance for 1, 1-Cyclohexanediacetic acid Input Quantity


(Kg/Day) Remarks

Cyclohexanone 989.1 1,1-cyclohexane di aceticacid

1666.7 Product

2-methyl cyano acetate 1995.9 Ammonia gas 566.7 To Scrubber Ammonia gas 325.6 Carbon dioxide 733.3 Let into Atmosphere Toluene 3000 Methanol

266.7 To wastewater

Water 5588.7 266.7 Recovered & resued Sulfuric Acid 50 IPA Recovered 4850 Recovery & reuse Isopropanol (IPA) 5000 IPA Loss 12.5 Fugitive Loss Sodium Hydroxide 40.8 IPA to Wastewater 35.5 To wastewater IPA to Residue 102 Solvent in Residue Toluene Recovered 2910 Recovery & reuse Toluene Loss 7.5 Fugitive Loss Toluene to

Wastewater 12.3 To wastewater

Toluene to Residue 70.2 Solvent in Residue Cyclohexanone 171.4 Organic residue 2-methyl cyano

acetate 345.9 Organic residue

Ammonia gas 42.3 To Scrubber Sodium sulfate 72.7 To Waste water Water 4857 To Waste water

Total Input 16990.1 Total Output 16990.3



2.1.31 Process Description of Carbamyl Methyl-5-Methyl hexanoic Acid Reaction Schemes


Stage-I: Isovaleraldehyde reacted with Cyanoacetamide, water and urea in presence of

hydrochloric acid to gives 3-(Carbamoylmethyl)-5-methylhexanoic acid.Process flow


Fig 2.31 Process Flow Diagram of Carbamyl Methyl-5-Methyl hexanoic Acid



Table 2.34 Material Balance for Carbamyl Methyl-5-Methyl hexanoic Acid Input Quantity


(Kg/Day) Remarks

Isovalaraldehyde 285.5 3-Carbomylmethyl-5-methylhexanoic acid

500 Final Product

2-Cyanoacetamide 557.4 Ammonia gas 227.3 To Scrubber Water 477.3 Carbon dioxide 352.5 Let into

Atmosphere Urea 199 Toluene Recovered 2425 Recovery & reuse Hydrochloric acid (33%) 100 Toluene Loss 2.5 Fugitive Loss Toluene 2500 Toluene to Wastewater 10.3 To wastewater Ethylacetate 1200 Toluene to Residue 62.3 Solvent in Residue Piperidine 12 Ethylacetate Recovered 1164 Recovery & reuse Sodium Hydroxide 36.2 Ethylacetate Loss 3 Fugitive Loss Ethylacetate to water 12 To wastewater Ethylacetate to Residue 21 Solvent in Residue

Isovalaraldehyde 55.5 Organic Residue 2-Cyanoacetamide 108.36 Organic Residue Urea 38.7 Organic Residue Sodium Chloride 53 To wastewater Piperidine 12 Inorganic residue Water 320.3 To wastewater




2.1.32 Process Description of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine Reaction Schemes

Stage I

Stage II


Stage-I: Methyl-2,3-O-isopropylidene-5-deoxy-D-ribofuranoside reacts with Acetic

anhydride in presence of DM water, sulphuric acid, sodium carbonate, triethyl amine,

methylene chloride, hydrochloric acid and sodium sulphate to form 1,2,3-Tri-o-acetyl-5-

deoxy-beta-D-ribofuranose.

Stage-II: 1,2,3-Tri-o-acetyl-5-deoxy-beta-D-ribofuranose condensed with 5-Fluorocytidine in

presence of Toluene, hexamethyldisilazane, trimethyl chlorosilane, methylene chloride,

stannic chloride, sodium bicarbonate, water, sodium bicarbonate and isopropyl alcohol to

form 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine.Process flow diagram is presented in Fig

2.32.Material balance is presented in Table 2.35.



Stage I

Stage II

Fig 2.32 Process Flow Diagram of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine



Table 2.35 Material Balance for 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine Stage I Input Quantity


(Kg/Day) Remarks

Methyl-2,3-O-isopropylidene-5-deoxy-D-ribofuranoside


Acetic anhydride 114 Methanol 16.1 To wastewater DM Water 650.2 propane-2,2-diol 38.2 To wastewater Tri ethylamine (TEA) 200 Acetic acid 30.2 To wastewater Methylene Dichloride (MDC)

600 TEA Recovered 194 Recovery & reuse

Di isopropyl ether (DiPE) 400 TEA Loss 0.5 Fugitive Loss Sulfuric acid 10 TEA to Wastewater 2 To wastewater Sodium carbonate 5 TEA to Residue 3.5 Solvent in Residue Hyflow 5 MDC Recovered 582 Recovery & reuse Activated carbon 10 MDC Loss 2.1 Fugitive Loss Sodium Hydroxide 8.2 MDC to Wastewater 1.9 To wastewater MDC to Residue 14 Solvent in Residue DiPE Recovered 388 Recovery & reuse DiPE Loss 1.4 Fugitive Loss DiPE to Wastewater 4.0 To wastewater DiPE to Residue 6.6 Solvent in Residue Stage III Product 10.5 Organic residue Acetic anhydride 11.4 Organic residue Sodium sulfate 14.5 To wastewater Sodium carbonate 5 To wastewater Hyflow 5 inorganic residue Activated carbon 10 To spent carbon Water 635.8 To wastewater 2107.4 Total Output 2107.5 Stage II Input Quantity


(Kg/Day) Remarks

Stage I Product 130.8 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine

133.3 Final Product

5-Fluorocytosine 64.9 Acetic acid 24.3 To wastewater Toluene 500 Toluene Recovered 475 Recovery & reuse Dichloro methane (DCM) 850 Toluene Loss 10 Fugitive Loss Isopropyl alcohol (IPA) 400 Toluene to Wastewater 5 To wastewater Hexa methyl disilazane 25 Toluene to Residue 10 Solvent in Residue Tri methyl chlorosilane 12 DCM Recovered 824.5 Recovery & reuse Stannic chloride 35 DCM Loss 2.1 Fugitive Loss Sodium bi carbonate 25 DCM to Wastewater 8.5 To wastewater Sodium carbonate 8 DCM to Residue 14.9 Solvent in Residue Water 600 IPA Recovered 380 Recovery & reuse



IPA Loss 8 Fugitive Loss IPA to Wastewater 4 To wastewater IPA to Residue 8 Solvent in Residue

Stage IV Product 25.4 Organic Residue 5-Fluorocytosine 12.6 Organic Residue Hexa methyl disilazane 25 Organic Residue Tri methyl chlorosilane 12 Organic Residue Stannic chloride 35 To wastewater Sodium bicarbonate 25 To wastewater

Sodium sulphate 8 Inorganic residue Water 600 To wastewater Total Input 2650.7 Total Output 2650.7



2.1.33 Process Description of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine Reaction Schemes

Stage I

Stage II


Stage-I: (2-Methyl-5-nitrophenyl) guanidine react with (E)-3-(dimethylamino)-1-(pyridin-3-

yl)prop-2-en-1-one in presence of sodium hydroxide in isopropyl alcohol to give 1,3-

benzenediamine, 4-methyl-N3-[4-(3-pyridinyl)]-2-pyrimidinyl. (Stage -II compound).

Stage-II: 1, 3-benzenediamine, 4-methyl-N3-[4-(3-pyridinyl)]-2-pyrimidinyl react with raney

Ni in presence of methanol to give N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine

amine. Process flow diagram is represented in Fig 2.33.Material balance is presented in

Table 2.36.



Fig 2.33 Process Flow Diagram of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-

pyrimidine amine



Table 2.36 Material Balance for N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine



(Kg/Day) Remarks

(2-Methyl-5-nitrophenyl)guanidine.


(E)-3-(dimethylamino)-1-(pyridin-3-yl)prop-2-en-1-one

336.1 Dimethyl amine 83.3 Organic residue

Sodium hydroxide 80 n-butanol Recovered 2425 Recovery & reuse n-butanol 2500 n-butanol Loss 6.3 Fugitive Loss Isopropanol (IPA) 2000 n-butanol to water 20.3 To wastewater methanol 2000 n-butanol to Residue 48.5 Solvent in Residue water 2800 IPA Recovered 1940 Recovery & reuse Hydrochloric acid 73 IPA Loss 7 Fugitive Loss IPA to Wastewater 14.2 To wastewater IPA to Residue 38.8 Solvent in Residue Methanol Recovered 1940 Recovery & reuse Methanol Loss 7 Fugitive Loss Methanol to water 20 To wastewater Methanol to Residue 33 Solvent in Residue Organic Impurities 21.2 Organic residue Sodium chloride 116.9 To Waste water Water 2869.3 To wastewater 10159.2 Total Output 10159.2 Stage II Input Quantity


(Kg/Day) Remarks

Stage I Product 568.5 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine

333.3 Final Product

Hydrogen gas 11.1 Methanol Recovered 2425 Recovery & reuse Methanol 2500 Methanol Loss 6.3 Fugitive Loss Rany nickel 50 Methanol to water 25 To wastewater Water 600 Methanol to Residue 43.8 Solvent in Residue Stage I Product 199.1 Organic residue

Hydrogen gas 3.9 Let Into atmosphere through water column

Rany nickel 50 Residue Water 643.3 To wastewater Total Input 3729.6 Total Output 3729.6



2.1.34 Process Description of 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl Reaction Schemes

Stage I


Stage-I: 4-Cyanobenzyl bromide reacts with N-methyl piperazine in presence of Triethyl

amine and Toluene, Further this is reacts with HCl to give Benzoic acid, 4-[(4-methyl-1-

piperazinyl) methyl] dihydrochloride.Process flow diagram can be presented in Fig

2.34.Material balance is presented in Table 2.37.

Fig 2.34 Process Flow Diagram of 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl



Table 2.37 Material Balance for 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl Input Quantity


(Kg/Day) Remarks

4-Cyanobenzyl bromide

297.5 Benzoic acid, 4-[(4-methyl-1-piperazinyl) methyl] dihydrochloride

333.3 Final Product

N-Methyl piperazine 151.9 Hydrogen Bromide 87.8 To scrubber Triethyl amine (TEA) 150 Ammonium gas 18.5 To scrubber Toluene 1800 TEA Recovered 145.5 Recovery & reuse Con.HCl 31.6 TEA Loss 0.4 Fugitive Loss DM Water 2100 TEA to Wastewater 1.5 To wastewater Sodium Hydroxide 34.6 TEA to Residue 2.6 Solvent in Residue Water 54.6 Toluene Recovered 1746.0 Recovery & reuse Hydrochloric acid 110.8 Toluene Loss 4.5 Fugitive Loss Toluene to Wastewater 18 To wastewater Toluene to Residue 31.5 Solvent in Residue 4-Cyanobenzyl bromide 84.78 Organic residue

N-Methyl piperazine 43.29 Organic residue Sodium chloride 50.5 To wastewater DM Water 2131.6 To wastewater




2.1.35 Process Description of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide Reaction Schemes

Stage I

Stage II

Stage III


Stage-I: 2-Methylacrylic acid reacts with Thionyl chloride in presence of

Dimethylformamide to form 2-Methylacrylolyl chloride (Stage-I compound).

Stage-II: 2-Methylacrylolyl chloride is condense with 4-Amino-2-

(trifluoromethyl)benzonitrile in presence of N,N-dimethyl acetamide, Water, Toluene and

4-Dimethylamino pyridine to form N-[4-Cyano-3-(trifluoromethyl)phenyl]meth-acrylamide.

(Stage II compound).

Stage-III: N-[4-Cyano-3-(trifluoromethyl)phenyl]meth-acrylamide reacts with m-Chloro

perbenzoic acid in presence of Chloroform, water, Toluene, Dimethylformamide,Sodium



Bicarbonate and Sodium sulphate to formcyano-3-(trifluoromethyl)phenyl] propanamide.

Process flow diagram is presented in Fig 2.35.Material balance is presented in Table 2.38.

Fig 2.35 Process Flow Diagram of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl)

phenyl] propanamide



Table 2.38 Material Balance for 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide



(Kg/Day) Remarks

2-Methylacrylic acid 92.9 Stage I Product 101.6 To Stage-II Thionyl chloride 115.7 Sulfur Dioxide 62.2 To Scrubber Dimethylformamide (DMF)

20 Hydrogen Chloride 35.5 To Scrubber

DMF Recovered 19.2 Recovery & reuse DMF Loss 0.2 Fugitive Loss DMF to Residue 0.6 Solvent in Residue 2-Methylacrylic acid 9.3 Organic residue Total Input 228.6 Total Output 228.6 Stage II Input Quantity


(Kg/Day) Remarks

Stage I Product 101.6 Stage II Product 222.3 To Stage-III 4-Amino-2-(trifluoromethyl) benzonitrile

180.9 Toluene Recovered 970 Recovery & reuse

N,N-Dimethyl acetamide (DMA)

1500 Toluene Loss 2.5 Fugitive Loss

Toluene 1000 Toluene to water 10 To wastewater 4-Dimethylamino pyridine

5 Toluene to Residue 17.5 Solvent in Residue

Water 5000 DMA Recovered 1455 Recovery & reuse Sodium Hydroxide 35.0 DMA Loss 5.3 Fugitive Loss DMA to water 15 To wastewater DMA to Residue 24.8 Solvent in Residue Stage I Product 10.2 Organic residue 4-Amino-2-

(trifluoromethyl) benzonitrile



5 Organic residue

Sodium chloride 51.1 To wastewater Water 5015.8 To wastewater 7822.5 Total Output 7822.5



Stage III Input Quantity


(Kg/Day) Remarks

Stage II Product 222.3 2,3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide

166.7 Final Product

m-chloroperbenzoic acid

151 m-chloro benzoic acid 96.6 To wastewater

Chloroform 800 Chloroform Recovered 776 Recovery & reuse Toluene 600 Chloroform Loss 2 Fugitive Loss Dimethylformamide (DMF)

300 Chloroform to water 8 To wastewater

Sodium bicarbonate 150 Chloroform to Residue 14 Solvent in Residue Sodium sulphate 85 Toluene Recovered 570 Recovery & reuse Water 2500 Toluene Loss 12 Fugitive Loss Toluene to water 6 To wastewater Toluene to Residue 12 Solvent in Residue DMF Recovered 285 Recovery & reuse DMF Loss 7.5 Fugitive Loss DMF to Wastewater 3 To wastewater DMF to Residue 4.5 Solvent in Residue

Stage II Product 65.5 Organic Residue m-chloroperbenzoic acid 44.5 To wastewater Sodium bicarbonate 150 To wastewater

Sodium sulphate 85 To wastewater Water 2500 To wastewater Total Input 4808.2 Total Output 4808.2



2.2 Utilities

The proposed expansion requires additional steam for both process and effluent treatment

system. It is proposed to establish coal fired boilers of capacity of 2 x 10 TPH in addition to

existing 2 TPH coal fired boiler. The DG sets required for emergency power during load

shut down is estimated at 2250 KVA and accordingly 2 x 1000 Kva DG sets are proposed for

expansion in addition to existing 1 x 250 Kva. The list of utilities is presented in Table 2.39.

Table 2.39 List of Utilities S.No Utility Permitted Proposed After Expansion

1 Coal Fired Boilers (TPH) 1 x 2 2 x 10

2 x 10 1 x 2

2 Thermic Fluid Heater (K.Cal) 1 Lac --- 1 Lac 3 DG Sets (kVA)* 1 x 250 2 x 1000 2 x 1000

1 x 250 *DG sets will be used during load shut down by TSPDCL.

2.3 Water Requirement (Terms of Reference No. 3(vii))

Water is required for process, scrubbers, washing, cooling tower makeup, steam generation

and domestic purposes. The total water requirement after expansion increased from 13.76

KLD to 468.3 KLD out of which 298.27 KLD fresh water and 170 KLD of recycled water. The

required water shall be drawn from ground water in addition to reuse of treated

wastewater. The water balance for daily consumption after expansion is presented in Table

2.40.

Table 2.40 Total Water Balance – After Expansion

Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent

Process 91.27 102.56* Washings 10 10 Scrubber 10 10 Boiler 95 85 10 Cooling Tower 60 160 194 26 RO/DM Rejects 24 24 Domestic 10 1.5 8.5 Water for gardening 8 8 Gross Total 298.27 170 288.5 191.03 Total 468.3 479.56

* Process Effluents contains unreacted raw materials, soluble solvents, by-products etc.



2.4 Pollution Control Facilities:

Liquid Effluents, air emissions and solid wastes generated are the major pollutants from the

process operations of bulk drug manufacturing. The pollution control measures proposed to

treat/mitigate the emissions and effluents are described as follows.

2.4.1 Water Pollution:

The effluent generated from the proposed expansion of M/s. Cirex Pharmaceuticals Limited

is mainly from process, washings, scrubbers, cooling towers & boiler blow downs, RO/DM

rejects from pre-treatment of water and domestic effluent. It is proposed to treat all HTDS

effluent in stripper followed by MEE and ATFD. All LTDS effluent along with condensate

from MEE & ATFD shall be treated in Biological treatment followed by RO system. RO

Rejects sent to MEE and permeate is used for cooling towers as make up and scrubbers.

Total Effluent generated and mode of treatment before and after expansion is presented in

Table 2.41. Quantity and quality of effluents generated from process product wise is

presented in Table 2.42 and stage wsie is presented in Table 2.43.

Table 2.41 Total Effluent Generated and Mode of Treatment Description Quantity (KLD) Mode of Treatment

Permitted After Expansion

HTDS Effluents Process 4.52 102.56 Sent to Stripper followed by MEE and ATFD.

Stripper Condensate sent to Cement Plants for Co-Incineration. MEE and ATFD Condensate sent to Biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers make-up and scrubbers.

Washings 1 10

Scrubber Effluent 10 Sent to MEE followed by AFTD, Biological treatment plant and RO. RO/DM Plant

Rejects 24

Total I 5.52 146.56 LTDS Effluents

Boiler Blow downs 1 10 Sent to Biological Treatment System followed by RO. RO permeate reused for cooling tower makeup and scrubbers. RO rejects sent to MEE.

Cooling Tower Blow downs

0.5 26

Domestic 1 8.5 Total II 2.5 44.5 Grand Total (I+II) 8.02 191.06



Table 2.42 Process Effluents - Quality and Quantity - Product Wise S.No Name of Product Quantity (Kg/day) Concentration

(mg/l) Water Input

TDS COD Total Effluent

TDS COD

1 Amlodipine Besylate 3528.4 230 220.7 3894.1 59064 56675 2 Bupropion 3200 360 70.6 3601.1 99969 19617 3 Clopidogrel 3300 134.2 205.0 3707.5 36210 55288 4 Desvelofloxin 3000 9.6 148.5 3155.6 3040 47068 5 Divolproex Sodium 0 1.2 0 34.4 34121 0 6 Dulaxetine HCl 1100 46.8 52.4 1191 39258 43967 7 Esomeprazole MgTrihydrate 4833.5 241.3 146.7 5235.5 46081 28012 8 Glimepiride 1200 32.0 33 1260.1 25395 26167 9 Mesalamine 3600 312.3 65.7 4007.8 77931 16383 10 Metaprolol 3300 104.5 12.7 3441.3 30355 3679 11 Pantoprazole Na 3445 453.3 43.6 5055.7 89666 8634 12 Pragabalin 3578.7 307.6 228.9 4214.5 72980 54312 13 Rosuvastatin 1112.5 23.2 44.6 1158.9 19985 38497 14 Sertraline HCl 3500 111.3 338.7 3872 28754 87488 15 Tramadal 6053.6 454.5 200.7 6750.6 67329 29735 16 Valaciclovir 5555.1 253.1 491.3 6650.5 38064 73878 17 4-[4-Chloro-1-oxobutyl]-2, 2-

dimethyl phenyl acetic acid methyl ester

6500 528.0 55.2 7515.2 70264 7343

18 N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl- L-lysine

2700 122.9 122.7 3065.1 40094 40030

19 2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl) ethenyl] phenyl]-3-hydroxy propyl] phenyl]-2-propanol.

4304.8 466.3 315.7 5944.0 78447 53108

20 2,8 -Diazo bicyclo Nonae 6000 345.8 131.5 6557.7 52727 20046 21 2,3,4,5-Bis-O- (1- methylethylidene)

-b-D-fructopyranose 6000 217.3 192.0 6522.4 33323 29442

22 2- Acetyl Ethoxy acetyl methoxy ether

80 5.9 1.1 86.6 68080 12702

23 N,N-Carbonyl di imidazole 0 0 0 0 0 0 24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-

Tert-Butylcarbonyl Amino 1,6-diohenyl

3263.6 98.8 45.5 3440.8 28715 13233

25 Trans-4- (4-chlorophenyl)-cyclohexane carboxylic acid

2524 177.6 39.1 2740.9 64790 14264

26 Guanine 400 115.8 168.5 1742.3 66440 96721 27 Poly allyl amine HCl 3200 51.8 5.1 3271.8 15825 1547 28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-

flurophenyl)-6-isopropyl-2-(N- 4808.7 286.7 126.0 5184 55313 24307



methyl methane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2- dimethyl-1,3-dioxane -4-yl-) acetate

29 5-Cyano Phthalide 2300 20.0 68.2 2348 8518 29035 30 1,1-Cyclohexane diacetic acid 5588.7 72.7 353.4 5244.2 13854 67393 31 Carbamyl Methyl-5- Methyl

hexanoic acid 777.3 52.9 42.4 695.4 76056 60987

32 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine

1250.2 79.5 108 1411.2 56356 76550

33 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2- pyrimidine amine

3400 116.9 102.7 3708.9 31513 27688

34 4-[(4-Methyl piperazin-1-yl) methyl] benzoic acid DiHCl

2154.6 50.5 46.7 2201.1 22948 21206


7500 286.1 192.9 7940.5 36032 24296

Total Worst Case: 20 Products on Campaign basis

91274.3 5521.1 4027.2 102556.5 53835 39268



Table 2.41 Process Effluents - Quality and Quantity – Stage Wise Amlodipine Besylate

1 Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD

I 3528.4 230 220.7 3894.1 59064 56675 Total 3528.4 230 220.7 3894.1 59064 56675

Bupropion


I 3200 360 70.6 3601.1 99969 19617 II 0 0 0 0 Total 3200 360 70.6 3601.1 99969 19617

Clopidogrel


I 1800 37.8 141.8 2048.5 18436 69246 II 1500 96.5 63.1 1659 58156 38053 Total 3300 134.2 205 3707.5 36210 55288

Desvelofloxin


I 3000 9.6 148.5 3155.6 3040 47068 II Total 3000 9.6 148.5 3155.6 3040 47068

Divolproex Sodium


I 0 0 0 0 0 0 II 0 III 1.2 34.4 34121 0 Total 0 1.2 0 34.4 34121 0

Dulaxetine HCl


I 1100 46.8 52.4 1191 39258 43967 Total 1100 46.8 52.4 1191 39258 43967

Esomeprazole MgTrihydrate


I 4833.5 241.3 146.7 5235.5 46081 28012 Total 4833.5 241.3 146.7 5235.5 46081 28012



Glimepiride


I 1200 32 33 1260.1 25395 26167 Total 1200 32 33 1260.1 25395 26167

Mesalamine


I 3600 312.3 65.7 4007.8 77931 16383 Total 3600 312.3 65.7 4007.8 77931 16383

Metaprolol 10 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 2000 104.5 2136.1 48902 II 1300 12.7 1305.2 III Total 3300 104.5 12.7 3441.3 30355 3679

Pantoprazole Na 11 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 3445 453.3 43.6 5055.7 89666 8634 Total 3445 453.3 43.6 5055.7 89666 8634

12.Pragabalin 12 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 3578.7 307.6 228.9 4214.5 72980 54312 Total 3578.7 307.6 228.9 4214.5 72980 54312

Rosuvastatin 13 Stage Quantity (Kg/Day) Concentration(mg/l)


Sertraline HCl 14 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 3500 111.3 338.7 3872 28754 87488 Total 3500 111.3 338.7 3872 28754 87488



Tramadal 15 Stage Quantity (Kg/Day) Concentration(mg/l)


Valaciclovir 16 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 2528.8 219.2 222.7 3440.6 63696 64735 II 3026.3 34.0 268.6 3209.9 10590 83678 Total 5555.1 253.1 491.3 6650.5 38064 73878

4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid

methyl ester


I 2500 192.2 12.9 2805.1 68514 4604 II 1500 132.4 32.9 1760.5 75200 18697 III 2500 203.5 9.4 2949.6 68983 3170 Total 6500 528.0 55.2 7515.2 70264 7343

N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine 18 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 1200 32 104.3 1361.7 23500 76564 II 1500 90.9 18.4 1703.4 53358 10826 Total 2700 122.9 122.7 3065.1 40094 40030

2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-hydroxypropyl] phenyl]-2-

propanol. 19 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 1300 146.2 180.7 2100.6 69580 86039 II 3004.8 320.1 134.9 3843.3 83293 35110 Total 4304.8 466.3 315.7 5944 78447 53108

2,8 -Diazo bicyclo Nonae 20 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I II 3000 65.0 131.5 3205 20281 41015 III 3000 280.8 3352.7 83743 0 IV Total 6000 345.8 131.5 6557.7 52727 20046



2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 21 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 6000 217.3 192 6522.4 33323 29442 Total 6000 217.3 192 6522.4 33323 29442

2- Acetyl Ethoxy acetyl methoxy ether 22 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 80 5.9 86.6 68080 0 Total 80 5.9 0 86.6 68080 0

1,1 Carbonyl di imidazole 23 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I Total 0 0 0 0

(2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-diohenyl 24 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 1113.6 96.3 23.7 1266.5 76044 18745 II 650 2.5 12.8 665.3 3743 19227 III 1500 9 1509 0 5964 Total 3263.6 98.8 45.5 3440.8 28715 13233

Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid 25 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 500 43 21.7 580.6 74134 37440 II 2024 134.5 17.4 2160.4 62279 8036 Total 2524 177.6 39.1 2740.9 64790 14264

Guanine 26 Stage Quantity (Kg/Day) Concentration(mg/l)


Poly allyl amine HCl 27 Stage Quantity (Kg/Day) Concentration(mg/l)




Tert-butyl 2-((4R,6S) -6-((E)-2-(4-(4- flurophenyl)-6- isopropyl-2- (N- methylmethane sulfonamido)Pyrimidin - 5-yl) vinyl)-2,2- dimethyl-1,3-dioxane-4-yl-) acetate


I 1508.7 30.0 36.9 1569.7 19112 23484 II 1800 126.4 3.8 1936.4 65287 1946 III 1500 130.3 85.4 1677.8 77670 50883 Total 4808.7 286.7 126.0 5184.0 55313 24307

5-Cyano Phthalide 29 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 2300 20.0 68.2 2348.0 8518 29035 II III Total 2300.0 20.0 68.2 2348.0 8518 29035

1,1-Cyclohexanediacetic acid 30 Stage Quantity (Kg/Day) Concentration(mg/l)


Carbamyl Methyl-5-Methyl hexanoic acid 31 Stage Quantity (Kg/Day) Concentration(mg/l)


2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 32 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 650.2 19.5 60.3 709.4 27531 85029 II 600 60 47.7 701.8 85493 67979 Total 1250.2 79.5 108 1411.2 56356 76550

N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine 33 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I 2800 116.9 77.7 3040.6 38439 25551 II 600 25 668.3 0 37410 Total 3400 116.9 102.7 3708.9 31513 27688

4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid dihydrochloride 34 Stage Quantity (Kg/Day) Concentration(mg/l)




2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide 35 Stage Quantity (Kg/Day) Concentration(mg/l)

Water Input TDS COD Total Effluent TDS COD I II 5000 51.1 46.4 5091.9 10037 9110 III 2500 235.0 146.5 2848.6 82496 51441 Total 7500 286.1 192.9 7940.5 36032 24296

2.4.1.1 Process Description and Technical Specification of Effluent Treatment System

The Effluent management system is developed to ensure `Zero Liquid Discharge’.

Segregation of effluents is an integral part that facilitates effective treatment of various

effluent streams. The effluents are segregated into two streams; High COD/ TDS and Low

COD/ TDS streams.

The High TDS/ COD Effluents

The treatment system for treating High TDS/ COD effluents consists of Equalization,

Neutralization, Settling tank, Stripper, Multiple Effect Evaporator (MEE) followed by

Agitated Thin Film Dryer (ATFD). The organic distillate from the stripper is sent to cement

plants for co-incineration and aqueous bottom from stripper is sent to MEE followed by

ATFD for evaporation. The condensate from the MEE and ATFD are sent to ETP

(Biological). Salts from ATFD are disposed to TSDF.

The Low TDS/ COD Effluents:

These effluents along with the condensate from MEE and ATFD are treated in primary

treatment consisting of equalization, neutralization, and primary sedimentation followed by

secondary biological treatment consisting of aeration tank and clarifier.

The treated effluents after biological treatment are subjected to tertiary treatment in a

reverse osmosis (Double RO) system. Permeate from RO is reused for cooling tower and

rejects are sent to MEE followed by ATFD. Sludge from various units of Biological treatment

are thickened in sludge handling system and sent to TSDF. Schematic diagram of effluent

treatment system is presented in Fig 2.36. Details of treatment facilities are presented in



Table 2.42. Technical specifications of effluent treatment system are presented in Table 2.43

and 2.44 respectively.

Table 2.42 Details of Treatment Facilities S.No Description Capacity of Unit (KLD)

Installed Capacity

Total after Expansion

Operating Volume

1 Stripper 10 135 113.3 2 Multiple Effect Evaporator 10 200 161.2 3 Agitated Thin Film Dryer 5 50 39.8 4 Biological Treatment Plant 25 250 191 5 Reverse Osmosis Plant - I 20 250 191 6 Reverse Osmosis Plant - II 70 57.3



Strip

per

Multip

le Effec

t Ev

apor

ator

Agita

ted Th

in

Film

Dryer

Salts

to TSD

F

Settlin

g tank

Equa

lization

&

Neu

tralization

Org

. Dist

illate

to

Cemen

t Ind

./TSD

F

Org

anic

Distillate

High TD

S/CO

D

CondensateLo

w TDS

&

COD

Scre

enCh

ambe

r

Slud

ge

Drying

Bed

Oil

Skim

mer

Equa

lization

&

Neu

tralization

Aeratio

nTa

nkClarifier

Holding

Tank

Filte

rs

Trea

ted W

ater

St

orag

e Ta

nk

Filte

r Pre

ss

Slud

ge Cak

e to

TS

DF

Doub

le

RO Plant

Recy

cle W

ater

Co

llection

Sump

To C

oolin

g To

wer

s

Rejects

Scru

bber

Effluen

t, DM

/RO Rejec

ts

To M

EE

Slud

ge to

TSDF

Fig

2.36

Sch

emat

ic D

iagr

am o

f Eff

luen

t Tre

atm

ent S

yste

m



Table 2.43 Technical Specifications of Effluent Treatment System after Expansion S.No Description Unit After

Expansion Stripper

1 Design Capacity KLD 135 2 Feed Rate Kg/hr 4000-6000 3 Specific Gravity of Feed ≈ 1.03 4 Initial Feed COD PPM 20000-50000 5 Feed Total Solid % 2.0-4.0 6 High Heating Temperature OC 95 – 100 7 High COD Condensate recovery LPH 150-200 8 Dry Saturated Steam requirement at 3.0Kg/cm2 (g) TPH 0.8-1.2 9 Cooling Water circulation rate for condenser m3/hr 1.2-2.5 10 Cooling Water Inlet Temperature OC 30 – 32 11 Cooling Water Outlet Temperature OC 38 – 40

Multiple Effect Evaporator (MEE) 1 Design Capacity KLD 200 2 Feed Rate Kg/hr 7000-9000 3 Feed Concentration mg/l 30000-70000 4 Feed Temperature OC 30 5 Initial Solids % 5.0-8.0 6 Solids in Concentrate % 35.0-40.0 7 Concentrate Output Kg/hr 1500-2500 8 Water Evaporation Rate Kg/hr 5000-8000 9 Designed Water Evaporation Rate Kg/hr 6000 10 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) TPH 3.0-4.0 11 Cooling Water Circulation Rate at 30 – 32OC m3/hr 10.0-15.0 12 Cooling Water Inlet Temperature OC 30 – 32 13 Cooling Water Outlet Temperature OC 38 – 40

Agitated Thin Film Dryer (ATFD) 1 Designed Capacity KLD 50 2 Feed Rate Kg/hr 1500-2500 3 Initial Feed Solid Content % 35.0-40.0 4 Final Moisture in Dry Bag-gable Product % 2.0-3.0 5 Water Evaporation Rate Kg/hr 1000-1500 6 Designed Water Evaporation Kg/hr 1200 7 Solid Output in Bag-gable form at 5 – 6% moisture Kg/hr 600-800 8 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) Kg/hr 100-150 9 Cooling Water Circulation Rate at 30 – 32OC m3/hr 0.1-0.2 10 Cooling Water Inlet Temperature OC 30 – 32 11 Cooling Water Outlet Temperature OC 38 – 40



Table 2.44 Technical Specifications of Biological Treatment Plant - Proposed Data After Expansion Flow from MEE + ATFD : 146.5 KLD Boiler Blow down : 10.0 KLD Cooling Tower Blow down : 26.0 KLD Domestic : 8.5 KLD Total Flow to Neutralization tank : 191 KLD Design Capacity : 250 m3/day Flow : 191 m3/day BOD : 458 mg/l COD : 4589 mg/l Total Dissolved Solids : 513 mg/l BOD load : 88.5 kg/day COD load : 877 kg/day Total Dissolved Solids : 98 kg/day Neutralization Tank Average flow : 20.2 m3/hr Hydraulic retention time : 12 hrs. at peak flow Volume : 250 m3 Tank : 2 no. Proposed based on Daily flow. Aeration Tank - 1 BOD(yo) : 458 mg/l % of BOD removed : 80 BOD Load : 17.7 kg/day COD : 4589 mg/l COD Load : 877 kg/day Outlet BOD : 97 mg/l MLSS : 6000 mg/l F/M ratio : 0.18 Flow : 250 m3/day Volume of the Tank : 191 m3 Check for Detention time : 22.6 Hours (12 - 24) Assuming depth : 3.5 m (4.0+0.5 F.B) Area of the tank : 67.13 m2 Width of the tank : 8.19 m Length of the Tank : 4.10 m BOD5 load in the aeration tank : 206.37 Oxygen is required for every Kg of BOD5 to be removed

: 2.00 kgs

Oxygen requirement for areation : 412.74 kg/day O2 in Air % : 0.21 % Density of Air : 1.20 Oxygen requirement : 50.00 m3/kg O2/day Air Required : 20635.6 m3/day



: 502.2 cfm Consider 35% excess considering the air required in the equalization tank. Total air required : 684.52 Kg O2/day Clarifier - 1 Design quantity : 250 m3/m2-day Surface loading rate of average flow : 12 m2 Surface area provided : 20.8 m length of the tank (2l=b) : 4.56 m (Say 4.5 m) Width of the tank : 2.28 m (Say 2.5 m) Aeration Tank - 2 BOD(yo) : 144 mg/l % of BOD removed : 80 BOD Load : 29.3 kg/day COD : 288 mg/l COD Load : 59 kg/day Outlet BOD : 29 mg/l MLSS : 5500 mg/l F/M ratio : 0.18 Flow : 250 m3/day Volume of the Tank : 227.3 m3 Check for Detention time : 21.8 Hours (12 - 24) Assuming depth : 3.5 m (4.5+0.6 F.B) Area of the tank : 64.94 m2 Width of the tank : 8.06 m Length of the Tank : 4.03 m BOD5 load in the aeration tank : 29.25 Oxygen is required for every Kg of BOD5 to be removed

: 2.00 kgs

Oxygen requirement for aeration : 58.51 kg/day O2 in Air % : 0.21 % Density of Air : 1.20 Oxygen requirement : 50.00 m3/kg O2/day Air Required : 2925.29 m3/day : 71.87 cfm Consider 35% excess considering the air required in the equalization tank. Total air required : 97.03 Kg O2/day Clarifier - 2 Design quantity : 250 m3/m2-day Surface loading rate of average flow : 12 m2 Surface area provided : 20.8 m length of the tank (2l=b) : 4.56 m (Say 4.5 m) Width of the tank : 2.28 m (Say 2.5 m)



Holding tank The flow from the each individual settling tank i.e., the supernatant liquid is let into the respective Pre-Filtration Tank, which has a minimum 8 hours holding capacity. This tank is provided to hold the treated effluent and give an even flow to the pressure sand filter. Average flow : 20.8 m3/hr Peak factor : 2 m3/hr Peak flow : 41.7 m3/hr Provide min 1.5 hours holding capacity. Hence required volume of the tank : 62.5 m3 Pressure Sand Filter: Vertical down flow type with graded/sand bed under drain plate with polysterene strains. Flow : 250 m3/day Rate of filtration assumed as : 15 m3/m2/hr Requirement of treated water for usage in 20 hrs : 12.5 m3/hr Dia of filter of 1 nos. : 1030.33 mm Provide a Pressure Sand filter of 1100 mm say 1250 mm dia with sand as media over layer, under drain pipe, laterals face piping etc., Activated Carbon Filter: Vertical down flow type with graded/sand bed under drain plate with polysterene strains. Flow : 250 m3/day Rate of filtration assumed as : 15 m3/m2/hr Requirement of treated water for usage in 20 hrs : 12.5 m3/hr Dia of filter of 1 nos. : 1030.33 mm Provide activated carbon filter of 1100 mm say 1250 mm dia with sand as media over layer, under drain pipe, laterals face piping etc., Reverse Osmosis -1: Design Capacity : 250 KLD Operating capacity : 191 KLD Recovery : 70% RO Permeate : 133.7 KLD RO rejects : 57.3 KLD Reverse Osmosis - 2: Design Capacity : 70 KLD Operating capacity : 57.3 KLD Recovery : 70% RO Permeate : 40.11 KLD RO rejects : 17.19 KLD



2.4.2 Air Pollution

The manufacturing process consists of reaction, separation and purification. Reactions are

conducted in closed reactors, while separation is conducted in centrifuge, filtration

equipment etc. Purification would be conducted in reactors or filtration equipment. The

transfer of materials will be through closed pipelines. Emissions from process operations are

released from reactions and from down stream operations like drying, crystallization,

filtration etc. The usage of boiler for steam generation and DG sets for emergency power

back up also release emissions.

2.4.2.1 Emissions from Utilities

The sources of air pollution are from proposed 2 x 10 TPH coal fired boiler, existing 1 x 2 TPH

and existing 1 Lakh K.Cal thermic fluid heater. Backup DG sets of 2 x 1000 KVA are

proposed in addition to existing DG sets of 1 x 250 KVA capacity to cater energy requirement

during load shut downs. Bag filter will be provided as air pollution control equipment for 2 x

10 TPH coal fired boilers. DG sets shall be provided with effectivestack height based on the

CPCB formula. The emission rates of PM, SO2, and NOx from each stack presented in Table

2.45. Technical specifications of bag filters for 10 TPH is presented in Table 2.46

Table 2.45 Emission Details of Pollutants from Stack S.

No

Stack Connected to Stack Ht (m)

Dia of stack at top(m)

Temp. of exhaust

gases (0C)

Exit Velocity (m/sec)

Pollutant Emission Rate (g/sec)

SPM SO2 NOx Existing

1 2TPH Coal Fired Boiler

15 1 180 4.5 1.12 0.04 0.13

2 1 lakh K.Cal/hr Thermic Fluid heater

15 0.32 127 7.96 0.16 - 0.004

3 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01 Proposed

1 2X10 TPH Coal Fired Boiler

35 1.45 190 6.05 0.63 0.72 0.3

2 2X1000KVA DG set 10 0.2 180 8 0.01 0.02 0.03 *DG sets will be used during load shut down by TSPDCL.



Table 2.46 Technical Specifications of Bag Filters S.No Application Unit Value/Description

1 Boiler Capacity TPH 10 Fuel Coal

2 Gas Volume m3/hr@170 degC 28000 Gas Temperature Deg C 180 Outlet emission mg/Nm3 <50 Flange to flange pr. drop mmWC 140 Moisture Content % 8.7 No. of Bags 268 Filter area per bag m² 1.72 Total filter area m² 460 Air to cloth ratio m³/min/m² 1.15

3 Bags Diameter ID, mm 160 Length mm 3650 Material Nomex Max. operating temp. degC 190

4 Bag Cleaning Compressed air required Nm3/Hr 5-7 kg/cm2 No. pulse cum solenoid valve 10 Size of pulse valve NB 40

5 Material of Construction Casing MS

a Tube Sheet MS Cage MS Hopper MS

7 Terminal Points Dirty air Inlet of Poppet Valve, Flanged end Clean air Outlet of Bag Filter, Flanged end Dust discharge RALV Compressed air Inlet of Air Header Electricals Power Supply for Timer 230 V Ac



2.4.2.2 Emissions from Process (Terms of Reference No. Sp. TOR (2))

The manufacturing process consists of reaction, separation and purification. The reaction is

conducted in closed reactors, while the separation is conducted in centrifuge, filtration

equipment etc. The purification would be conducted in reactors or filtration equipment. The

transfer of materials is through closed pipelines. Various sources of emissions are identified;

a. Process Emissions The process emissions contain Ammonia, Carbon dioxide, carbon

monoxide, Hydrogen, Hydrogen Bromide, Bromine, Hydrogen Chloride and Sulfur dioxide.

Ammonia, Hydrogen chloride, Hydrogen Bromide, Bromine and Sulphur dioxide are sent to

scrubber in series. Ammonium Chloride from ammonia scrubbing, Sodium chloride from

HCl scrubbing, Sodium bromide from HBr and Bromine Scrubbing and Sodium Bisulfite

from Sulphur dioxide Scrubbing are sent to ETP. The other gases Carbon dioxide and carbon

monoxide are let out into atmosphere following a standard operating procedure, while

Hydrogen gas is let out into atmosphere through a water column. The quantity of process

emissions is presented in Table 2.47. Schematic diagram of Scrubbing system is presented in

Fig 2.37. Technical Specifications of two stage scrubber is presented in Table 2.48.

Table 2.47 Quantity and Mode of Treatment of Process Emissions Product Name Stage Name of Gas Quantity

(Kg/Day) Mode of treatment

Bupropion I

Hydrogen Bromide 529.8 To Scrubber Hydrogen Chloride 14.3 To Scrubber

Desvelofloxin I

Carbon dioxide 41.8 Let out into atmosphere Hydrogen 0.2 Let out into atmosphere

through water column Divolproex sodium I Carbon dioxide 176.8 Let out into atmosphere Esomeprazole Mg I

Hydrogen Chloride 60.1 To Scrubber Hydrogen 0.2 Let out into atmosphere

through water column Rosuvastatin I Hydrogen 1.6 Sertraline Hcl I Hydrogen 5.8 Valaciclovir II Hydrogen 1.2 N2-(1-(S)-ethoxycarbonyl-3-phenylpropyl-N6-trifluoro acetyl)-L-Lysine

II Hydrogen 4.4

2-[2--[3(S)-[3-[2- (7-chloro-2-quinolinyl) ethenyl] phenyl]-3-hydroxypropyl] phenyl]-2- propanol.

I Carbon dioxide 11.6 Let out into atmosphere



(S,S)-2,8-diazabicyclo[4.3.0] nonane

II Hydrogen 0.1 Let out into atmosphere through water column IV Hydrogen 0.4

Aminohydroxy butyloxy diphenylhexane

II

Carbon dioxide 12.8 Let out into atmosphere Hydrogen 0.6 Let out into atmosphere

through water column III Hydrogen 0.1 Trans-4-(4-chlorophenyl) cyclohexane carboxylic acid

II Carbon monoxide 11.7 Let out into atmosphere

Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methyl methane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3- dioxane-4-yl-) acetate

III Bromine 23.4 To Scrubber

5 Cyano Phthalide I

Sulfur dioxide 547.3 To Scrubber Hydrogen Chloride 624.3 To Scrubber

II

Sulfur dioxide 439.2 To Scrubber Hydrogen Chloride 501.0 To Scrubber

1,1-cyclohexane di aceticacid

I

Ammonia gas 566.7 To Scrubber Carbon dioxide 733.3 Let out into atmosphere

3-Carbomylmethyl-5-methyl hexanoic acid

I

Ammonia gas 227.3 To Scrubber Carbon dioxide 352.5 Let out into atmosphere

N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine

II Hydrogen 3.9

Benzoic acid, 4-[(4-methyl-1-piperazinyl) methyl] dihydrochloride

I

Hydrogen Bromide 87.8 To Scrubber Ammonia gas 18.5 To Scrubber

2,3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl]propanamide

I

Sulfur dioxide 62.2 To Scrubber Hydrogen chloride 35.5 To Scrubber



Fig 2.37 Schematic Diagram of Scrubbing System

Table 2.48 Technical Specifications of Two Stage Scrubber Type Packed Tower Scrubber Two Stage MOC PP/FRP 5 mm PP+8mm FRP Air Flow Rate 2500CFM Inlet Temp. 350C Inlet Gas Pressure Atmospheric Batch 24 Hrs Scrubbing medium for IstStage Water 10% NaOH Solution Scrubbing medium for IIndStage Caustic Solution (or) Acid Blower MOC PPFRP Capacity 2500CFM Suction Pressure − 250mmWC Discharge Pressure 60mmWC HP/RPM 5HP/1900RPM Circulation System Flow Rate 15 M3/hr Head 30 Meters Motor Make FLP MOC PP Make Antico Storage/ Recirculation Tank Capacity 3 KL Size 1700mm Dia X 2300mm Ht. MOC PP/FRP



2.4.2.3 Diffuse Emissions

Emissions are also released from various operations of manufacturing like centrifuge,

drying, distillation, extraction etc. These emissions mainly contain volatile contents of the

material sent for processing. The emissions are normally passed through vent scrubber

before releasing into atmosphere to mitigate odour. The emissions from distillation are

passed through condensers, which mitigate odour. Vent condensers in series to reactors,

distillation columns, driers and centrifuge etc. are provided to mitigate VOC emissions

release. Other vents are connected to common headers and scrubbers. The transfer pumps

shall be provided with mechanical seals. The transfer of solvents shall be mainly by closed

pipeline systems, while drum transfer is by using air operated diaphragm pumps in closed

hoods. The charging of solid raw materials shall be by using closed hoppers to avoid dust

emissions and hazard of static electricity. Breather valves shall be provided to storage

tanks. Thermal insulation and condensers will be provided for storage tanks of low boiling

point solvents. The reactor or solvent storage tank vents when not in use shall be kept

closed.

2.4.2.4 Fugitive Emissions

Fugitive emissions are anticipated from equipment leakage and transfer spills. The

periodic maintenance program shall ensure integrity of equipment mitigating the

equipment leakage. The spills however shall be managed by adopting the spill

management scheme as mentioned in the respective MSDS. The fugitive emissions shall be

reduced by closed transfer and handling of all hazardous solvents and chemicals. The

ventilation system provided will reduce the health impact on employees by way of dilution

of work room air and also dispersion of contaminated air.

2.4.2.5 Solvent Use and Recycle (Terms of Reference No. Sp. TOR (1))

Solvents are used for extraction of products and as reaction medium. Solvents constitute

major consumable material of synthetic organic chemical manufacturing, mainly used as

reaction medium. The used solvents constitute major waste stream of synthetic organic

chemical manufacturing. Hence it is proposed to recycle the solvents by distillation for reuse



in process, thereby reducing the total solvent consumption in the plant and reducing the

waste quantity to be disposed. The distillation columns are mainly provided to remove

moisture and impurities from spent single solvents, and mixed solvents. The recycled single

solvents are reused in the process, while the mixed solvents are sold to end users.

Distillation process generates residues which are mainly organic in nature containing

significant calorific value, and can be sent to cement plants for co-incineration as fuel. The

total solvent balance product wise and stage wise is presented in Table 2.49 & 2.50

respectively. Schematic diagram of solvent recovery system is presented in Fig 2.38.

Table 2.49 Total Solvent Balance – Product Wise S.No Product Name Quantity (Kg/Day)

Solvent Quantity

Recovered Fugitive loss

To waste water

Residue

1 Amlodipine Besylate 4250 4033 28.9 27.6 160.5 2 Bupropion HCl 13250 12832.3 57.1 27.5 333.2 3 Clopidogrel Hydrogen Sulfate 7700 7441.5 36.3 44 178.2 4 Desvelofloxin Succinate 4500 4356.5 20 38 85.5 5 Divolproex Sodium 2000 1940.0 5 0 55 6 Dulaxetine HCl 2922 2775.9 23.4 36 86.7 7 Esomeprazole Mg Trihydrate 13072 12478.4 104.6 122.9 366.1 8 Glimepiride 2300 2244.5 12.4 8.1 35 9 Mesalamine 0 0 0 0 0 10 Metaprolol 3500 3395 15.5 0 84.3 11 Pantoprazole Sodium

Sesquihydrate 3850 3726.5 30.8 26.5 66.2

12 Pragabalin 6000 5700 48 180 72 13 Rosuvastatin Calcium 2550 2468 20.4 21.4 40.2 14 Sertraline HCl 5150 4892.5 41.2 154.5 61.8 15 Tramadal 6500 6175 52 195 78 16 Valaciclovir HCl Monohydrate 12349.8 11999.3 55.9 60.3 234.3 17 4-[4-Chloro-1-oxobutyl]-2, 2-

dimethyl phenyl acetic acid 3441.5 3331.8 8.3 6.4 95


4500 4343 22.4 36.7 97.9


6150 5948.8 28 24.2 149.1

20 2,8-Diazo bicyclo Nonane 12450 12054 58.9 0 317.2 21 2, 3, 4, 5-Bis-O- (1- 4950 4702.5 39.6 20.9 187



methylethylidene)-b-D-fructopyranose

22 2-Acetyl Ethoxy acetyl methoxy 0 0 0 0 0 23 (1,1) Carbonyl di imidazole 8500 8287.5 42.5 0 170 24 (2S, 3S, 5S)-2-Amino-3-Hydroxy-

5-Tert-Butylcarbonyl Amino 1, 6-diohenyl

3000 2879.5 18 28.5 74

25 Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid

2450 2365.8 12 23 49.3

26 Guanine 0 0 0 0 0 27 Poly allyl amine HCl 0 0 0 0 0 28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-

(4-flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido)Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate

6850 6576 13.7 68.5 191.8

29 5-Cyano Pthalide 10000 9600 20 28 352 30 1,1-Cyclohexanediacetic acid 8000 7760 20 47.8 172.2 31 Carbamyl Methyl-5-Methyl

hexanoic Acid 3700 3589 5.5 22.3 83.3


2950 2843.5 24.1 25.4 57

33 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine

9000 8730 26.5 79.5 164.1

34 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl

1950 1891.5 4.9 19.5 34.1


4220 4075.2 29.4 42 73.4

Total Worst Case: 20 Products on campaign basis

145585.3 140409.4 678.8 885.5 3586.3



Table 2.50 Total Solvent Balance – Stage Wise S.No Product Name Stage Name of Solvent Quantity (Kg/Day)

Solvent Quantity

Recovered Fugitive loss

To waste water

Residue

1 Amlodipine Besylate I Methanol 1500 1425 12 9 54 Methylene Chloride 1200 1152 8.4 39.6 Ethyl acetate 800 736 3.2 8.8 52 Mono Methyl amine 750 720 5.25 9.8 14.9

2 Bupropion HCl I N-methyl Pyrrolidone 500 482.5 2.5 5 10 Methylene chloride 3000 2910 12 78 Toluene 3200 3104 12.8 83.2 Acetone 750 723.75 3.8 7.5 15 II Acetone 3000 2910 12 15 63 Methanol 2800 2702 14 0 84

3 Clopidogrel Hydrogen Sulfate I Methylene dichloride 800 772 4 24 Ethyl acetate 1000 970 4 5 21 II Ethyl acetate 1500 1448 7.5 15 30 Methyl isobutyl ketone 1200 1164 4.8 6 25.2 Methylene dichloride 2000 1930 10 60 Acetone 1200 1158 6 18 18

4 Desvelofloxin Succinate I Ethyl acetate 1500 1447.5 7.5 15 30 n-hexane 1000 970 4 26 Methanol 1200 1164 4.8 14.4 16.8 Isopropyl alcohol 300 292.5 1.2 3.6 2.7 II Isopropyl alcohol 500 483 2.5 5 10

5 Divolproex Sodium I Methanol 0 0 0 0 0 III Methanol 2000 1940.0 5 55

6 Dulaxetine HCl I Dimethyl sulphoxide 1722 1635.9 13.8 72.3 Ethyl acetate 1200 1140 9.6 36.0 14

7 Esomeprazole Mg Trihydrate I Methanol 2000 1900 16 60 24

Methylene dichloride 5472 5198.4 43.8 229.8



Acetic acid 600 570 4.8 18.0 7.2

Ethanol 2000 1900 16.0 26.0 58

Acetone 3000 2910 24.0 18.9 47 8 Glimepiride I Acetone 1200 1176 6.0 4.2 13.8

Dimethyl formamide 500 482.5 3.0 2.5 12 Methanol 400 392 2.0 1.4 4.6 Methyl isobutyl ketone 200 194 1.4 4.6

9 Mesalamine 10 Metaprolol Succinate II Toluene 1000 970 3 21.8

III Acetone 2500 2425 12.5 0 62.5 11

Pantoprazole Sodium Sesquihydrate I

Acetone 900 873 7.2 5.7 14.1 Ethanol 1200 1164 9.6 7.6 18.8 Methlene dichloride 250 237.5 2 0.8 9.7

Diisopropyl ether 1500 1452 12 12.5 23.6 12 Pragabalin I Isopropanol 2000 1900 16 60 24

Chloroform 4000 3800 32 120 48 13 Rosuvastatin Calcium I Acetone 750 720 6 5.5 18.5

Ethyl acetate 1000 980 8 9.3 2.7 Ethanol 800 768 6.4 6.6 19

14 Sertraline HCl I Ethyl acetate 3000 2850 24 90 36.0 n-Butanol 1500 1425 12.0 45 18 Diisopropyl ether 650 617.5 5.2 19.5 8

15 Tramadal HCl I n-Propanol 3000 2850 24 90 36 Ethyl acetate 3500 3325 28 105 42

16

Valaciclovir HCl Monohydrate

I

Dimethyl amine 2500 2437.5 12.5 25 25 Dimethyl formamide 350 339.3 1.4 9.1

Acetone 2500 2437.5 100 52.5 Ethanol 3000 2925 12 63 II Methanol 1500 1447.5 7.5 15 30 Ethanol 2500 2412.5 12.5 20.3 54.8

17 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid

I DMF 241.5 231.8 0.5 2.4 6.8



Toluene 400 384 0.8 4 11

II Methylene dichloride 800 776 2 22

Toluene 550 533.5 1.4 15

Methanol 600 582 1.5 17

III Methylene dihloride 150 145.5 0.4 4

Toluene 700 679 1.8 19 18 N2-(1-(S)-ethoxy carbonyl-3-phenyl

propyl-N6-trifluoro acetyl-L-lysine I Methanol 2400 2316 12 24 48 II Ethyl acetate 2000 1930 10 12.2 47.8

Ethanol 100 97 0.4 0.5 2 19 2-[2-[3(S)-[3-[2-(7-Chloro-2-

Quinolinyl)-ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol

I Methanol 150 144.8 0.8 1.5 3 Methylene dichloride 2500 2412.5 12.5 5.3 70 Acetonitrile 400 386 2 0.4 12

II Methanol 300 289.5 1.5 3 6 Toluene 1800 1746 7.2 9 38 Hexane 1000 970 4.0 5 21

20 2,8-Diazo bicyclo Nonane I Methanol 750 720 1.5 0 28.5 Toluene 500 485 1.3 14 II Ethyl acetate 2500 2425 7.5 47.5 Methylene dichloride 1200 1164 3.6 32.4 III Tetrahydrofuran 3000 2910 15 75 Toluene 2500 2400 15 85 IV Methanol 2000 1950 15 35

21 2, 3, 4, 5-Bis-O- (1- methylethylidene)-b-D-fructopyranose

I Acetone 800 760 6.4 6.6 27 n-Hexane 1000 950 8 0 42 Toluene 3000 2850 24 12.9 113

Isopropanol 150 142.5 1.2 1.4 5 22 2-Acetyl Ethoxy acetyl methoxy I 23 (1,1) Carbonyl di imidazole I Toluene 8500 8287.5 42.5 0 170 24 (2S, 3S, 5S)-2-Amino-3-Hydroxy-5-

Tert-Butylcarbonyl Amino 1, 6-diohenyl

I Tetrahydrofuran 1000 945 10 13 32.0 II Methanol 500 480 2 6.5 12 III Methanol 1500 1455 6 9 30




I Toluene 400 386 2 4 8 Ethanol 250 241.25 1.3 2.5 5 Monochlorobenzene 500 482.5 2.5 5 10

II Ethanol 1000 965 5 10 20 Toluene 100 97 0.4 0.5 2 Hexane 200 194 0.8 1 4

26 Guanine I 0 0 0 0 0 27 Poly allyl amine HCl I 0 0 0 0 0 28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-

flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate

I Methanol 350 336 0.7 3.5 9.8 Methylene dichloride 750 720 1.5 7.5 21

II Methylene dichloride 1000 960 2 10 28 III Methanol 800 768 1.6 8 22

Toluene 1800 1728 3.6 18 50 DIP 700 672 1.4 7 20

Hexane 600 576 1.2 6 17 Dimethyl sulfoxide 850 816 1.7 8.5 24

29 5-Cyano Pthalide I Toluene 2800 2688 5.6 28 78.4 II Methanol 1000 960 2 0 38 Ethylene dichloride 3500 3360 7 0 133 III Methanol 200 192 0.4 0 8 Di Methyl Formamide 2500 2400 5 0 95

30 1,1-Cyclohexanediacetic acid I Isopropyl Alcohol 5000 4850 12.5 35.5 102 Toluene 3000 2910 7.5 12.3 70

31 Carbamyl Methyl-5-Methyl hexanoic Acid

I Toluene 2500 2425 2.5 10.3 62.3 Ethylacetate 1200 1164 3 12 21


IV Tri ethylamine 200 194 0.5 2 4 Methylene chloride 600 582 2.1 1.9 14

Di isopropyl ether 400 388 1.4 4 7

V Toluene 500 475 10 5 10

Dichloro methane 850 824.5 2.1 8.5 15

Isopropyl alcohol 400 380 8 4 8




I n-butanol 2500 2425 6.3 20.3 49 Isopropyl alocohol 2000 1940 7 14.2 39

Methanol 2000 1940 7 20 33 II Methanol 2500 2425 6.3 25 44

34 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl

I Triethyl amine 150 145.5 0.4 1.5 2.6 Toluene 1800 1746 4.5 18 32


I Dimethylformamide 20 19.2 0.2 0.6 II Toluene 1000 970 2.5 10 18

N,N-Dimethyl acetamide

1500 1455 5.3 15 25

III Chloroform 800 776 2 8 14 Toluene 600 570 12 6 12 Dimethyl formamide 300 285 7.5 3 5



Fig

2.38

Sch

emat

ic D

iagr

am o

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vent

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very

Sys

tem



2.4.3 Solid Waste

Solid wastes are generated from the process, solvent distillation, wastewater treatment and

utilities. The effluent treatment system generates stripper distillate, ATFD salts and ETP

sludge. The process operations generate process residue, filter media, used catalysts,

activated carbon and inorganic residue. The recycling operation of distillation generates

solvent residue and spent mixed solvents. The utilities i.e., coal fired boiler generates ash

while DG sets generate waste oil and used batteries. All the wastes except coal ash are

considered hazardous. The other non hazardous wastes are container, packing material,

empty drums etc. The containers and drums are detoxified before disposing to authorized

buyers. The hazardous wastes of process residue, stripper distillate, solvent residue, and

activated carbon are sent cement plants for co-incineration, thereby reducing the load on

TSDF facility and reducing consumption of non renewable resource of coal in cement plant

kilns. Mixed solvents shall be sent to authorized recyclers/cement plant for co-incineration

while spent solvents are recovered within plant premises. The inorganic wastes, filter media,

used catalysts, salts from ATFD, and ETP sludge are sent to TSDF facility located at

Dundigal, Ranga Reddy district. The waste oil and used batteries are sold to authorized

recyclers. Coal ash is sold to brick manufacturers in the local area. The process wastes are

compiled for each product in Table 2.51. The stage wise generation process wastes is

presented in Table 2.52. The quantity of solid waste generated in the plant and the disposal

practice is presented in Table 2.53.



Table 2.51 Solid Wastes Generated from Process – Product Wise S.No

Name of Product

Quantity (Kg/Day) Organic Residue

Inorganic Residue

Solvent Residue

Spent Carbon

Hyflow Pd/C Total

1 Amlodipine Besylate 161.8 12.0 160.5 20 354.3 2 Bupropion HCl 135.3 333.2 30 498.5 3 Clopidogrel Hydrogen

Sulfate 199.7 54.0 178.2 40 471.9

4 Desvelofloxin Succinate

50.2 85.5 0 15 150.7

5 Divolproex Sodium 75.4 55.0 30 160.4 6 Dulaxetine HCl 114.2 86.7 20 220.9 7 Esomeprazole Mg

Dihydrate 116.3 366.1 30 512.4

8 Glimepiride 54.8 35.0 10 99.8 9 Mesalamine 27.3 53.1 0.0 20 100.4 10 Metaprolol Succinate 67.6 84.3 151.9 11 Pantoprazole Sodium

Sesquihydrate 34.4 250.0 66.2 30 380.6

12 Pragabalin 304.8 72.0 376.8 13 Rosuvastatin Calcium 26.8 40.2 25 92.0 14 Sertraline HCl 170.4 61.8 20 252.2 15 Tramadal 275.9 269.4 78.0 30 653.3 16 Valcyclovir

Hydrochloride Monohydrate

463.6 15.0 234.3 25 15 30 782.9

17 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid methyl ester

99.2 62.6 95.0 256.7


760.5 97.9 50 908.4


117.8 149.1 50 316.9

20 2,8-Diazo bicyclo Nonane

258.9 835.0 317.2 35 1446.1

21 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose

187 187.0

22 2- Acetyl Ethoxy acetyl methoxy ether

414.8 0.0 414.8



23 N,N-Carbonyl di imidazole

2238.6 170.0 2408.6

24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-diohenyl

159.5

74.0 28 20 281.5


21.0 49.3 70.3

26 Guanine 1198.5 2199.4 0.0 3397.9 27 Poly allyl amine HCl 50.4 0.0 50.4 28 Tert-butyl 2-((4R,6S)-6-

((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido)Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate

247.7 191.8 439.5

29 5-Cyano phthalide 862.3 352.0 8 1222.3 30 1,1-

Cyclohexanediacetic acid

517.3 172.2 689.5

31 Carbamyl Methyl-5-Methyl hexanoic Acid

202.6 12.0 83.3 297.8


97.0 8.0 57.0 10 5 177.0


303.6 164.1 50 517.6


128.1 34.1 162.2


108.0 73.4 181.4

Total (Worst Case Max 20 Products on Campaign basis)

9121.7 3770.4 3586.3 368 78 200 16371.7



Table 2.52 Solid Waste Generated from Process – Stage Wise 1 Amlodipine Besylate

Stage Quantity(Kg/Day) Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon

Hyflow Catalyst Total

I 107.9 12 160.5 20 300.4 Total 107.9 12 160.5 20 300.4

2 Bupropion HCl Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 66 186.2 252.2 II 69.3 147 30 246.3

Total 135.3 0 333.2 30 498.5 3 Clopidogrel Hydrogen Sulfate


Inorganic Residue

Solvent residue

Spent Carbon


I 97.5 54 45 196.5 II 102.2 133.2 40 275.4

Total 199.7 54 178.2 40 471.9 4 Desvelofloxin Succinate


Inorganic Residue

Solvent residue

Spent Carbon


I 40.2 75.5 15 130.7 II 10 10 20

Total 50.2 0 85.5 0 15 150.7 5 Divolproex Sodium


Inorganic Residue

Solvent residue

Spent Carbon


I 0 0 0 II 23.4 23.4 III 52.1 55 30 137.1

Total 75.4 0 55 30 0 0 160.4 6 Dulaxetine HCl


Inorganic Residue

Solvent residue

Spent Carbon


I 114.2 86.7 20 220.9 Total 114.2 0 86.7 20 220.9



7 Esomeprazole Mg Dihydrate Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 116.3 366.1 30 512.4 Total 116.3 0 366.1 30 512.4

8 Glimepiride Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 54.8 35 10 99.8 Total 54.8 0 35 10 99.8

9 Mesalamine Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 27.3 53.1 20 100.4 Total 27.3 53.1 0 20 100.4

10 Metaprolol Succinate Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 10.3 10.3 II 13.8 21.8 35.6 III 43.5 62.5 106

Total 67.6 0 84.3 0 0 0 151.9 11 Pantoprazole Sodium Sesquihydrate


Inorganic Residue

Solvent residue

Spent Carbon


I 34.4 250 66.2 30 380.6 Total 34.4 250 66.2 30 380.6

12 Pragabalin Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 304.8 72 376.8 Total 304.8 0 72 0 376.8

13 Rosuvastatin Calcium Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 26.8 40.2 25 92.0 Total 26.8 0 40.2 25 92.0



14 Sertraline HCl Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 170.4 61.8 20 252.2 Total 170.4 0 61.8 20 252.2

15 Tramadal Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 275.9 269.4 78 30 653.3 Total 275.9 269.4 78 30 653.3

16 Valcyclovir Hydrochloride Monohydrate Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 197.1 15 149.6 15 376.7 II 266.4 84.8 25 30 406.2

Total 463.6 15 234.3 25 15 30 782.9 17 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid methyl ester


Inorganic Residue

Solvent residue

Spent Carbon


I 40.8 18 58.7 II 24.5 18.0 53.6 96.1 III 33.9 44.6 23.4 101.8

Total 99.2 62.6 95.0 0.0 0.0 0.0 256.7 18 N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine


Inorganic Residue

Solvent residue

Spent Carbon


I 269.1 48 317.1 II 491.4 49.9 50 591.3

Total 760.5 0 97.9 0 0 50 908.4

19 2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-hydroxypropyl] phenyl]-2-propanol. Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 13 84.3 97.3 II 104.7 64.8 50 219.5

Total 117.8 0 149.1 0 50 0 316.9



20 2,8 -Diazo bicyclo Nonae Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 79.9 42.3 122.2 II 3.5 79.9 15 98.4 III 11.6 835 160 1006.6 IV 163.9 35 20 218.9

Total 258.9 835 317.2 0 0 35 1446.1 21 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose


Inorganic Residue

Solvent residue

Spent Carbon


I 0 187 187 Total 0 0 187 0 187

22 2- Acetyl Ethoxy acetyl methoxy ether Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 414.8 414.8 Total 414.8 0 0 0 414.8

23 N,N-Carbonyl di imidazole Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 2238.6 170 2408.6 Total 2238.6 0 170 0 2408.6

24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-diohenyl Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 12.9 32 10 54.9 II 81.6 12 8 101.6 III 65 30 10 20 125

Total 159.5 0 74 28 0 20 281.5 25 Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid


Inorganic Residue

Solvent residue

Spent Carbon


I 14.9 23 37.9 II 6.1 26.3 32.4

Total 21.0 0.0 49.3 0.0 0.0 0.0 70.3



26 Guanine Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 1198.5 2199.4 3397.9 Total 1198.5 2199.4 3397.9

27 Poly allyl amine HCl Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 50.4 50.4 Total 50.4 0 0 0 50.4

28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido)Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 1.5 30.8 32.3 II 3.7 28 31.7 III 242.6 133 375.6

Total 247.7 0 191.8 0 0 0 439.5 29 5-Cyano Phthalide


Inorganic Residue

Solvent residue

Spent Carbon


I 112.9 78.4 191.3 II 324.9 171 495.9 III 424.5 102.6 8 535.1

Total 862.3 0 352.0 0 8 0 1222.3 30 1,1-Cyclohexanediacetic acid


Inorganic Residue

Solvent residue

Spent Carbon


I 517.3 172.2 689.5 Total 517.3 0 172.2 689.5

31 Carbamyl Methyl-5-Methyl hexanoic acid Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 202.6 12 83.3 297.8 Total 202.6 12 83.3 297.8



32 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 21.9 24.1 10 5 61 II 75.1 8 32.9 115.9

Total 97 8 57 10 5 177 33 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine


Inorganic Residue

Solvent residue

Spent Carbon


I 104.4 120.3 224.7 II 199.1 43.8 50.0 292.9

Total 303.6 0 164.1 0 0 50.0 517.6 34 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid dihydrochloride


Inorganic Residue

Solvent residue

Spent Carbon


I 128.1 34.1 162.2 Total 128.1 0 34.1 162.2

35 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide Stage Quantity(Kg/Day)

Organic Residue

Inorganic Residue

Solvent residue

Spent Carbon


I 9.3 0.6 9.9 II 33.2 42.3 75.5 III 65.5 30.5 96

Total 108.0 0 73.4 0 0 0 181.4



Table 2.53 Total Solid Waste Generated and Mode of Disposal S.No Description Units Quantity Mode of

Treatment/Disposal Permitted After Expansion

1 Solvent residue TPD 0.033 3.58 Sent to TDSF/Cement Plants for Co-incineration 2 Process Organic

residue TPD 9.12

3 Stripper Distillate KLD 3.4 4 Spent Carbon Kg/day 33.33 368 5 Spent Solvents KLD 1 126.4 Recovered within the

plant premises. 6 Spent Mixed

Solvents KLD 0.66 14 Sent to authorized

recovery units/Cement plants for co-incineration

7 Inorganic residue TPD 3.77 Sent to TSDF 8 Hyflow Kg/day 78 9 Catalyst Kg/day 200

10 Evaporation salts TPD 1.33 11.92 11 ETP Sludge TPD 0.65 12 Ash from Boiler TPD 40 Sold to Brick

manufactures 13 Detoxified

containers No.s/ month

50 650 Sold to authorized vendors

14 Waste oil KLPA 5.88 Sent to Authorized Recyclers 15 Used batteries No.s/Yr 20

2.4.4 Noise Pollution

Noise is anticipated from motors, compressors and DG set. The DG shall be kept in a

separate enclosed room with acoustic enclosure. The motors and compressors shall be

provided with guards and shall be mounted adequately to ensure the reduction of noise and

vibration. The employees working in noise generating areas shall be provided with

earmuffs. The employees shall be trained in the mitigation measures and personal

protection measures to be taken to avoid noise related health impacts.

Hazelo Lab Pvt.Ltd. Environmental Impact Assessment Report


CHAPTER 3.0 BASELINE ENVIRONMENTAL STATUS

3.1 Introduction

Collection of base line data is an integral aspect of the preparation of Environmental

Impact Assessment Report. Baseline data reflects the present status of environment

before initiation of any activity of project. The possible effects due to proposed

expansion of manufacturing of M/s. Hazelo Lab Pvt.Ltd., are estimated and

superimposed on the compiled baseline data subsequently to assess environmental

impacts. The study was conducted in the impact area; 10 km radius area surrounding

the project site, during December 2016 - February 2017. Studies were undertaken to

generate baseline data of Micrometeorology, Ambient air quality (AAQ), water

quality, noise levels, flora and fauna, land use, soil quality and socio-economic status

of the community were collected.

3.2 Land Environment

Land and soil constitute the basic components of physical environment. The location

of industrial project may cause changes in land, land use, soil and denudational

processes in different intensities contingent on sptial proximity of the activity and

receptors. Land and soil may get altered within the vicinity of 5 km radius and to a

lesser extent upto 10 km radial distance due to the proposed expansion project.

3.2.1 Physiography

The project site is located at Survey Number 240, 242, 243, 247, 248 and 249,

Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri District, Telangana.

The site is located at the intersection of 170 17’ 17” (N) latitude and 780 50’ 46” (E)

longitude. The site elevation above mean sea level (MSL) is 407 m. The site is

surrounded by open land in north, west and south directions and SVR Laboratries

Pvt. Ltd., in east direction. The nearest habitation form the site is Antammagudem

located at a distance of 0.65 km in east direction. The main approach road is

Dothigudem – NH9 at a distance of 0.2 km in west direction. National Highway-9 is

at a Distance of 2.8 Km in Southwest Direction to the site. The nearest Town is

Choutuppal at a distance of 5.6 km in southeast direction and nearest airport is

Shamshabad located at a distance of 44 km in southwest direction. Chinna Musi River

is passing from NW to NE at a Distance of 5.8 Km in NW direction to the site. There



are seven reserve forests in the study area; Lakkaram RF at a distance of 1.2 km in

south direction, Chauttuppal RF at a distance of 4.8 km in northwest direction,

Malkapuram RF at a distance of 2.2 km in west direction, Hafeezpura RF at a distance

of 7 km in southwest direction, Ailaupur RF at a distance of 6.7 km in southwest

direction, Meharnagar RF at a distance of 5.3 km in northwest direction and Jalalpur

RF at a distance of 6.7 km in northwest direction are in the impact area. There is no

National Park, Wildlife sanctuary, ecologically sensitive area, critically polluted area

and interstate boundary within the impact area of 10 km. The slope of the region is

from northeast to southeast direction. The area has mainly single crop agricultural

lands irrigated by tube wells. The Site Location photographs are presented in Figure

3.1. The Base map of the study area is presented in Figure 3.2.

Figure 3.1 Site Photograph – Hazelo Lab Pvt. Ltd.

(Terms of Reference No. 4(vii))



3.2.2 Geology (Terms of Reference No. 4(x))

Geology and general configuration of the Area

The study area is underlain by various geological formations like Archaen

Crystallines, Deccan Traps, Puranas, Laterites, and River Alluvia. The area is occupied

by peninsular gneissic complex of the Archean age comprisssing pink and grey

granites, granitic sanded geneisses, migmatities, pegmatites, quartz veins and dolerite

dykes. They occur in the form of domes, scarpes, massive, columnar blocks and ‘tors’

etc. scattered over a flat undulating country. Both massive granites and gneisses are

intruded positioned, dolerite dykes and quartzite and pegmatitic reefs.

The deccan trap constitute a number of layers of varying texture and thickness. The

traps are weathered and vesicular. Weathered basalts have medium permeability and

vesicular basalts have relatively high permeability. Small areas of basaltic strata are

present as “outliers” in granitic terrain. Laterites are found capping the weathered

basalts.

The Unconsolidated materials in granitic terrain consist of the “in-situ” weathered

remains of parent bedrock for the most part of the district. Those materials (including

soils) present at the ground surface over upland areas and valley sides range in the

thickness from few centimeters to 25 m, the average thickness is approximately 22 m.

Along the flood plains of stream courses weathered materials are overlain by

transported sediments, the combined thickness of which range up to 30m. The

average thickness is approximately 18m. In basaltic terrain, unconsolidated materials

comprise lateritised clay, weathered basalt inter-trappean clays, and alluvial

sediments. Thickness of weathered basalts capped by laterites range upto 30m.

Whereas the thickness of weathered basalts exposed at the ground surface

approximates to around 6m.

3.2.3 Hydrogeology (Terms of Reference No. 4(x))

Drainage Pattern

Hydrogeologically the study area can be grouped under hard rocks occupied by

granite and granitic gneisses; the ground water occurs under confined conditions in

the weathered mantle and under semi confined conditions in the joints, fractures,

crevices etc. of the fresh rock below. It’s occurrence is controlled by the intensity and



depth of weathering and by the presence of the joints and fractures, which vary from

place to place. The open place available for water to accumulate in fresh rock is

extremely limited, while the weathered zone, which is more porous carrying most of

the water that is available for development. The depth to water table in wells is

governed to a large extent by the topography, the water levels being shallow in wells

located in valleys than those located on high grounds.

The open wells existing in the study area are tapping weathered zone and range in

depth from 5 to 18 meters below ground level. Most of the wells fall within the depth

range of 5 to 10 meters, and about 30 percent of wells fall within the depth range of 10

to 15 meters. The yield of dug wells with 10 to 15 m depth ranges from 80 to 180

m3/day. The wells are capable of sustained yield of about 500 lpm with a draw down

ranging from 1 to 6 meters. The yield of bore wells range from 4000 to 20000

liters/hour.

In areas of massive and poorly weathered rocks the safe well yield is less than 1

ha.m/year. Lower values occur in uplands where the transitivity, effective available

draw down and maximum area of zone of influence of pumping wells are low,

conversely, highest values occur where those independent variables are highest.

3.2.4 Soils

Soil may be defined as a thin layer of earth’s crust that serves as a natural medium for

the growth of plants. It is the unconsolidated mineral matter that has been subjected

to and influenced by genetic and environmental factors such as parent materials,

climate, organisms and physico-chemical action of wind, water and sunlight, all

acting over a period of time. Soil differs from the parent materials in the

morphological, physical, chemical and biological properties. Also soil differs among

them in some or all the genetic or environmental factors, therefore, some soils are

yellow, some are black, and some are coarse textured. They serve as a reservoir of

nutrients for plants and crop and also provide mechanical anchorage and favorable

tilth. The land use and land cover map of the study is shown in Figure 3.3. It may be

noted that the land use land cover map reflects predominant agriculture nature of the

impact area, and also its dependence on tanks for irrigation.



The Soil characteristics include both physical and chemical parameters. M/s. Team

Labs and Consultants field team carried out soil survey to assess the soil

characteristics of the study area. Representative soil sampling was done at several

important locations and these locations are shown in Figure 3.4. Analytical data of

soil samples is presented in Table 3.1.



Figure 3.2 Base map of the study area



Figure 3.3 Land use and land cover of the study area (Terms of Reference No. 4(ix) & 5(ii))



Figure 3.4 Soil Sampling Locations



Table 3.1 Soil Analysis Data (Terms of Reference No. 6(viii) Parameter Unit S-1 S-2 S-3 S-4 S-5 S-6 S-7 S-8 S-9 pH - 7.38 7.67 7.92 7.84 7.54 7.42 7.82 7.58 7.95 Electrical Conductivity (EC) dS/m 0.081 0.135 0.176 0.200 0.178 0.172 0.107 0.173 0.298 Bulk Density g/cc 1.11 1.18 1.18 1.18 1.05 1.18 1.25 1.33 1.11 Cation-Exchange Capacity (CEC) Col(+)/kg 1.1 2.7 1.5 1.9 1.6 1.9 1.6 1.7 2.7 Infiltration rate mm/hour 14 14 12 17 13 13 13 18 24 Porosity % 58 56 56 56 60 56 53 50 58 Water Holding Capacity (W.H.C) % 1.03 1.30 1.4 1.9 2.6 0.6 0.51 1.50 1.6 Moisture % 1.04 1.31 1.40 1.91 2.66 0.63 0.51 1.52 1.63 Organic Matter % 1.24 2.75 1.78 0.69 3.64 2.27 1.17 0.89 0.69 Carbonates % Nil Nil Nil Nil Nil Nil Nil Nil Nil Sand % 50 44 36.842 50 45 40 41 44 59 Silt % 31 33 41 33 35 40 39 36 24 Clay % 19 22 22 17 20 20 20 20 17 Organic Carbon % 0.72 1.59 1.04 0.40 2.11 1.31 0.68 0.52 0.40 Nitrogen (as N) % 0.056 0.051 0.067 0.094 0.056 0.077 0.012 0.070 0.171 Carbon / Nitrogen Ration (C/N) - 12.9 31.0 15.5 4.2 37.8 17.1 56.9 7.4 2.3 Phosphorus (as P) % 0.157 0.262 0.236 0.157 0.367 0.210 0.210 0.183 0.262 Potassium (as K) mg/kg 100 212 43 223 99 148 274 157 68 Sodium (as Na) mg/kg 56 95 38 119 43 120 91 119 287 Calcium (as Ca) mg/kg 35 68 101 102 86 101 68 70 70 Magnesium (as Mg) mg/kg 53 165 82 31 84 61 21 53 107 Calcium/Magnesium ratio - 0.66 0.41 1.23 7.29 1.03 1.65 3.29 1.32 0.66 Sodium Absorption Ratio (SAR) - 1.72 1.83 0.80 0.88 0.95 2.68 2.71 3.08 6.27 Chlorides (as Cl) mg/kg 31 60 30 151 61 60 663 123 312 Sulphates (as SO4) mg/kg 1.8 10 4.4 11 7.2 4.2 8.8 10 21 Aluminium (as Al) mg/kg <10 <10 <10 <10 <10 <10 <10 <10 <10 Zinc (as Zn) mg/kg 34 10 22 14 18 14 14 17 14 Texture - Loam Loam Loam Loam Loam Loam Loam Loam Sandy loam

S1-Hazelo Lab Pvt. Ltd., S2-Antammagudem, S3- Dhotigudem, S4-Yellagiri, S5-Lakkaram, S6-Chinna kodur S7-Jublakpalli, S8-Turkaguda andS9-Dharmaji gudem.



The test results of soil samples collected in the impact area are interpreted referring to

the book; “Interpreting soil test results”. The reference tables are presented in Table

3.2. The pH of soil samples ranges from slightly acidic to mildly alkaline. The cation

exchange capacity of the soils is very high (six Samples), contributed mainly by

Sodium exchangeable ions. The level of nitrogen in most of the soil samples is very

low while the potassium levels are low to excessive. The calcium magnesium ratios of

the sample reflect low Calcium in five samples and low magnesium in 1 sample.

Table 3.2 Soil Test Results – Reference Tables

General interpretation of pH measured Rating for Cation exchange Capacity pH Range Classification CEC (Cmol)+)/kg

<4.5 Extremely Acidic Very low <6 * 4.51 -5.0 Very Strong Acidic Low 6-12 5.1-5.5 Strong Acid Moderate 12-25 5.6- 6.0 Moderately Acid High 25-40 6.1-6.5 Slightly acid Very High >40 6.6-7.3 Neutral Source: Metson (1961)

* Soils with CEC less than three are often low in fertility and susceptible to soil acidification.

7.4-7.8 Mildily Alkaline 7.9 -8.4 Moderately Alkaline 8.5-9.0 Strongly Alkaline >9.0 Very Strongly Alkaline

Source: Bruce and Rayment (1982). Ca/mg Ratio Extractable Potassium (K)

Description K <1 Ca Deficient low <150 ppm* (< 0.4 meq/100 g soil) 1-4 Ca (Low) medium 150–250 ppm (0.4–0.6 meq/100 g soil) 4-6 Balanced high 250–800 ppm (0.6–2.0 meq/100 g soil) 6-10 Mg (Low) excessive >800 ppm (>2.0 meq/100 g soil) >10 Mg deficient Source: Eckert (1987) Source: Abbott (1989)

Rating of Total Nitrogen Rating (% by W)

Description

<0.05 Very low 0.05-0.15 Low 0.15-0.25 Modium 0.25-0.50 High >0.5 Very High Source: Bruce and Rayment (1982)



3.3 Water Environment

Industrial development of any region is contingent on the availability of sufficient

water resources, as most of the process industries require water for process or cooling

purposes. The potential for exploitation of ground water resources increases as

development of new projects increases in industrial and agricultural areas. With the

increasing industrialization and urbanization the possibilities of contamination of

surface water and ground water sources are rapidly increasing. The water resources

in the area broadly fall into following categories:

1. Surface Water resources: Streams and ponds, etc.

2. Ground Water resources: Accumulation in deeper strata of ground.

3.3.1 Surface Water Resources

Chinna Musi River is flowing from northwest to northeast direction and passing the

study area at a distance of 5.8 km in northwest direction. There are few surface water

bodies like natural lakes and tanks in the study area. These tanks are located in

southwest and southeast directions of the site. The drainage pattern of the impact

area is dendritic, and the flow in the northern part of impact area is mainly into a

major stream of Chinna Musi River, whereas the southern part is mainly draining into

tanks and flowing towards eastern direction. The digital elevation model map of the

study area is presented in Figure 3.5. It may be noted that the highest point of the

impact area is in the southocwestern part at 450 m above MSL in the forest region due

to hillks, while most of the impact area has MSL ranging from 360 to 380 m above

MSL. The drainage pattern of impact area is presented in Figure 3.6.

3.3.1.1 Surface Water Quality (Terms of Reference No. 6(iv)

The analytical results of water samples drawn from various locations in the study area

during are presented in Table 3.3.



Table 3.3 Water Analysis Data –Suraface Water S.No Parameters Tangallapalli

Cheruvu Units Method of Analysis IS 2296:1982

1 Temperature 31 oC IS:3025 part 09:2002 NS 2 Colour 1 Hazen IS:3025 part 04:2012 300 3 Turbidity <0.1 NTU IS:3025 part 10:2006 NS 4 pH 7.00 - IS:3025 part 11:2006 6.5-8.5 5 Total Solids 386 mg/l IS:3025 part 15:2003 NS 6 Total Dissolved Solids 372 mg/l IS:3025 part 16:2006 1500 7 Total Suspended Solids 14 mg/l IS:3025 part 17:2006 NS 8 Total Hardness (as CaCO3) 210 mg/l IS:3025 part 21:2009 NS 9 Calcium (as Ca) 38 mg/l IS:3025 part 40:2009 NS

10 Magnesium (as Mg) 28 mg/l IS:3025 part 46:2009 NS 11 Sodium (as Na) 56 mg/l IS:3025 part 45:2003 NS 12 Sodium Absorption Ratio

(SAR) 2.0 - - NS

13 Potassium (as K) 11 mg/l IS:3025 part 45:2003 NS 14 Carbonate (as CO3) Nil mg/l IS:3025 part 51:2006 NS 15 Bi carbonate (as HCO3) 185 mg/l IS:3025 part 51:2006 NS 16 Alkalinity (as CaCO3) 185 mg/l IS:3025 part 23:2003 NS 17 Chloride (as Cl) 50 mg/l IS:3025 part 32:2007 600 18 Sulphates (as SO4) 31 mg/l IS:3025 part 24:2009 400 19 Nitrate Nitrogen (as NO3) 53 mg/l IS:3025 part 34:2009 50 20 Silica (as SiO2) 5.6 mg/l IS:3025 part 35:2003 NS 21 Fluoride (as F) 0.20 mg/l IS:3025 part 60:2008 1.5 22 Residual, Free Chlorine <0.2 mg/l IS:3025 part 26:2009 NS 23 Mineral Oil Nil mg/l IS:3025 part 39:2013 NS 24 Cyanide (as CN) <0.02 mg/l IS:3025 part 27:2003 0.05 25 Aluminium (as Al) <0.5 mg/l APHA-3500-Al NS 26 Arsenic (as As) <0.001 mg/l IS:3025 part 37:2003 0.2 27 Boron (as B) <0.1 mg/l IS:3025 part 57:2010 NS 28 Cadmium (as Cd) <0.01 mg/l IS:3025 part 41:2003 0.01 29 Total Chromium (as Cr) <0.02 mg/l IS:3025 part 52:2003 0.05 30 Hexavalent Chromium (as

Cr6+) <0.03 mg/l IS:3025 part 52:2003 0.05

31 Copper (as Cu) <0.01 mg/l IS:3025 part 42:2009 1.5 32 Iron (as Fe) 0.10 mg/l IS:3025 part 53:2009 50 33 Lead (as Pb) <0.01 mg/l IS:3025 part 47:2009 0.1 34 Manganese (as Mn) <0.01 mg/l APHA-3500-Mn NS 35 Mercury (as Hg) <0.01 mg/l IS:3025 part 48:2003 NS 36 Nickel (as Ni) 0.01 mg/l IS:3025 part 54:2003 NS 37 Selenium (as Se) <0.001 mg/l IS:3025 part 56:2003 0.05 38 Zinc (as Zn) <0.005 mg/l IS:3025 part 49:2009 15 42 Oil and Grease <5.0 mg/l IS:3025 part 39:2003 0.1 43 Dissolved Oxygen 4.2 mg/l Is:3025 Part 38:2003 4 44 Chemical Oxygen Demand 13 mg/l IS:3025 Part 58:2006 NS 45 BOD 3 days at 27±10C 4.3 mg/l IS:3025 Part 44:2003 3 46 Total Coliforms 39 MPN

/100 ml APHA9221A&

922B:2012 5000



3.3.2 Ground Water Resources

Ground water is the accumulation of water below the ground surface, caused by

rainfall and its subsequent percolation through pores and crevices. Percolated water

accumulates till it reaches impervious strata consisting of confined clay or confined

rocks. Occurrence of ground water is controlled by land form, structure and

lithology. Ground water abstraction is by means of dug wells, dug cum driven wells,

bore wells and open wells. Ground water resources are ample in the study area.

Every village has a number of bore wells large and small. The state authorities have

also provided tube wells fitted with hand pump for the drinking water requirement of

villages in the study area. Presently the drinking water needs are mostly met from the

ground water resources.

3.3.2.1 Quality of Ground Water (Terms of Reference No. 6(v)

The quality of ground water occurring in the geological formations in the study area is

generally good in most of the areas. The representative samples are collected from

various dug wells and bore wells in the study area. The water samples drawn from

various locations in the study area are presented in Table 3.4. The analytical results of

water samples drawn from various locations in the study area are presented in Table

3.5. The water samples drawn from various locations in the study area are presented

in Figure 3.7.

Table 3.4 Locations of Ground water Sampling S. No Location Name Direction

Form site Distance From Site

(Km) GW-01. Project site -- -- GW -02. Antammagudem W 1.3 GW -03 Dhotigudem N 1.7 GW -04. Yellagiri SW 2.4 GW -05. Lakkaram SE 4.0 GW -06. Chinna Kondur NE 5.5 GW-07. Malkapuram SW 7.2 GW-08. Dharmajigudem SE 3.5



Figure 3.5 Drainage Pattern of the study area (Terms of Reference No. 4(xi))



Figure 3.6 Digital elevation map of the study area



Figure 3.7 Water Sampling Locations



Table 3.5 Water Analysis Data – Ground Water Parameters GW-1 GW-2 GW-3 GW-4 GW-5 GW-6 GW-7 GW-8 GW-9 Units Method of Analysis IS

10500:2012 Standard

Temperature 30 30 30 29 31 34 30 27 28 oC IS:3025 part 09:2002 - Colour 1 1 1 1 1 1 1 1 1 Hazen IS:3025 part 04:2012 5 Turbidity <0.1 <0.1 0.1 0.1 0.1 0.1 <0.1 <0.1 <0.1 NTU IS:3025 part 10:2006 1 pH 7.7 7.32 7.68 7.17 7.38 7.64 7.65 7.72 7.91 - IS:3025 part 11:2006 6.5-8.5 Total Solids 764 867 554 621 683 544 622 675 691 mg/l IS:3025 part 15:2003 NS Total Dissolved Solids 745 851 541 601 666 532 606 664 672 mg/l IS:3025 part 16:2006 500 Total Suspended Solids 19 16 13 20 17 12 16 11 19 mg/l IS:3025 part 17:2006 NS Total Hardness (as CaCO3)

565 694 260 468 442 270 315 543 213 mg/l IS:3025 part 21:2009 200

Calcium (as Ca) 136 166 56 109 55 44 76 121 41 mg/l IS:3025 part 40:2009 75 Magnesium (as Mg) 55 68 29 48 74 39 30 59 27 mg/l IS:3025 part 46:2009 30 Sodium (as Na) 75 67 110 46 93 110 112 72 176 mg/l IS:3025 part 45:2003 NS Sodium Absorption Ratio (SAR)

1.5 1.2 3.4 1.0 2.4 3.5 3.1 1.5 6.1 - - NS

Potassium (as K) 2.6 1.7 11 3.0 0.75 5.7 12 1.9 2.0 mg/l IS:3025 part 45:2003 NS Carbonate (as CO3) Nil Nil Nil Nil Nil Nil Nil Nil Nil mg/l IS:3025 part 51:2006 NS Bi carbonate (as HCO3-) 160 265 180 168 213 183 188 490 110 mg/l IS:3025 part 51:2006 NS Alkalinity (as CaCo3) 160 265 180 168 213 183 188 490 110 mg/l IS:3025 part 23:2003 200 Chloride (as Cl) 268 223 165 121 145 165 165 39 218 mg/l IS:3025 part 32:2007 250 Sulphate (as SO4-) 68 80 29 61 86 22 55 43 94 mg/l IS:3025 part 24:2009 200 Nitrate Nitrogen (as NO3)

35 71 28 101 74 26 33 24 37 mg/l IS:3025 part 34:2009 45

Silica (as SiO2) 9 16 4 11 9 9 9 11 9 mg/l IS:3025 part 35:2003 NS Fluoride (as F-) 0.7 0.6 0.4 0.5 0.6 0.4 0.1 0.8 0.8 mg/l IS:3025 part 60:2008 1.0 Residual, Free Chlorine <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 mg/l IS:3025 part 26:2009 0.20 Mineral Oil Nil Nil Nil Nil Nil Nil Nil Nil Nil mg/l IS:3025 part 39:2013 0.50 Cyanide (as CN) <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 mg/l IS:3025 part 27:2003 0.05 Aluminium (as Al) <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 mg/l APHA-3500-Al 0.03 Boron (as B) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 57:2010 0.50 Cadmium (as Cd) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 41:2003 0.003



Parameters GW-1 GW-2 GW-3 GW-4 GW-5 GW-6 GW-7 GW-8 GW-9 Units Method of Analysis IS 10500:2012 Standard

Total Chromium (as Cr) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 52:2003 0.05 Hexavalent Chromium (as Cr6+)

<0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 mg/l IS:3025 part 52:2003 0.05

Copper (as Cu) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 42:2009 0.05 Iron (as Fe) 0.3 0.4 0.42 0.2 0.40 0.21 0.26 0.23 0.2 mg/l IS:3025 part 53:2009 0.30 Lead (as Pb) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 47:2009 0.01 Manganese (as Mn) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l APHA-3500-Mn 0.10 Zinc (as Zn) <0.5 <0.5 <0.5 0.53 <0.5 <0.5 <0.5 <0.5 <0.5 mg/l IS:3025 part 49:2009 5.0

GW1-Hazelo Lab Pvt. Ltd. site, GW2-Antammagudem, GW3-Dothigudem, GW4-Yellagiri, GW5-Lakkaram, GW6-Chinna kodur, GW7-Jublakpalli, GW8-Turkaguda and GW9-Dharmaji gudem.

Note: All values are expressed in mg/l except pH.



3.4 Air Environment

3.4.1 Meteorology

Micro meteorological studies are simultaneously conducted with the air quality

monitoring. Meteorology plays a vital role in effecting the dispersion of pollutants,

once discharged into the atmosphere, their transport, dispersion and diffusion into the

environment. The meteorological data is very useful for interpretation of the baseline

information and for model study of air quality impacts also. Since meteorological data

show wide fluctuations with time, meaningful interpretation can only be drawn from

long term and reliable data. Such source of data is the Indian Meteorological

Department (IMD), which maintains a network of meteorological stations at several

important locations. The normal climatological data provided by IMD, summarizing

the data recorded during 1981 - 2010 is presented in Table 3.6.



Table 3.6 Meteorological data at IMD Station



3.4.2 Meteorological Station at Plant Site (Terms of Reference No. 6(i))

The micro meteorological data at the industry site is collected simultaneously with

ambient air quality monitoring. The station was installed at height of 10 meters above

the ground level and the same is located in such a way that there are no obstructions

facilitating free flow of wind. Wind speed, wind direction, humidity and temperature

are recorded on hourly basis in the study area. Salient features of micro

meteorological data collected are as follows:

1. Wind Direction and Speed:

The hourly wind speed and wind direction observations are computed during study

period of winter season and the same are presented in Table 3.7 and the wind rose

diagram is presented in Figure 3.8. The following observations can be made from the

collected data;

• Calm period is observed to be 16.62 % during the time of monitoring.

• The predominant wind direction is east.

• Other than predominant wind directions wind was blowing in eastsoutheast and

southeast.

• Mostly the wind speeds are observed to be in the range of 5-10 kmph and 10-15

kmph.

2. Temperature: It may be noted that the daily temperature variations were:

maximum temperature 36.4 ºC and minimum temperature 14.2 ºC.

3. Humidity: The daily relative humidity values are observed to range between 35 to

65%.

4. Rain Fall: (a) Maximum: 12 mm (b) Minimum: 0 mm



Table 3.7 Frequency Distribution of Wind Speeds and Wind Directions

Direction Wind Speed (KMPH) Total Calm 1-5 5-10 10-15 >15 N 4.35 0.79 5.14 NNE 4.12 1.20 5.32 NE 3.15 0.74 3.89 ENE 3.33 1.44 0.32 5.09 E 9.26 13.52 1.85 0.05 24.68 ESE 5.42 6.44 1.06 12.92 SE 5.65 3.43 0.56 9.63 SSE 1.11 0.32 1.44 S 1.02 1.02 SSW 0.42 0.09 0.51 SW 0.60 0.23 0.83 WSW 0.51 0.32 0.83 W 2.69 1.02 3.70 WNW 2.36 0.46 2.82 NW 2.55 0.05 2.59 NNW 2.92 0.05 2.96 Calm 16.62 16.62 Total 16.62 49.44 30.09 3.80 0.05 100.00

Monitoring Period: December 2016 - February 2017



WRPLOT View - Lakes Environmental Software

WIND ROSE PLOT:

COMMENTS: COMPANY NAME:

M/s.Hazelo Lab Pvt.Ltd.,

MODELER:

M/s.Team Labs and Consultants, Hyderabad.

PROJECT NO.:

NORTH

SOUTH

WEST EAST

6%

12%

18%

24%

30%

WIND SPEED (m/s)

>= 4.2

2.8 - 4.2

1.4 - 2.8

0.3 - 1.4

Calms: 16.62%

TOTAL COUNT:

2160 hrs.

CALM WINDS:

16.62%

DATA PERIOD:

Start Date: 12/1/2016 - 00:00End Date: 2/28/2017 - 23:00

AVG. WIND SPEED:

1.06 m/s

DISPLAY:

Wind SpeedDirection (blowing from)

Figure 3.8 Wind Rose Diagram at Site



3.4.3 Ambient Air Quality

Air pollution means the presence in the outdoor atmosphere of one or more

contaminants or combinations thereof in such quantities and of such duration as are

or may tend to be injurious to human, plant or animal life or property. Air pollutants

include smoke, vapors, soot, fumes, gases, mist, odors, particulate matter, radioactive

material or noxious chemicals. The proposed industrial activity may generate a range

of different pollutants which are released into the atmosphere. These pollutants

disperse in the air shed contingent on the meteorology and may have a significant

impact on neighborhood air environment and air quality. Thus collection of base line

data of air environment occupies a predominant role in the impact assessment

statement. The ambient air quality status across the study zone forms basis for

prediction of the impacts due to the project. The data required for assessing air

quality impacts in and around neighborhood is achieved by designing such a

network, which encompasses micro meteorological conditions, quantity and quality of

emissions, locations, duration, resources/monitoring technology and operational

criteria. The optimal scheme for air quality monitoring should consider all the above

factors.

3.4.4 Scope of Field Study

The scope of baseline status of the ambient air quality can be assessed through a well-

designed ambient air quality stations network. An intensive ambient air quality

monitoring of the study area consisting of 10 km radius with the industry site as the

center point was carried out during the period. The ambient air quality was

monitored at eight locations in the study area. Figure 3.9 presents the locations of

ambient air quality monitoring stations. At each sampling station monitoring was

carried out for 24 hours in a day for 2 days a week, and for eight months. The air

pollutants monitored on 24 hourly basis are, Particulate Matter (Size Less than 10µm)

or PM10 µg/m3, Particulate Matter (Size Less than 2.5µm) or PM2.5 µg/m3, Sulfur

dioxide and Oxides of Nitrogen. Sampling and analysis of the above variables is

according to the guidelines of Central Pollution Control Board. The National Ambient

Air quality standards are presented in Table 3.8.



Table 3.8 National Ambient Air Quality Standards

Pollutant Time

Weighted Average

Concentration in Ambient Air

IRR ESA Methods of Measurement

Sulphur Dioxide (SO2), µg/m3

Annual* 24 Hours**

50 80

20 80

- Improved west and Gaeke - Ultraviolet fluorescence

Nitrogen Dioxide (NO2), µg/m3

Annual* 24 Hours**

40

80

30

80

- Modified Jacob & Hochheiser (Nn-Arsenite)

- Chemiluminescence Particulate Matter (Size Less than 10 µm) or PM10 µg/m3

Annual* 24 Hours**

60 100

60 100

- Gravimetic - TOEM - Beta Attenuation

Particulate Matter (Size Less than 2.5µm) or PM2.5 µg/m3

Annual* 24 Hours**

40

60

40

60

- Gravimetic - TOEM - Beta Attenuation

Ozone (O3) µg/m3 8 hours** 1 hour**

100

180

100

180

- UV Photometric - Chemilminescence - Chemical Method

Lead (Pb) µg/m3 Annual* 24 hours**

0.50

1.0

0.50

1.0

- AAS method after sampling on EPM 2000 or equivalent filter paper

- ED-XRF using Teflon filter Carbon Monoxide (CO) ng/m3

8 hours** 1 hour**

02

04

02

04

- Non Dispersive Infra Red (NDIR)

- Spectroscopy Ammonia (NH3) µg/m3

Annual* 24 hours**

100 400

100 400

- Chemilminescence - Indophenol blue method

Benzene (C6H6) µg/m3 Annual* 05 05

- Gas Chromotography based continuous analyzer

- Absorption and Desorption followed by GC analysis

Benzo(o)Pyrene(BaP)–Particulate Phase only, ng/m3

Annual* 01 01 - Solvent extraction followed by GC analysis

Arsenic (As), ng/m3 Annual* 06 06 - AAS method after sampling on EPM 2000 or equivalent filter paper

Nickel (Ni), ng/m3 Annual* 20 20

IRR-Industrial, Residential, Rural and Other Area, ESA- Ecological Sensitive Area G.S.No.826 (E) dated 16th November, 2009. Vide letter no. F. No. Q-15017/43/2007-CPW.s *Average Arithmetic mean of minimum 104 measurements in a year taken for a week 24 hourly at uniform interval. **24 hourly/8 hourly values should meet 98 percent of the time in a year.



3.4.5 Description of Sampling Locations

The location of ambient air quality stations is contingent on the meteorological status

of the area. Hence the micro meteorological data was collected before initiating the

ambient air quality monitoring. Table 3.9 presents the ambient air quality locations

and their distances and directions from the plant site.

Table 3.9 Locations of Ambient Air Quality Monitoring Stations

S.No Location Direction Distance from Plant site (Km)

A-1 Plant site - - A-2 Antammagudem W 1.3 A-3 Dhotigudem N 1.7 A-4 Yellagiri SW 2.4 A-5 Lakkaram SE 4.0 A-6 Chinna Kondur NE 5.5 A-7 Jalalapur NW 7.0 A-8 Koyalgudem SE 3.4




Figure 3.9 Ambient Air Quality Monitoring Locations



3.4.6 Ambient Air Quality Status (Terms of Reference No. 6(ii), (iii) & Sp. TOR (3))

The existing baseline levels with respect to Particulate Matter (Size Less than 10µm) or

PM10 µg/m3, Particulate Matter (Size Less than 2.5 µg/m3) or PM2.5 µg/m3, Sulphur

dioxide and oxides of nitrogen at 8 locations are presented in Table 3.10. The

parameters monitored at the site show the following variations; the voc and HC

values are observed below detectable limits, the other parameters of NAAQ standards

are found to be below detectable limits except for PM10, PM2.5, SO2 and NOx. It may

be observed that the all parameters at all stations are well within the limits prescribed

by Central Pollution Control Board.

Table 3.10 Summary Ambient Air Quality Status Pollutant Maximum Minimum Mean 98 Percentile

AAQ-1) Location: Site PM10 50 39 44.5 49 PM2.5 18 14 16.26 18 SO2 12 9 10.23 12 NOx 14 9 12.31 14 VOC in PPM 2.5 0.3 1.5 2.2 CO in PPM 0.6 0.1 0.5 0.5 AAQ-2) Location: Antammagudem PM10 44 36 40.0 43 PM2.5 17 14 14.15 17 SO2 11 9 10.23 11 NOx 13 9 10.35 13 VOC in PPM 0.6 0.3 0.4 0.5 CO in PPM 0.3 0.1 0.2 0.3 AAQ-3) Location: Dhotigudem PM10 43 32 37.5 42 PM2.5 18 13 13.02 18 SO2 11 9 9.85 11 NOx 13 9 12.16 13 VOC in PPM BDL BDL BDL BDL CO in PPM 0.2 0.0 0.1 0.1 AAQ-4) Location: Yellagiri PM10 42 35 38.5 41 PM2.5 16 13 14.25 16 SO2 10 9 9.24 9 NOx 13 9 12.15 13 VOC in PPM BDL BDL BDL BDL CO in PPM 0.3 0.1 0.2 0.3 AAQ-5) Location: Lakkaram PM10 40 25 32.5 39 PM2.5 16 13 14.85 16 SO2 10 9 9.47 10 NOx 11 9 9.74 11 VOC in PPM BDL BDL BDL BDL CO in PPM 0.3 0.1 0.2 0.3



AAQ-6) Location: Chinna Kondur PM10 44 33 38.5 43 PM2.5 17 13 14.25 17 SO2 11 9 9.35 11 NOx 13 9 11.95 13 VOC in PPM BDL BDL BDL BDL CO in PPM 0.3 0.1 0.2 0.3 AAQ-7) Location: Jalalpur PM10 39 27 33.0 38 PM2.5 18 13 14.32 18 SO2 11 9 9.49 11 NOx 12 9 10.26 12 VOC in PPM BDL BDL BDL BDL CO in PPM 0.3 0.1 0.2 0.3 AAQ-8) Location: Koyalgudem PM10 47 35 41.0 46 PM2.5 16 13 14.34 17 SO2 11 9 9.38 11 NOx 13 9 11.0 13 VOC in PPM BDL BDL BDL BDL CO in PPM 0.3 0.1 0.2 0.3

Note: Pollutant concentrations are presented in µg/m³ VOC concentration measured as Isobutylene euivalent

3.5 Noise Environment (Terms of Reference No. 6(vii)

Noise is an unwanted sound without musical quality. Artificial noise and its impact

on environment, grown apace with advancing human civilization. Noise pollution is

equally hazardous to environment as air, water and other forms of pollution. Various

noise measurement units have been introduced to describe, in a single number, the

response of an average human to a complex sound made up of various frequencies at

different loudness levels. The most common scale is, weighted decibel dB (A), and

measured as the relative intensity level of one sound with respect to another sound

(reference sound).

The impact of noise depends on its characteristics (instantaneous, intermittent or

continuous in nature), time of day (day or night) and location of noise source. Table

3.11 shows the effects of different noise levels on human beings. The environmental

impact of noise can have several effects varying from noise induced hearing loss to

annoyance depending on noise levels.

The assessment of noise pollution on neighborhood environment due to industry was

carried out keeping in view, all the considerations mentioned above. The existing



status of noise levels is measured at eight locations at various villages within the

study area. Figure 3.10 presents noise level monitoring locations. The monitored

noise levels are shown in Table 3.12. Noise levels are observed to be with in the

prescribed limits of rural and residential areas. Noise levels are high at the traffic

junctions compared to the industrial and village areas. The highest noise levels are

observed at plant site i.e., 64 dB (A) during day time and extremely low at

Koyalgudem i.e., 36 dB (A) during night time in the study area at the time of

measurement.

Table 3.11 Effects on Human Beings at Different Noise Levels Source Noise Level

dB(A) Effects

Large Rocket Engine (near by) 180 Threshold of Pains Hydraulic Press ( 1 m ) 130 Jet take off (60 m) 120 Maximum vocal effort possible Automobile Horn (1m) 120 Construction Noise (3m) 110 Jet Take off (600 m) 110 Shout, Punch, Press, Circular Saw 100 Very annoying Heavy Truck (15m), Farm Machinery

90 Prolonged exposure Endangers Lathes, Sports Car, Noisy Machines hearing loss

Automobile (15m) 80 Annoying Freeway Traffic (15m) 70 Telephone is difficult, intrusive Loud Conversations 60 Living Room in Home 50 Quiet Power Station (15m) 50 Bed Room in Home 40 Soft Whisper (5m) 30 Very quiet Tick of Wall clock (1m) 30 Low radio Reception 20 Whisper 20 Rattling of Leaves by Breeze 10 Barely audible 0 Threshold of hearing

Table 3.12 Equivalent Noise levels in the Study Area S.No. Location Equivalent Noise Levels dB(A)

Leq day Leq night 1. Plant site 64 51 2. Antammagudem 51 40 3. Dhotigudem 48 39 4. Yellagiri 49 37 5. Lakkaram 50 38 6. Chinna Kondur 52 39 7. Jalalapur 52 39 8. Koyalgudem 49 36




Figure 3.10 Noise Sampling Locations



3.6 Socio Economic Environment (Terms of Reference No. 6(xi)

Industrial development reflects in social development, i.e., growth in infrastructure

facilities, growth in employment rates, increased demands for housing, and other

amenities etc., which will have a bearing on the socio economic status.

Socio-economic survey is conducted to ascertain the existing socio-economic status to

compare the same with the developments due to the project. Baseline data of

demographic characteristics- occupational status, literacy, health status and the access

to infrastructure facilities for social development in the project area has been studied

from the secondary data collected from census department by M/s. Team Labs and

Consultants.

Demographic characteristics of the study area falling within 10 km radius of the

project site have been compiled to assess the pre-project socio-economic status.

Secondary data has been collected from various government agencies i.e., chief

planning officer, Yadadri Bhuvanagiri district and other government departments of

forestry, irrigation etc., and Mandal Development Offices of the relevant government

departments. Census 2011 was complied and presented as follows.

3.6.1 Demography

The study area falls under the following mandals of Yadadri Bhuvanagiri (previously

part of Nalgonda district) district; Pochampalle, and Choutuppal. Study area

comprises of 27 revenue villages and 10 hamlets.

3.6.1.1 Population Distribution

The population distribution of the study area is presented in Table 3.13. The

population density in the study area is less reflecting the rural nature and lack of

irrigation facilities. The total population of the area is 154932 consisting of 79634

males and 75298 females. The population of the scheduled castes is 27966 consists of

14181 males and 13785 females, while the scheduled tribe population is 3077 consists

of 1564 males and 1513 females, which is 18.05% and 1.9 % of the total population

respectively.



Table 3.13 Population Distribution – Study Area Category kms Total

0-3 3-5 5-7 7-10 Total Population 1796 8934 73535 70667 154932 Total Population – Male 936 4622 37572 36504 79634 Total Population – Female 860 4312 35963 34163 75298 Population <6 years 224 1118 8033 7905 17280 Male <6 years 112 601 4113 4147 8973 Females < 6years 112 517 3920 3758 8307 Scheduled Caste Population - Total 229 1670 13292 12775 27966 Male – SC 116 852 6713 6500 14181 Female – SC 113 818 6579 6275 13785 Scheduled Tribe Population Total 3 65 971 2038 3077 Male – ST 1 27 511 1025 1564 Female – ST 2 38 460 1013 1513

3.6.1.2 Literacy

Census operations consider a literate as a person who is above six years old and who

can write and read as per the census. Table 3.14 presents the literacy levels in the

study area. The population below six years old is 17280 consists of 8973 males and

8307 females, which is 11.15 % of the study area population. It may be observed that

the literacy levels among females in general are low compared to the literacy levels

among males. The percentage of literacy level in the study area among males is

75.87% and 53.64% among females. It may be observed that the literacy level among

females is comparatively less than males.

Table 3.14 Literacy Study Area Category kms Total

0-3 3-5 5-7 7-10 Total Population 1796 8934 73535 70667 154932 Total Population – Male 936 4622 37572 36504 79634 Total Population – Female 860 4312 35963 34163 75298 Population <6 years 224 1118 8033 7905 17280 Male <6 years 112 601 4113 4147 8973 Females < 6years 112 517 3920 3758 8307 Total Literates 955 5073 42937 40578 89543 Male –Literates 594 3058 25556 24400 53608 Female – Literates 361 2015 17381 16178 35935 Total Illiterates 841 3861 30598 30089 65389 Male –Illiterate 342 1564 12016 12104 26026 Female – Illiterate 499 2297 18582 17985 39363



3.6.1.3 Employment/Occupation

Work is defined as participation in any economically productive activity - Physical/

mental. The work force is classified into three categories: a) main workers, b) marginal

workers and c) non-workers. Main workers are those who work for a substantial part

of the year for a living such as salaried employees, agricultural labor etc. Marginal

workers are those who worked the previous year but have not worked for a

substantial part of this year. Non-workers constitute students, housewives,

dependents, pensioners etc. Table 3.15 presents the population distribution for

employment.

It may be observed that a majority of the study area population falls in the non-

worker category among 52.25 % of the population and the marginal workers form

about 6.87% of the total population. The male female difference is also significant in

all the regions and in all the categories. There are few females among the workers

where as there are more non-workers and marginal workers among females.

Table 3.15 Employments - Study Area Category kms Total

0-3 3-5 5-7 7-10 Total Population 1796 8934 73535 70667 154932 Total Population – Male 936 4622 37572 36504 79634 Total Population – Female 860 4312 35963 34163 75298 Total Workers 889 4404 34583 34105 73981 Total Workers – Male 503 2613 20750 20205 44071 Total Workers – Female 386 1791 13833 13900 29910 Total Main Workers 532 3829 30496 28475 63332 Main workers – Male 349 2439 19723 18656 41167 Main Workers – Female 183 1390 10773 9819 22165 Total Marginal Workers 357 575 4087 5630 10649 Marginal Workers – Male 154 174 1027 1549 2904 Marginal Workers – Female 203 401 3060 4081 7745 Total Non Workers 907 4530 38952 36562 80951 Non Workers – Male 433 2009 16822 16299 35563 Non Workers – Female 474 2521 22130 20263 45388

The main workers are further classified into; Total cultivators: those who engage a

single worker or his family member to cultivate land for payment in money, kind or

share; Agricultural labor: those who work in other’s lands for wages; Livestock,

forestry, fishing and allied activities; Workers involved in mining and quarrying;



Workers involved in manufacturing and processing industries in the house hold

industries; non house hold industries; construction workers; workers in trade and

commerce; workers involved in transport, storage and communication ; and other

services: government employees, teachers, priests, artists etc. Table 3.16 presents the

main workers distribution among the study area population.

Table 3.16 Main Workers - Study Area Category Kms Total

0-3 3-5 5-7 7-10 Total Population 1796 8934 73535 70667 154932 Total Population – Male 936 4622 37572 36504 79634 Total Population – Female 860 4312 35963 34163 75298 Total Main Workers 532 3829 30496 28475 63332 Main workers – Male 349 2439 19723 18656 41167 Main Workers – Female 183 1390 10773 9819 22165 Total Cultivators 168 755 5526 5556 12005 Cultivators – Male 113 506 3655 4048 8322 Cultivators- Female 55 249 1871 1508 3683 Total Agriculture Labor 152 1344 8069 10116 19681 Agriculture Labor – Male 50 575 2934 4173 7732 Agriculture Labor – Female 102 769 5135 5943 11949 Total Household Workers 13 99 2406 918 3436 Household Workers – Male 11 50 1534 623 2218 Household Workers – Female 2 49 872 295 1218 Total Others 199 1631 14495 11885 28210 Others – Male 175 1308 11600 9812 22895 Others – Female 24 323 2895 2073 5315

It may be observed that over 12.7 % of the study area population is involved in

cultivation or agriculture labor, followed by other services to the tune of 18.21% which

is largely due to the proximity to Hyderabad town. Significant differences are

observed among the male and female workers, Female workers are found to be more

in agricultural activity largely due to more percentage of females being agricultural

labor.

3.6.2 Living Standards and Infrastructure

Sustainable development of any area is dependent not only the population but also on

the availability of infrastructure which leads to better living standards. The

infrastructure facilities are essential in providing education, awareness, health,

communication, potable water, transport etc. The standard of living is the sum of the



availability of the infrastructure to the subject community, wide variations in terms of

income, economic conditions and patterns of spending.

The infrastructure facilities available in the impact zone are reflecting the rural nature

of the entire study area.

I. Educational Facilities

The educational facilities available in the rural areas are meager, despite the proximity

to urban area of Hyderabad. There are 46 primary schools, 19 middle schools and 14

high schools in the study area. There is one junior college in the area. Four of the

villages in the study area do not have any educational facilities. The higher

educational need of the population is met by choutuppal.

II. Health facilities

The medical and health facilities available in the impact zone are inadequate; there is

no PHC, 11 PHS and no Child welfare centers and RP centers in the entire area. The

health needs of the population in this area are met by quacks and other semi qualified

persons.

III. Availability of Potable Water

The entire population in this area is dependent on ground water for drinking

purposes. About 14 villages in the study area are dependent on tube wells, while the

remaining villages are dependent on wells and hand pumps.

IV. Transport and Communication

Transport is essentially provided by the Telangana State Road Transport Corporation

(TSRTC). Most of the study area has excellent road network in all the villages except

in one village, which has kacha roads. TSRTC bus facility is available for the all the

villages. However it is observed that a number of private transport vehicles are

observed in the area connecting them to choutuppal.

V. Sources of Energy and Availability

The primary source of energy in the study area is electricity, and the entire study area

has electricity for agriculture and domestic purpose. The urban areas have LPG

facility for their cooking purpose. A significant number of people in the urban area



are also dependent on Kerosene for cooking purposes, which is contingent on the

vagaries of public distribution system. A majority of the rural area is mostly

dependent on Kerosene, dried cow dung cakes, wood from roadside trees for their

domestic energy needs.

VI. Post and Telegraph facilities

There are 27 post offices in the area and 27 post & Telegraph office in the study area.

Phone facilities however are extended to some of the villages.

VII. Housing

Census defines the house hold as a group of persons living together and sharing their

meals from a common kitchen. The number of households in the impact zone is

15181. The density of the households is approximately six. The traditional houses

made up of mud walls and covered by dry common grass and leaves of bourses are

commonly found in the rural area, which are not considered pucca houses. The

government has been augmenting the housing standards by constructing housing

colonies for various weaker sections of the society.

3.6.3 Land Utilization

Land use patterns can be prepared on the basis of revenue records though it is not an

exact indicator of the actual use of the land at a given time. Land use is presented

under the heads of area under forest cover irrigated land, area under cultivation and

cultivable wasteland in Table 3.17.

Table 3.17 Land Utilization Pattern Category kms Total Area,

Ha 0-3 3-5 5-7 7-10 Land Under Miscellaneous Tree Crops etc. - 29 173 131 333 Forest 0 186 869 274 1329 Area under Non-Agricultural Uses 24 149 523 621 1317 Culturable Waste Land 75 248 1562 776 2661 Area Irrigated by Source 87 377 1255 2699 4418 Barren & Un-cultivable Land 103 322 2589 1544 4558 Unirrigated Land 344 2776 5660 7063 15843

Total 633 4087 12631 13108 30459

It may be observed that a majority of the study area is Unirrigated, followed by

Barren & Un-cultivable Land.



3.6.4 Project Economy

M/s. Hazelo Lab Pvt.Ltd., proposes to expand the manufacturing capacity from 10.5

TPM to 495 TPM by acquiring additional land area of 29.16 acres, total land area after

expansion is 33.485 acres.

There is a potential for direct/indirect employment of about 60 people during

construction phase and 100 during operation phase. It will be spending approximately

35 Lakhs of rupees every month on salaries providing bread and succor to 100

families additionally. The proposed project will also generate indirect employment to

the locals during construction phase. The employers will contribute to the provident

fund, ESI and provide facilities as per the relevant labor act.

The proximity of Choutuppal town will provide access to the extensive medical

facilities available apart from the ESI medical facilities to the employees and their

families. An industrial Canteen is established by the company.

It may be concluded that satisfactory amenities are available for the population of the

impact zone, while the amenities are available either within the village or at a

minimum distance of 1 km. The area also has large tracts of waste lands which can

be utilized for industrial development.

3.7 Flora and Fauna (Terms of Reference No. 6(x)

In order to assess the baseline status of the flora of the study area, field surveys were

undertaken during the winter season of 2016 - 2017. Primary data on flora was

collected from extensive field surveys during the study period. As far as the fauna is

concerned, both primary and secondary were used and validated basing on published

reports of the ZSI, Forest department and research papers.

3.7.1 Land use and land cover of the study area

The land acquired for the chemical plant is a rocky wasteland with scattered, stunted,

nonpalatable bushes. It is more or less a plain land with a gentle slope from south to

north. Vegetation, flora and fauna of the project site and its surroundings up to a

radius of 10 Km were studied during the winter season of 2016. A survey of the flora

and fauna of the project site and its environs up to a radius of 10 Km reveals the

absence of thick forests but open scrub type communities were very common. There



are no sanctuaries or national parks or biosphere reserves or any other protected or

ecologically sensitive areas within a radius of 10 Km from the plant site.

3.7.2 Land use and land cover of the plant site

There are no trees and it was not put to any productive use earlier. There are no

ponds or water bodies or any constructions within the area. The area is sparsely

colonized by Cassia auriculata, Alhagi camelorum, Carissa spinarum, Lantana camara,

Propsopis juliflora, Mimosa rubicaulis, Alangium salvifolium, Acacia leucophloea, Calotropis

procera, Calotropis gigantea, Maytenus emerginata, Canthium dicodccum, Benkara

malabarica, Catunaegam spinosa, Morinda pubescens, Vitex negundo, Waltheria indica,

Tephrosia purpurea, Breynia vitis-ideae, Phyllanthus reticulatus, Acacia cesia, etc. Apart

from these perennials, a few palatable grasses and nonpalatable weeds were also

present. Within the site a few isolated individuals of both palatable and non palatable

weeds represented by Hyptis suaveolens, Parthenium hysterophorus, Celosia argentia,

Sida acuta, Cassia occidentalis, Cassia tora, Cleome viscosa, Heliotropium indicum, Croton

bonplandianum, Amaranthus spinosus and Cassia occidentalis. Cymbopogon coloratus,

Heteropogon contortus, Erempogon foeveolatus, Dicanthium annulatus, Digera arvensis,

Chloris barbata, Dactyloctenium aegyptium, Iseilema laxum, Andrographis echinoids etc were

found in association with the perennials. But none of them belong to the rare or

endangered or endemic or threatened (REET) category.

3.7.3 Terrestrial Vegetation and Flora in the study area

The following open dry deciduous scrub forests were found within the 10Km

i). Lakkaram reserve forest towards South at a distance of 1.2 km, ii). Chauttuppal

reserve forest towards Northwest at a distance of 4.8 km, iii). Malkapuram reserve

forest towards west at a distance of 2.2 km, iv). Hafeezpura reserve forest towards

southwest at a distance of 7.0 km, v). Ailaupur reserve forest towards southwest at a

distance of 6.7 km, vi). Meharnagar reserve forest towards northwest at a distance of

5.3 km and vii). Jalalpur reserve forest towards northwest at a distance of 6.7 km.

Tall Palmyrah Palms (Borassus flabellifer) and Date Palms (Phoenix sylvestris) palm are

scattered in the wastelands and along the flield bunds. Prosopis juliflora was indeed

the most widespread and abundant wasteland species. Cassia auriculata was the most



common associate of Prosopis juliflora in large areas especially in wastelands. Sweet

lime, Sour lime, Sapota, Amla, Custard Apple and Guava are also cultivated. There

were no forests but few forest elements were found here and there. The tree flora of

the study area was represented by the common avenue, shade, fruit and ornamental

trees as listed in Table 3.18. There was nothing exceptional about the flora of the

study area. Thick ground vegetation represented by grasses and forbs could be found

on account of good monsoon.

Table 3.18 List of tree species found in the study area Latin name Vernacular name occurrence Acacia nilotica Nalla tumma Widespread Acacia auriculiformis Auriculiformis As avenue tree and in pure

plantations Acacia caesia Kirintha Common Wild shrub Acacia leucophloea Tella tumma Widespread in wastelands Acacia sundra Sundra Widespread in wastelands Aegle marmelos Maredu Wild and also cultivated Ailanthus excelsa Peddamaanu Avenue tree Albizia lebbek Dirisanam Avenue tree Alhagi camelorum Camel thorn Wild shrubs Annona squamosa Custard apple Very common fruit tree Azadirachta indica Vepa Avenue tree Bauhinia racemosa Ari Avenue tree Bauhinia variagata Mandari Avenue tree Benkara malabarica Pedda manga Common thorny shrub Bombax ceiba Booruga Avenue tree Borassus flabellifer Taati / Taadi Extensive and abundant palm Breynia retusa Chinna purugudu Common Wild shrub Breynia vitis-ideae, Nalla purugudu Common Wild shrub Butea monosperma Modugu Forests and in plains Canthium dicoccum Nalla balusu Sporadic thorny bush Canthium parviflorum Balusu Common thorny bush with edible

fruits Cassia fistula Rela Avenue tree Casuarina equisetifolia Sarvi (Sarugudu) Agro-forest species Catunaregam spinosa Manga / Chinna

manga Occasional thorny bush

Chloroxylon sweitenia Billudu Remnant of forest species. Cocos nucifera Coconut Cultivated. Dalbergia sisso Sisso or seesum Widely grown Desmodium pulchellum Deyyapu mokka Common Wild shrub Diospyros melanoxylon Tunki Occasional Eucalyptus spp. Jama oil Agro forest species. Euphorbia caducifolia Brahma jemudu In dry rocky areas Feronia elephantum Velaga Limited Ficus benghalensis Marri Avenue tree



Latin name Vernacular name occurrence Ficus religiosa Raavi Avenue tree Hardwickia binata Yepi Remnants of forest. Holoptelia integrifolia Nemali naara Common avenue tree Lagerstroemia parviflora Chennangi Avenue tree Leucaena leucocephala Subabul In plantations Mangifera indica Mamidi Occasionally cultivated Mimosops elengi Pogada Avenue tree Moringa olivaefera Munaga Cultivated. Muntingia calabura Wild cherry Avenue tree Phoenix sylvestris Eetha Widespread Phyllanthus emblica Usiri Cultivated Phyllanthus eticulates Pulasari / Puliseru Common Wild shrub Phoenix sylvestris Eetha Common along drains Pithecellobium dulce Seema chinta Avenue and hedge plant Polyalthia longifolia Ashoka Avenue tree Polyalthia pendula Asoka Avenue tree Pongamia pinnata Ganuga Extensively grown. Prosopis juliflora English tumma Extensive and abundant Prosopis spicigera Jammi chettu In dry areas. Samanea saman Nidrabhangi Avenue tree Sapindus emarginatus Kunkundu Extensively grown. Spathodea companulata Flame of the forest Avenue tree Sterculia foetida Adavi badam Avenue tree Syzigium cumini Neradu Extensively grown. Tamarindus indica Chinta Extensively grown. Tectona grandis Teku Extensively grown. Terminalia arjuna Tella maddi Avenue tree Thespecia populnea Ganga Raavi Avenue tree Vitex negundo Vaavili Wild road side bush Ziziphus numularia Gotti Common degraded forests Ziziphus rugosus Regu Wild and also cultivated

Prosopis juliflora appears to be the most extensive, widespread and dominant plant in

all vacant lands including roadsides. Cassia auriculata was quite conspicuous in the

open places within the Prosopis juliflora formation. Other prominent tree species

include Neem (Azadirachta indica), Tamarind (Tamarindus indica), Holoptelia integrifolia,

Ailanthus excelsa, Pongamia pinnata, Vitex negundo, Alhagi camelorum, Lantana camara,

Carissa spinarum, Ziziphus numularia, Calotropis procera, Calotropis gigantea, Waltheria

indica, Tephrosia purpurea, Breynia vitis-ideae, Phyllanthus reticulatus, Acacia caesia,

Desmodium pulchellum, Acacia chundra, Acacia leucophloea, Acacia nilotica and Diospyros

melanoxylon. The herbaceous flora was dominated by Senna uniflora, Tridax

procumbens, Cressa cretica, Hyptis suaveolens, Parthenium hysterophorus, Celosia argentia,

Sida acuta, Cassia occidentalis, Cassia tora, Cleome viscosa, Heliotropium indicum, Croton



bonplandianum, Amaranthus spinosus, Cassia occidentalis, Cymbopogon coloratus,

Heteropogon contortus, Erempogon foeveolatus, Dicanthium annulatus, Digera arvensis,

Cressa critica, Chloris barbata, Dactyloctenium aegyptium, Iseilema laxum, Andrographis

echinoids etc were the other common widely scattered herbaceous species. Cotton,

Paddy, Jowar and Red gram were the most widely cultivated crops in upland areas

without assured irrigation. Maize, Bajra, Tomato, Chillies, Castor etc were grown

occasionally. There were also orchards of Amla (Phyllanthus emblica) Sweet lime,

sapota, Guava and Custard apple. All the trees present in and around the site are the

common avenue trees which are present through out the State of Telangana as well as

in other Southern States. There were no Rare or endemic or endangered or threatened

(REET) species. None of the plant species listed in Red Data was found in the study

area. A list of trees and shrubs found in the study area of project site is given in

Table 3.19. Most of the trees, herbs and shrubs found in the study area were

common to many inland areas of Telangana. In addition to the above, several

herbaceous weeds were also found in association with crops and orchards.

Table 3.19 Comparative list of the Weed flora in the study area + indicates presence and – indicates absence

Name of the weed Family Plant site Buffer area Abutilon crispum Malvaceae - + Abutilon indicum Malvaceae - + Acalypha lanceolata Euphorbiaceae - + Acanthospermum hispidum Asteraceae + + Achyranthes aspera Amaranthaceae + + Aerva lanata Amaranthaceae + + Ageratum conyzoides Asteraceae + + Allmania longipdunculata Amaranthaceae + + Allmania nodiflora Amaranthaceae + + Alloteropsis cimicina Poaceae + + Alternanthera sessilis Amranthaceae + + Alternanthra pungens Amaranthaceae - + Althaea rosea Malvaceae - + Alysicarpus monilifer Fabaceae + + Amaranthus spinosus Amaranthaceae + + Amaranthus viridis Amaranthaceae + + Amaranthus roxburghianus (Amaranthus polygamus)

Amaranthaceae - +

Amiscophacelus axillaries (Cyanoits axillare)

Commelinaceae + +

Ammania baccifera Lythraceae - + Argemone mexicana Papavaraceae - + Aristolochia bracteolata Aristolochiaceae - +



Name of the weed Family Plant site Buffer area Bacopa monnieri Srophulariaceae - + Bergia capensis Elantinaceae - + Biophytum nervifolium (=B.sensitivum)

Oxalidaceae - +

Bothriochloa pertusa Poaceae + + Brachiaria reptans Poaceae + + Brachiaria romosa Poaceae + + Brachiaria cruciformis Poaceae + + Bulbostylis barbata Cyperaceae + + Caesulia axillaris Asteraceae - + Cardiospermum helicacabum Sapindaceae - + Cassia occidentalis Caesalpinaceae - + Cassia tora Caesalpinaceae + + Cassia absus Caesalpinaceae + + Catharanthus pusillus Apocyanaceae - + Celosia argentea Amaranthaceae + + Chamaesyce indica Euphorbiaceae - + Chamaesyce serpens Euphorbiaceae - + Chamaesyce thymifolia Euphorbiaceae - + Chamaesyce hirta Euphorbiaceae + + Chloris barbata Poaceae + + Chloris montana Poaceae + + Chloris villosa Poaceae + + Chrozophora rottleri Euphorbiaceae + + Cleome gynandra Cleomaceae + + Cleome aspera Cleomaceae + + Cleome viscosa Cleomaceae + + Commalina benghalensis Commelinaceae - + Corchorus tridens Tiliaceae - + Croton bonplandianus Euphorbiaceae + + Cyperus compressus Cyperaceae + + Cyperus difformis Cyperaceae - + Cyperus exaltatus Cyperaceae - + Cyperus iria Cyperaceae - + Cyperus rotundus Cyperaceae + + Dactyloctenium aegyptium Poaceae + + Digera arvensis Amaranthaceae + + Digera muricata Amaranthaceae + + Digitaria ciliaris Poaceae + + Dinebra retroflexa Poaceae + + Echinochloa colona Poaceae - + Echinochloa crusgalli Poaceae - + Echinochlpa procera Poaceae + + Eclipta alba Asteraceae + + Enocostemma axillare Gentianaceae + + Euphorbia heterophylla Euphorbiaceae - + Evolvulus alsionoides Convolvulaceae + + Fimbristylis bisumbellata Cyperaceae - - Fimbristylis miliacea Cyperaceae - +



Name of the weed Family Plant site Buffer area Fimbristylis ovata Cyperaceae - + Fimbristylis quinquangularis Cyperaceae - + Fuirena ciliaris Cyperaceae - + Gomphrena celosioides Amaranthaceae + + Gomphrena globosa Amaranthaceae + + Goniogyna hirta (Heylandia latebrosa) Fabaceae - + Hedyotis puberula (Oldenlandia umbellata)

Rubiaceae + +

Heliotropium ovalifolium Boraginaceae + + Hibiscus lobatus Malvaceae - + Hibiscus platanifolius Malvaceae - + Hygrophila auriculata Acanthaceae - + Indigofera linifolia Fabaceae + + Indigofera linnii Fabaceae + + Indigofera tinctoria Fabaceae + + Indoneesiella echinoids (Andrographis echinoids)

Acanthaceae + +

Justicia procumbens Acanthaceae + + Kyllinga bulbosa Cyperaceae - + Lagascea mollis Asteraceae - + Leucas aspera Lamiaceae + + Limnophyton obtusifolium Alismataceae - + Ludwigia perennis (=L.parviflora) Onagraceae - + Malachra capitata Malvaceae - + Malvastrum coromandelianum Malvaceae - + Melochia corchorifolia Tiliaceae + + Monochoria vaginalis Pontederiaceae - + Oxalis corniculata Oxalidaceae - + Parthenium hysterophorus Asteraceae + + Paspalum distichum Poaceae + + Pavonia zeylanica Malvaceae + + Phyla nodiflora Verbenaceae - + Phyllanthus maderaspatensis Euphorbiaceae + + Phyllanthus virgatus Euphorbiaceae + + Phyllanthus amarus Euphorbiaceae + + Physalis minima Solanacae - + Polygala arvensis Polygalaceae + + Portulaca tuberosa Portulacaceae - + Portulaca oleracea Portulacaceae + + Portulaca quadrifida Portulacaceae - + Psoralea corylifolia Fabaceae - + Schoenoplectus auriculatus Cyperaceae - + Schoenoplectus lateriflorus Cyperaceae - + Setaria pumila Poaceae - + Sida acuta Malvaceae + + Sida corifolia Malvaceae + + Sida rhombifolia Malvaceae + + Solanum surattense Solanacae + + Solanum nigrum Solanacae - +



Name of the weed Family Plant site Buffer area Sopubia delphinifolia Scrophulariaceae - + Spermacoce pusilla Rubiaceae + + Spermacoce articularis (Borreria hispida)

Rubiaceae + +

Sphaeranthus indicus Asteraceae + + Sphenoclea zeylanica Sphenocleaceae - + Stemodia viscosa Scrophulariaceae - + Striga angustifolia Scrophulariaceae + + Tephrosia villosa (=T.hirta) Fabaceae + + Tephrosia procumbens Fabaceae + + Tephrosia purpurea Fabaceae + + Tragia plukenitti Euphorbiaceae - + Tragus roxburghii Poaceae + + Trianthema portulacastrum Aizoaceae + + Trianthema triquetra Aizoaceae + + Tribulus terrestris Zygophyllaceae + + Trichodesma sedgwickianum (=T.amplexicaule)

Boraginaceae + +

Tridax procumbens Asteraceae + + Triumfetta rhomboidea Tiliaceae + + Triumfetta rotundifolia Tiliaceae + + Urochloa panicoides Poaceae + + Vernonia cineria Asteraceae - + Vigna trilobata (Phaseolus trilobatus) Fabaceae + + Waltheria indica Tiliaceae + + Withania somnifera Solanacae + + Xanthium strumarium Asteraceae + +

3.7.4 Terrestrial Fauna

As the vegetation is sparse and as there is lot of human activity and biotic

disturbances, no wildlife except the common wild and domesticated animal species

were found. There are a few common resident birds and no exotic migratory bird

habitats occur in the study area. As there are no reserve forests, sanctuaries or

wildlife habitats and as the area is widely cultivated, there are no wild animals of

REET category. A list of Mammals, Reptiles, Aves and Amphibians found or known

to occur in the study area are given in Table 3.20. All the species reported are of

common and widespread occurrence.

Table 3.20 List of vertebrate species either found or known to occur in the study area

Common name Latin name Vernacular name Schedule Mammals Monkey Macaca mulatto Kothi II Three striped squirrel Petaurista palmarum Ground squirrel IV



Common name Latin name Vernacular name Schedule Common Mongoose Varanus indicus Mungisa IV Fox Vulpes bengalensis Guntanakka IV Greater Bandicoot Bandicota indica Pandikokku IV House rat Mus muscuius Yeluka IV Indian field rat Mus booduga Yeluka IV Indian flying fox Pteropus giganteus Gabbilam IV Indian hare Lupus nigricollis Kundelu IV Jackal Canis aureus Nakka IV Lesser Bandicoot Bandicota bengalensis Pandikokku IV Wild boar Sus scroffa Adivi pandi III Reptiles Sand boa Eryx johni Rendu thalala

pamu

Krait Bungarus caeruleus Katla pamu Not listed Russell’s viper Vipera russseli Raktha pinjari Not listed Rat snake Ptyas mucosus. Jerripothu Not listed Tree Snake Dryphis sp. Chettu pamu Not listed Blind Snake Typholops sp. Guddi pamu Not listed Monitor lizard Veranus monitor. Udumu IV Chameleon Chameleon zeylanicus Usaravilli IV Wall lizard Hemidactylus flaviviridis Balli Not listed Garden lizard Calotes versicolor Tonda Not listed Fresh water turtle Trionxy sp. Neetitabelu IV Indian star tortoise Testudo elegans Mettatabelu IV Aves Cormorant Phalacrocorax higher, Cheruvukkai IV Crow Corvus splendens Kaaki V Jungle Crow Corvus macrohyuchos Advikaki IV Crow pheasant Centrpus sinesis Mohka IV Cuckoo Cuculus varus Kokila IV Ring Dove Streptopelia decactao Kapothamu IV Cattle Egret Bubulcus ibis Egret IV Egret, Little Egretta garetta Karchi Eagle IV Koel Eudynamis scolopaceus Kokila IV Munia, Spotted Lonchura striata Tetai Munia IV Munia,White-Throated Lonchura malabarica Sar munia IV Myna, Black-headed Sturnus pagodarun Goruvanka IV Myna, common Acridothers trists Saada goruvanka IV Owlet Barred Jungle Galuciddum radiatuum, Adavi gudlaguba IV Owl, Spotted Athene brama Gudlaguba IV Parakeet Large Indian Psittacula eupatria Chiluka IV Parakeet, Rose-ringed Psittacula krameri Ramachiluka IV Partridge, Grey Francolinus pondicerianus Chakoramu or

Kouju IV

Pigeon, Blue Rock Columbia livia, Kabuther IV Pigeon, Green Treron pheoenicoptera, Pavuramu IV Indian Robin Saxicoloides fulicata Kalchuri IV Swift, house Apus affinis Babila IV Swallow, common Hirando rustica, Babil or IV



Common name Latin name Vernacular name Schedule Vanakovela

Water hen Amauromis phoenicurus Neeti kodi IV Weaver Bird, common Ploceus philippinus Baya IV Amphibians Ordinary frog Rana hexadactyla. Kappa IV South Indian Toad Bufo melonosticatus Godrukuppa IV Tree Frog Hyla arboria Chettu kappa IV Burrowing frog Cacopus bystema Burada kappa IV Tiger Frog Rana tigrina Kappa IV

3.7.5 Aquatic Flora and Fauna

There are no large rivers or perennial reservoirs in and around the project site within a

radius of 10 Km; the area is not an important habitat for aquatic flora or fauna. But

there are a few tanks and seasonal streams as well as a large number of ditches and

puddles which collect flood water during the rainy season. In addition to these village

tanks, drains, and paddy fields provide the aquatic habitat for a variety of very

common aquatic plants and animals. As the entire plant site is dry owing to the failure

of monsoon, there are no aquatic plants except a few semi aquatic species. All the

species listed in Table 3.21 is found in the study area only. All the species recorded are

common and none of them comes under REET category. A list of macrophytes found in

the area is given in Table 3.22.

Table 3.21 List of aquatic / semi aquatic macrophytes found in the study area

Latin name Family Status Alternanthera philoxeroides Solanaceae Predominant Aponogeton natans Aponogetonaceae Common Azolla pinnata Azollaceae Scattered and common Brachiaria mutica Poaceae Sporadic Carex cruciata Cyperaceae Occasional Centella asiatica Apiaceae In localized patches Chrysopogon aciculatus Poaceae Occasional Colocassia esculenta Araceae Occasional Cynodon dactylon Poaceae Extensive and widespread Cyperus arenarius Cyperaceae Locally abundant Cyperus exaltatus Cyperaceae Locally abundant Echinochloa colona Poaceae Occasional Eichhornia crassipes Pontederiaceae Extensive and widespread Hydrilla verticillata Hydrocharitaceae Prevalent Ipomoea aquatica Convolvulaceae Extensive and widespread Ludwigia perennis Onagraceae Occasional Marsilia quadrifoliata Marsiliaceae Very common Pteridophyte Nelumbo nucifera Nelumbiaceae Very common



Latin name Family Status Nymphaea nauchali Nympheaceae Widely scattered Nymphoides hydrophylla Nympheaceae Scattered Nymphoides indica Nympheaceae Scattered Ottelia alismoides Hydrocharitaceace Widely scattered Oxalis corniculata Oxalidaceae Occasional Paspalidium geminatum Poaceae Common Phragmites karka Cyperaceae Dominant along boundaries Pistia stratoides Araceae Widespread Salvinia cucullata Salviniaceae Common Typha angustata Typhaceae Extensive and widespread Vallisneria spiralis Hydrocharitaceae Widespread

Table 3.22 List of fishes either caught by the fisherman or reported from the study area

Common name Latin name Catla Catla catla Rohu Labeo rohita Murrel Channa striatus Murrel Channa punctatus Wallago Wallago attu Cat fish Mystus vittatus Cat fish Hetyeropneustes fossilis Mrigal Cirrhinus mrigala Tilapia Oreochromis mossambicus Murrel Channa striatus Murrel Channa punctatus Eel Anguilla bengalensis Cat fish Mystus vittatus Cat fish Hetyeropneustes fossilis



CHAPTER 4.0 IDENTIFICATION OF IMPACTS

4.1 Identification of Impacts

Identification of Impacts is one of the basic analytical steps of EIA for subsequent

prediction and evaluation of impacts. A number of methodologies are available for

the identification of impacts. `Net Work Method,' which follows the “Cause-

Condition-Effect” relationship, is adopted for identifying impacts due to the

proposed expansion of API manufacturing facility.

The generation of cause - condition - effect networks (chain of events) is

advantageous in recognizing the series of impacts triggered by the plant and its

expansion activities. Thus this method has provided a “road mass” type of approach

to the identification of second and third order effects.

The idea was to account for the project activity and identify the different types of

impacts that would initially occur. The next was to select each impact and identify

the impacts. The main advantage of this approach is that it allowed identifying the

impacts by selecting and tracing out the events as they may occur.

4.2 Impact Networks

The purpose of identifying the impacts is that it aids in making appropriate decision

to mitigate adverse consequences if any. It may be pointed out that the distinction

between magnitude and importance of impact should be appreciated. Thus the

degree of extensiveness and scale of impacts and the consequences based on value

judgments are generalized while identifying impacts; as it is imperative that the

impact will normally lead to a chain of reactions. The construction of network charts

brings out to certain extent the appropriate levels of risks that may occur due to the

interventions while interacting with hydrological, biological and social systems.

Figure 4.1 to 4.6 present the identified impacts for various components of

environment viz. air, noise, water, land and socio economic aspects. In the above-

mentioned Figure the lines mean -- "has an effect on."

4.2.1 Air Environment

The primary impact of air pollutants will be on the air quality. The chemical

composition of air may change drastically if dispersion is slow. This will lead to, if



pollution is for a shorter period, immediate health problems. If it continues for a

long period, it may also have an impact on climatic changes, ecological equilibrium

and economic production of crops. The impacts on air environment from the

expansion of the project shall be due to utility emissions, process emissions, diffuse

and fugitive emissions consisting of pollutants ranging from particulate matter to

VOC. The impacts due to the proposed expansion shall be felt mainly within the

plant area and the immediate surroundings. There shall be an increase in ambient

air concentrations, unless mitigative and control measures are adopted. The

mitigative and control measures of air pollution shall ensure that the impact on air

quality is local – within the site area and its surroundings, with low magnitude,

medium term duration (during plant operation), and an irreversible impact.

4.2.2 Water Environment

The impacts on water environment are due to abstraction of ground water, effluents

from process, utilities and domestic sources, and spillage of chemicals, effluents and

solid wastes during storage, transfer and due to spillages of the same. The impact of

these activities are both direct and indirect effecting both soil and water quality

leading to deterioration of production levels of both terrestrial and aquatic flora and

fauna, resulting in higher concentrations of chemicals in food chain. The impacts on

surface water quality shall be neutral, reflecting locally within the site, with low

magnitude short term impact mainly due to spillage scouring during monsoon

season’s first rain, which is reversible in short term. The impact on hydrology is

neutral as the proposed expansion does not involve any major construction activity.

The impact on hydrogeology shall be negative as it is proposed to utilize

groundwater in addition to recycled water for expansion, resulting in impacts at

regional level with medium magnitude for a medium term, continuous frequency,

and is reversible in the long term, contingent on the adoption of mitigation

measures.

4.2.3 Noise Environment

The impacts on noise environment are due to mechanical activities, and operation of

pumps, motors, and compressors, resulting in increased ambient noise levels.



Excessive noise will trigger health risks such as headaches, depression, deafness and

retardation of sensory mechanisms in the impact area population. The increase in

noise levels shall have neutral impact, restricted to within site area due to its low

magnitude and occasional frequency.

4.2.4 Land Environment

The change in the land use during and after construction phase is unavoidable.

However as long as it is not affecting the soil quality chemistry and sedimentation,

the impact is not an undesirable one. At the secondary level the impact will lead to

change of agricultural production and livestock. The proposed expansion does not

involve any major construction activity. The impact on land environment is mainly

due to accidental spillages of chemicals, effluents and wastes. The expansion project

has neutral impact on land environment, terrain and soils as there is no additional

land requirement, and the impacts if any are restricted to within the site with

negligible magnitude and is felt mainly during expansion work only. The

operational phase impacts shall be neutral due to effective implementation of

mitigative measures in handling, storing and transferring wastes, effluents and

chemicals.

4.2.5 Biological Environment

The particulate matter and chemical compounds tend to alter soil matrix and water

quality. The impact will be on the native biota leading to density reduction and

extinction of sensitive species. There may be change in the species diversity and food

chain. The expansion activity does not involve disturbance of land or habitat. The

impact on biological environment is neutral with the effect confined mainly to the

site area with low magnitude for a medium term with isolated frequency. There will

be neutral effect on wildlife as the project impact area is mainly suburban in nature.

4.2.6 Socio-economic Environment

Primarily, the impact is expected on the economic environment. The project

generates jobs both during construction and operation stages. There is scope of

multiplier effect on secondary and tertiary employment. The socio economic

structure will have a positive change and quality of life would improve due to



increase in urbanization and cosmopolitanism. The expansion shall have positive

impact on socioeconomic environment due to provision of employment both direct

and indirect and proposed CSR activities. The impact is positive and long term

contingent on the financial success of the project.

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4.3 Prediction of Impact on Air Quality

4.3.1 Details of Mathematical Modeling

A large number of different mathematical models for dispersion calculations are in

practice in many parts of the world. Most of the models for prediction of downwind

concentrations are based on Gaussian dispersion. The principle behind the Gaussian

dispersion models is Gaussian probability distribution of concentration in both

vertical and horizontal cross wind directions about the plume central line.

Predictions of ground level concentrations of the pollutants were carried out based

on site meteorological data collected during the study period. For calculation of

predicted ground level concentrations, ISCST3 model of Lakes Environmental based

on USEPA, ISCST3 algorithms, was used; as it’s based on more sophisticated

algorithm incorporating deposition, better algorithm for area sources, etc.

Brief History of the ISC Models

The ISC3 models are based on revisions to the algorithms contained in the ISC2

models. The latter came about as a result of a major effort to restructure and

reprogram the ISC models that began in April 1989, and was completed in March

1992. The reprogramming effort was largely motivated by the need to improve the

quality, reliability, and maintainability of the code when numerous "bugs" were

discovered after the implementation of the revised downwash algorithms for shorter

stacks. However, the goals of the reprogramming effort also included improving the

user interface by modifying the input file structure and the output products.

Overview of New Features in the ISC3 Models

The ISC3 models include several new features. A revised area source algorithm and

revised dry deposition algorithm have been incorporated in the models. The ISC3

models also include an algorithm for modeling impacts of particulate emissions from

open pit sources, such as surface coal mines. The Short Term model includes a new

wet deposition algorithm, and also incorporates the COMPLEX1 screening model

algorithms for use with complex and intermediate terrain. When both simple and

complex terrain algorithms are included in a Short Term model run, the model will

select the higher impact from the two algorithms on an hour-by-hour, source-by-



source, and receptor by- receptor basis for receptors located on intermediate terrain,

i.e., terrain located between the release height and the plume height.

Some of the model input options have changed and newer input options have been

added as a result of the new features contained in the ISC3 models. The source

deposition parameters have changed somewhat with the new dry deposition

algorithm, and there are new source parameters needed for the wet deposition

algorithm in the Short Term model. There are also new meteorology input

requirements for use of the new deposition algorithms. The option for specifying

elevation units has been extended to source elevations and terrain grid elevations, in

addition to receptor elevations.

The utility programs, STOLDNEW, BINTOASC, and METLIST have not been

updated. While they may continue to be used as before, they are not applicable to

the new deposition algorithms in the ISC3 models. The salient features of the

ISCST3 model are presented below in Table 4.1.

Table 4.1 Salient Features of the ISCST3 Model S.No Item Details

1 Model name ISCST3 (Based on USEPA algorithm) 2 Source Types Point, Area, Volume, Open Pits 3 Dispersion Equation Steady State Gaussian Plume Equation 4 Diffusion Parameters Pasquill Gifford Co-efficient 5 Plume Rise Briggs Equation 6 Time Average 1 hr to Annual/Period Has Short Term and Long Term

modeling options 7 Deposition Both Dry and Wet Deposition 8 Application Input Data: (i) Source Data Stack co-ordinates (ii) Receptor Data Grid interval, number of receptors, receptor elevations (iii) Meteorological

Data Hourly meteorological data i.e. wind speed, direction, ambient temperature, stability and mixing heights

4.3.1.1 Model Formulation

The model uses the following steady state Gaussian plume equation. The basic

equation for calculating the concentration of pollutants for any point in x, y, z co-

ordinates is given below:

C(x,y,z,H) = Q/2π σy σz U exp[-1/2(y/σy)2] x [exp{-1/2(z-h/σz)2} + exp{-1/2 (z+H/σz)2}]



Where C= Concentration of pollutants in mg/cu m Q= Strength of emissions in g/sec. H= Effective Height (m), i.e., physical height + plume raise y, z= diffusion coefficients in y and z directions in m. U= average wind velocity in m/sec. The following assumptions are made in Gaussian dispersion model.

This model assumes no diffusion in the down wind direction and thus applicable to

a plume and not a puff of pollutant. The dispersion parameter values used for

horizontal dispersion coefficient and vertical dispersion coefficients are those given

in the “Work book of atmospheric dispersion estimates”. These dispersion

coefficients assume a sampling time of about 10 min., the height values of interest to

be in the lowest several hundred meters of the atmosphere, a surface corresponding

to the open country. The stacks are tall enough to be free from building turbulence

so that no aerodynamic down wash occurs. The given stability exists from ground

level to well above the top of the plume.

The Gaussian dispersion model has been tested extensively for its validity and found

to be reasonably applicable for different atmospheric conditions. BIS has also

adopted this basic plume dispersion model. Hence the same model is adopted for

predictions of downwind concentrations of pollutants in this report.

4.3.1.2 Meteorological Data

Data recorded by the weather monitoring station at site on wind speed, direction,

solar insolation, temperature and cloud cover at one hourly interval for three months

i.e. One full season has been used for computations.

Mixing Height

The mixing heights for ambient air quality predictions are adopted from Atlas of

Hourly Mixing Height and Assimilative Capacity of Atmosphere in India by S.D

Attri, Siddartha Singh, B. Mukhopadhya and A.K Bhatnagar, Published by Indian

Metrological Department, New Delhi. 2008. The mixing heights range from 300 to

1450 m during summer season. There is no record of inversion for this area

(Reference: Atlas of Hourly Mixing Height and Assimilative Capacity of



Atmosphere in India by S.D Attri, Siddartha Singh, B. Mukhopadhya and A.K

Bhatnagar, Published By Indian Metrological Department, New Delhi. 2008). There

is no record of inversion in this area as observed from the IMD data.

4.3.2 Plant Emissions

The sources of air pollution from the plants of M/s. Hazelo Lab Pvt.Ltd., and the

following units in the surrounding which sought expansion in the recent months,

i.e., SVR Laboratories Pvt. Ltd, Chemic Life Sciences (P) Ltd., V.J. Sai Chem and

Optimus Drugs Pvt. Ltd., are boilers and DG sets. The major pollutants generated

from the fuel combustion are SO2, NOx and Particulate Matter. Based on fuel

analysis and combustion details the emission rates of above pollutants are

calculated. The emission rates of SO2, NOx and Particulate Matter from each stack

are presented in Table 4.2.



Table 4.2 Emission Details of Pollutants from Stack S. No Stack Connected to Stack

Ht (m) Dia of

stack at top(m)

Temp. of exhaust gases

(0C)

Exit Velocity (m/sec)

Pollutant Emission Rate (g/sec)

PM SO2 NOx Hazelo Lab Pvt. Ltd

Existing 1 2TPH + 0.6TPH Coal Fired Boilers 15 1 180 4.5 1.12 0.04 0.13 2 1 lakh k. cal/hr Thermic fluid heater 15 0.32 127 7.96 0.16 - 0.004

3** 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01 Proposed

1 2 x 10TPH Coal Fired Boilers 35 1.45 190 6.05 0.63 0.72 0.3 2** 2 x 1000KVA DG Set 10 0.2 180 8 0.01 0.02 0.03

SVR Laboratories (P) Ltd Existing

1* 1TPH Coal Fired Boiler 15 1 180 4.5 0.56 0.24 0.25 2** 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01

Proposed 1 5TPH Coal Fired Boiler 30 0.5 130 8.5 0.12 0.04 0.03 2* 4TPH Coal Fired Boiler 25 0.5 125 7.2 0.096 0.032 0.024 3 4.0 Lac K. Cal Thermic Fluid Boiler 10 0.25 165 8.23 0.05 0.14 0.18

4** 2 x 1000KVA DG Set 10 0.15 151 13.86 0.01 0.02 0.03 Optimus Drugs Pvt. Ltd.

Existing 1 3 TPH Coal Fired Boiler 28 0.6 180 8.5 0.15 0.21 0.42 2 1.5 TPH Coal Fired Boiler 30 0.32 127 7.96 0.32 - 4.00E-04 3 2 x 500 KVA DG Set** 2 0.1 144 1.5 0.002 0.001 0.005

Proposed 1 2 x 6 PH Coal Fired Boilers 30 0.9 130 6.05 0.12 0.06 0.05

4** 1 x 1000KVA DG Set 10 0.15 151 13.86 0.01 0.02 0.03 VJ Sai Chem

Existing 1* 1TPH Coal Fired Boiler 15 1 180 4.5 0.56 0.24 0.25 2** 125KVA DG Set 2.5 0.1 250 5 0.003 0.001 0.006

Proposed



1 5TPH Coal Fired Boiler 30 0.5 130 8.5 0.12 0.04 0.03 2 500KVA DG Set 5 0.15 165 7.5 0.06 0.18 0.25

3** 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01 * shall be kept as standby ** DG set will be used during load shut down.

Effective stack height for 10 TPH Coal Fired Boiler On PM Basis - Coal Fired Boiler Units Capacity

Boiler Capacity TPH 10 Coal Consumption Kg/hr 2056 Coal Consumption TPD 49.34 Ash Generation @ 45% of consumption TPH 0.93 Fly ash (5% of total Ash) TPH 0.05 Stack Height Calculated (PM) H= 74*(Q0.27) m 32.27 On SO2 Basis - Coal Fired Boiler Sulphur Content in Coal % (by wt. Max.) 0.45% SO2 Emission Rate Kg/hr 18.5 Stack Height Calculated (SO2) H= 14*(Q0.3) m 33.6

Hence it is proposed to provide a 35 m height stack for the coal fired boiler.

Effective Stack height for 1000 KVA DG set DG Set Capacity 1000 KVA Stack Height Calculated H= 0.2(KVA)0.5 6.32 m

Hence it is proposed to provide a 10 m height stack for DG set.



4.3.2.1 Diffuse Emissions

Emissions are also released from various operations of manufacturing like

centrifuge, drying, distillation, extraction etc. These emissions mainly contain

volatile contents of the material sent for processing. The emissions are normally

passed through vent scrubber before releasing into atmosphere to mitigate odour.

The emissions from distillation are passed through condensers, which mitigate

odour. It is proposed to provide vent condensers in series to reactors, distillation

columns, driers and centrifuge etc. to mitigate VOC emissions release. Other vents

are connected to common headers and scrubbers. The transfer pumps shall be

provided with mechanical seals. The transfer of solvents shall be mainly by closed

pipeline systems, while drum transfer is by using air operated diaphragm pumps in

closed hoods. The effluent storage tank is a major source of diffuse VOC emissions,

and it is proposed to provide a closed tank for initial storage of untreated effluents,

with a scrubber connected to the storage tank vent.

4.3.2.2 Fugitive Emissions

Fugitive emissions are anticipated from equipment leakage and transfer spills. The

periodic maintenance program shall ensure integrity of equipment mitigating

equipment leakage. The spills however shall be managed by adopting the spill

management scheme as mentioned in the respective MSDS, spill control kit shall be

provided in storage, and production blocks. The fugitive emissions shall be reduced

by closed transfer and handling of all hazardous solvents and chemicals. The

ventilation system provided will reduce health impact on the employees by way of

dilution of work room air and also dispersion of contaminated air.

4.3.2.3 Air Quality Predictions (Terms of Reference No. 7(i)

Predictions of ground level concentrations of the pollutants were carried out based

on site meteorological data collected during the study period. For calculation of

ground level concentrations a grid of 10 km X 10 km with a receptor interval of 400

meters is considered.

The composition of particulate matter was obtained from USEPA AIRCHIEF AP-42

and the same was considered in determining the source concentration of PM10 and

PM2.5 for prediction purpose. The predicted maximum 24 hourly ground level



concentrations of Suspended Particulate Matter, PM10, PM2.5, SO2 and NOx and

distance of occurrence during different seasons of study period are presented in

Table 4.3.

It may be observed that the annual predicted maximum 24 hourly GLC’s of PM,

PM10, PM2.5, SO2 and NOx are 3.50, 1.43, 0.67, 5.2 and 7.48 μg/m3 respectively and the

maximum values are observed at a distance of 0.4 km from the center of plant site in

northwest direction. However it may be noted that the predicted values of the SO2

and NOx are based on the assumption that the DG sets are used constantly, where as

the DG set usage is only during load shut down from Southern distribution

company of Telangana limited.

The GLC’s are also predicted at air quality monitoring locations and the predicted

GLC’s are presented in Tables 4.4 and the cumulative concentrations at various

villages are tabulated in Table 4.5. It may be observed from the Table that the

predicted results show that the incremental rise over existing base line status of

ambient air quality is within the limits prescribed by CPCB for residential and rural

areas. Hence the control measures and height of stack is sufficient to disperse the

pollutants into the atmosphere and keeping the baseline levels within the prescribed

limits. The predicted ground level concentrations are graphically displayed for SPM,

PM10, PM2.5, SO2, and NOx respectively in Figure 4.7 – 4.11.

Table 4.3 Maximum Predicted 24 hourly GLC’s

S.No Parameter Predicted GLC (μg/m3) Distance (KM) Direction 1 SPM 5.97 0.5 NW 2 PM10 2.33 0.5 NW 3 PM2.5 1.05 0.5 NW 4 SO2 5.88 0.5 NW 5 NOX 6.19 0.5 NW



Table 4.4 Predicted GLC’s at Monitoring Locations S.No Monitoring

Location Direction Distance

(Km) Predicted GLC (μg /m3)

SPM PM10 PM2.5 SO2 NOx

1 Antammagudem W 1.3 1.68 0.67 0.30 1.70 2.37 2 Dhotigudem NW 1.7 1.26 0.50 0.23 1.56 2.00 3 Yellagiri SW 2.4 0.21 0.08 0.04 0.46 0.19 4 Lakkaram SE 4 0.30 0.12 0.05 0.23 0.26 5 Chinna Kondur NE 5.5 0.23 0.09 0.04 0.47 0.28 6 Jalalapur NW 7.0 0.68 0.27 0.12 0.51 0.73 7 Koyalgudem SE 3.4 0.20 0.08 0.04 0.45 0.17

Reserved Forests 1 Lakkaram RF SE 0.8 1.53 0.61 0.28 1.70 1.29 2 Chauttuppal RF NW 4.7 0.35 0.14 0.06 0.32 0.36 3 Malkapuram RF SW 2.6 1.31 0.52 0.24 0.49 0.70 4 Hafizpura RF SW 6.8 0.51 0.20 0.09 0.37 0.56 5 Ailaupur RF SW 6.9 0.18 0.07 0.03 0.13 0.18 6 Meharnagar RF NW 5.2 0.54 0.22 0.09 0.48 0.58 7 Jalalpur RF NW 7.1 0.54 0.22 0.10 0.49 0.63



Table 4.5 Cumulative Concentrations at Various Villages and Reserved Forests Station Direction Distance

(Km) Baseline Concentration

(μg/m3) Predicted GLC (μg/m3) Cumulative Concentration

(μg/m3) PM10 PM2.5 SO2 NOx PM10 PM2.5 SO2 NOx PM10 PM2.5 SO2 NOx

Antammagudem W 1.3 44 17 11 13 0.67 0.30 1.70 2.37 44.67 17.30 12.70 15.37 Dhotigudem NW 1.7 43 18 11 13 0.50 0.23 1.56 2.00 43.50 18.23 12.56 15.00 Yellagiri SW 2.4 42 16 10 13 0.08 0.04 0.46 0.19 42.08 16.04 10.46 13.19 Lakkaram SE 4.0 40 16 10 11 0.12 0.05 0.23 0.26 40.12 16.05 10.23 11.26 Chinna Kondur NE 5.5 44 17 11 13 0.09 0.04 0.47 0.28 44.09 17.04 11.47 13.28 Jalalapur NW 7.0 39 18 11 12 0.27 0.12 0.51 0.73 39.27 18.12 11.51 12.73 Koyalgudem SE 3.4 47 16 11 13 0.08 0.04 0.45 0.17 47.08 16.04 11.45 13.17 Reserve Forests Lakkaram RF SE 0.8 0.61 0.28 1.70 1.29 0.61 0.28 1.70 1.29 Chauttuppal RF SE 4.7 0.14 0.06 0.32 0.36 0.14 0.06 0.32 0.36 Malkapuram RF SW 2.6 0.52 0.24 0.49 0.70 0.52 0.24 0.49 0.70 Hafizpura RF SW 6.8 0.20 0.09 0.37 0.56 0.20 0.09 0.37 0.56 Ailaupur RF SW 6.9 0.07 0.03 0.13 0.18 0.07 0.03 0.13 0.18 Meharnagar RF NW 5.2 0.22 0.09 0.48 0.58 0.22 0.09 0.48 0.58 Jalalpur RF NW 7.1 0.22 0.10 0.49 0.63 0.22 0.10 0.49 0.63



Figure 4.7 Isopleths Showing 24 Hourly GLC’s of SPM



Figure 4.8 Isopleths Showing 24 Hourly GLC’s of PM10



Figure 4.9 Isopleths Showing 24 Hourly GLC’s of PM2.5



Figure 4.10 Isopleths Showing 24 Hourly GLC’s of SO2



Figure 4.11 Isopleths Showing 24 Hourly GLC’s of NOX



4.3.2.4 Prediction of Concentration of Solvents in the Indoor Environment Due to

Solvent Loss and Fugitive Emissions

A simple Box Model (EVAPMOD) was used to calculate the solvent concentration in

the indoor environment. The methodology adopted was to calculate the

concentration for the product group which has the largest amount of solvent losses.

General Box Model:

Indoor air pollution models developed and used by USEPA and others consider the

conservation of air contaminant mass in a volume or "box" of workroom air.

Airborne concentrations are derived by solving the following general equation (Jay

jock, 1988):

C = (Ain - Aout) / Volume of Box ---------- (1) Where

C = Concentration at time ti (assume C=0 @ t0 = 0) Ain = Mass of contaminant that went into the box during time interval ti - t0 Aout = Mass of contaminant that left the box during time interval ti - t0

The diffusion coefficient and the generation rate of the contaminant were calculated

to arrive at the airborne concentration in the environment.

For the General Ventilation Model, the overall estimate of the airborne concentration

of a contaminant is obtained by use of following equation.

Cv = (1.7*105) Ta*G M*Q*m

Where: C v = Contaminant concentration in workplace (ppm) Ta = Ambient temperature of the air (°K) G = Vapor generation rate (gm/sec) M = Molecular Weight (gm/gm-mole) Q = Ventilation rate (ft3/min) m = Mixing factor (dimensionless) Higher solvent loss and the predicted airborne concentrations of the various solvents

are tabulated in the Table 4.6.



Table 4.6 Solvent Loss and the Predicted Airborne Concentrations

S.No Name of Solvent Fugitive Loss

(Kg/day)

cv ppm

TLV (ppm)

1 Acetic acid 4.8 2.4 10 2 Acetone 95.7 48.9 1000 3 Acetonitrile 2.0 1.4 40 4 Chloroform 34.0 8.4 50 5 Di isopropyl ether 20.0 5.8 250 6 Dichloromethane 84.8 29.6 50 7 Dimethyl Formamide 17.5 7.1 10 8 Dimethyl sulfoxide 17.5 6.6 50 9 Ethanol 63.2 40.6 1000

10 Ethyl acetate 112.3 37.8 400 11 Ethylene Dichloride 7.0 2.1 10 12 Hexane 18 6.2 50 13 Isopropyl alcohol 72.4 35.7 400 14 Methanol 92.9 86.0 200 15 N,N Dimethyl Acetamide 5.3 1.8 10 16 Tetrahydrofuran 25.0 10.3 200 17 Toluene 160.3 51.6 200 18 Methyl Iso Butyl Ketone 6.2 1.8 100 19 Monochlorobenzene 2.5 0.9 75 20 n-Butanol 18.3 9.3 100 21 N-Methyl-2-Pyrrolidine 2.5 0.7 540 22 Triethyl Amine 0.9 0.3 5

4.4 Prediction of Impact on Noise Quality

The sound pressure level generated by noise source decreases with increasing

distance from the source due to wave divergence. An additional decrease in sound

pressure levels also occurs with increasing distance from the source due to

atmospheric effect or interaction with the objects in the transmission path. This is

due to excess attenuation. The sound pressure level is also affected by medium of

travel and environmental conditions. The propagation model has been devised to

take into account these factors and predict the noise levels at various distances round

a single or a multiple source. The model uses the following formula as a basis for

such predictions.

(Lob) = (Lr) - (Ldiv) - (Latm) Where (Lob) = Observed noise level at a distance R from source (Lr) = Noise level of source measured at reference distance r (Ldiv) = Loss due to divergence at distance R from source



= 20 log (R/r) (Latm) = Attenuation due to atmosphere at distance R from the source. = a x R/100, where a is atmospheric attenuation coefficient in dB (A)/100m.

For hemispherical wave divergence in a homogenous loss free atmosphere (Latm) = 0.

The total impact of all sources at particular place is then estimated by adding as the contribution of noise from each of the following sources as follows; i=n (Lob)i/10 (Leq) = 10 log Σ {10 } i=1

Where n = total number of sources

The calculated noise levels are further super imposed (logarithmically) on the

background noise levels. The model assumes that the noise spectrum is mainly

centered on a spectrum of 1000 Hz and attenuation due to building materials is also

at the same frequency.

The major source of noise generation is DG set which emit noise level of maximum

90 dB (A) at a reference distance of 1m from the source. The predicted cumulative

noise levels due to the source and the existing level as calculated from the

logarithmic model without noise attenuation ranged between 55 and 75 Db (A) at

distances ranging between 8 to 15 m which falls within the plant boundary. There is

no residential area in the immediate surroundings of the plant up to a distance of 650

meters. The impact of noise on the population in the surrounding area will be

negligible.

4.5 Prediction of Impact on Water Quality

Water is essentially used for process, utilities and domestic purposes. The total fresh

water required of quantity 250.73 KLD after expansion will be drawn from ground

water in addition to recycled water of 175 KLD. No impact on water quality is

expected due to the discharge of effluents as zero liquid discharge in envisaged,

which ensures reuse of treated effluents for cooling tower makeup and scrubbers.

There is no usage of treated water for on land irrigation. The impact on

hydrogeology shall be negative as it is proposed to utilize ground water resulting in

impacts at regional level with medium magnitude for a medium term, continuous

frequency, and is reversible in the long term.



4.6 Prediction of Impact on Soil

The overall impact on soil is negligible as the treated effluent is not used for green

belt development, and the solid waste generated at various stages and ash are sent to

TSDF. Hazardous wastes and spillage of chemicals and wastewater may not

contaminate the soil and ground water, if necessary mitigation measures are

adopted. Green belt development surrounding the plant site would improve soil

quality and surrounding ecology and aesthetic appeal of the area. Trees will absorb

specific air pollutants, reduce noise pollution, reduce soil temperature, help in

holding moisture in the soil, attract more birds and overall will help in maintain the

homeostasis of the environment. Avenue plantation and greenbelt shall significantly

improve the environmental quality The enhancement of green belt density as part

of the expansion shall have positive impact in the long term.

4.7 Prediction of Impact on Socio Economics

The overall impact on the socio economic status is very positive, as the accrued

benefits are both direct and indirect. The direct benefits are increase in employment,

escalation of land prices due to increased activities and improved infrastructure,

which in turn have a bearing on the productivity, industrialization and socio

economic status of the surrounding area in particular and the state in general.

4.8 Impacts of the Industry on Flora and Fauna

The ecological factors that are considered most significant as far as the impact on

flora and fauna concerned are:

1. Whether there shall be any reduction in species diversity?

2. Whether there shall be any habitat loss or fragmentation?

3. Whether there shall be any additional risk or threat to the rare or endangered or

endemic or threatened (REET) species?

4. Whether there shall be any impairment of ecological functions such as

(i) disruption of food chains,

(ii) decline in species population and or

(iii) alterations in predator-prey relationships?

5. Whether it is possible to attain the global objectives of ‘no net loss’ of biodiversity?



6. Whether it is possible to improve the biological diversity through the proposed

activity?

There is no direct threat to to any rare or endangered or threatened biological species

as indicated by the baseline data, due to the proposed expansion project, as it entails

least impact on vegetation. The project is not going to cause any fragmentation of

habitat or disruption of food cycles or destruction of breeding grounds or blockade of

migratory routes. The major impacts of the project are mainly during construction

and subsequently on account of atmospheric pollution. The industry is required to

limit its emissions as per the NAAQ of 2009. It has to strictly adhere to the conditions

stipulated by the regulatory bodies. The project authorities are going to take all steps

and measures in order to strictly comply with National Ambient Air Quality

Standards of 2009. The project may not have impacts on terrestrial flora and fauna.

Further, as there are no rare or endangered or threatened (REET) species within the

impact area, the project does not pose any direct threat to the survival of any rare

species. Hence, the proposed project activity is unlikely to pose any additional threat

to REET species either in the impact area.

4.9 Prediction of Impact on Vehicular Traffic

As the plant is located 2.8 km from the national highway there will not be any

unauthorized shop or settlements along the road connecting the plant site. The

traffic density of the adjacent road is medium mainly consisting of local agro

produce transport, commercial and passenger vehicle traffic. Raw materials and

finished products are transported by road using road trucks. The additional traffic

generated due to the establishment of the plants shall be 10-12 truck trips per day.

There will be marginal increase in the traffic density.


Team Labs And Consultants 5-1

5.0 ENVIRONMENTAL MONITORING

5.1.1 Introduction

The environmental monitoring programme provides such information on which

management decision may be taken during construction and operation phases. It

provides basis for evaluating the efficiency of mitigation and pollution control

measures and suggest further actions that need to be taken to achieve the desired effect.

The monitoring includes:

(i) Visual observations;

(ii) Monitoring of environmental parameters at specific locations;

(iii) Sampling and regular testing of these parameters.

5.1.2 Objectives

The objectives of the environmental monitoring programme are:

• Evaluation of the efficiency of mitigation and pollution control measures;

• Updating of the actions and impacts on baseline data;

• Adoption of additional mitigation measures if the present measures are

insufficient;

• Generating the data, which may be incorporated in environmental

management plan in future projects.

5.1.3 Methodology

Monitoring methodology covers the following key aspects:

• Components to be monitored;

• Parameters for monitoring of the above components;

• Monitoring frequency;

• Monitoring standards;

• Responsibilities for monitoring;

• Direct responsibility,

• Overall responsibility;

• Monitoring costs.



Environmental monitoring of the parameters involved and the threshold limits

specified are discussed below for the proposed expansion of synthetic organic

chemicals (Bulk drug manufacturing) unit of M/s. Hazelo Lab Pvt. Ltd. The plant

installed remote camera system for the ZLD facility.

5.1.4 Ambient Air Quality (AAQ) Monitoring

Ambient air quality parameters recommended are PM10, PM2.5, Oxides of Nitrogen

(NOX) and Sulphur Dioxide (SO2). These are to be monitored at designated locations

starting from the commencement of construction activity. Data should be generated at

all identified locations in accordance to the National Ambient Air Quality Standards

(Table 5.1) location, duration and the pollution parameters to be monitored and the

responsible institutional arrangements are detailed out in the Environmental

Monitoring Plan.

Table 5.1 National Ambient Air Quality Standards S.No Pollutant Time

Weighted Average

Concentration in Ambient Air

Industrial, Residential, Rural and

Other Area

Ecological Sensitive Area

(Notified by Central

Government)

Methods of Measurement

1 Sulphur Dioxide (SO2)

Annual* 24 Hours**

50

80

20

80

Improved west and GaekeUltraviolet fluorescence

2 Nitrogen Dioxide (NO2)

Annual* 24 Hours**

40

80

30

80

Modified Jacob & Hochheiser (Nn-Arsenite) Chemiluminescence

3 Particulate Matter (Size Less than 10 µm) or PM10

Annual* 24 Hours**

60

100

60

100

Gravimetic TOEM Beta Attenuation

4 Particulate Matter (Size Less than 2.5µm) or PM2.5

Annual* 24 Hours**

40

60

40

60

Gravimetic TOEM Beta Attenuation

5 Ozone (O3) 8 hours** 1 hour**

100

180

100

180

UV Photometric Chemilminescence Chemical Method

6 Lead (Pb) Annual* 24 hours**

0.50

1.0

0.50

1.0

AAS /ICP method after sampling on EPM 2000 or equivalent filter paper ED-XRF using Teflon filter.

7 Carbon Monoxide (CO)

8 hours**

02

02

Non Dispersive Infra Red (NDIR)



1 hour** 04 04 Spectroscopy 8 Ammonia

(NH3) Annual* 24 hours**

100 400

100 400

Chemilminescence Indophenol blue method

9 Benzene (C6H6) Annual* 05 05

Gas Chromotography based continuous analyzer Absorption and Desorption followed by GC analysis

10 Benzo (o) Pyrene(BaP) – Particulate Phase only,

Annual* 01 01 Solvent extraction followed by HPLC/GC analysis

11 Arsenic (As), Annual* 06 06 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper

12 Nickel (Ni), Annual* 20 20 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper

*Average Arithmetic mean of minimum 104 measurement in a year taken for a week 24 hourly at uniform interval.

**24 hourly/8 hourly values should meet 98 percent of the time in a year 5.1.5 Water Quality Monitoring

The physical and chemical parameters recommended for analysis of water quality

relevant are pH, total solids, total dissolved solids, total suspended solids, oil and

grease, COD, chloride, lead, zinc and cadmium. The location, duration and the

pollution parameters to be monitored and the responsible institutional arrangements

are detailed in the Environmental Monitoring Plan. The monitoring of the water quality

is to be carried out at all identified locations in accordance to the Indian Standard

Drinking Water Specification – IS 10500: 1991 (stated in Table 5.2)



Table 5.2 Indian Standard Drinking Water Specifications – IS: 10500:1991 S. No Substance or

Characteristics Requirement

(Desirable Limit)

Undesirable Effect Outside the Desirable Limit

Perm

issi

ble

Lim

it in

the

Abs

ence

of

Alte

rn Methods of Test (Ref. To IS)

Remarks

ESSENTIAL CHARACTERISTICS 1 Colour, Hazen

units, Max. 5 Above 5, consumer

acceptance decreases 25 3025 (Part 4)1983 Extended to 25 only if toxic

substances are not suspected, in absence of alternate sources

2 Odour Unobjectionable - - 3025 (Parts5):1984 a) Test cold and when heated b) Test at several dilutions

3 Taste Agreeable - - 3025 (Part 7& 8)1984 Test to be conducted only after safety has been established

4 Turbidity NTU, Max.

5 Above 5, consumer acceptance decreases

10 3025 (Part 10)1984 -

5 pH Value 6.5 to 8.5 Beyond this range, the water will affect the mucous membrane and/or water supply system

No relaxation 3025 (Part 11)1984 -

6 Total hardness (as CaCO3) mg/l, Max

300 Encrustation in water supply structure and adverse effects on domestic use

600 3025 (Part 21)1983 -

7 Iron (as Fe) mg/l, Max

0.3 Beyond this limit taste/appearance are affected, has adverse effect on domestic uses and water supply structures, and promotes iron bacteria

1 32 of 3025 : 1964 -

8 Chlorides (as CI) mg/l, Max

250 Beyond this limit, taste, corrosion and palatibility are affected

1000 3025 (Part 32)1988

-



S. No Substance or Characteristics

Requirement (Desirable

Limit)


Perm

issi

ble

Lim

it in

the

Abs

ence

of

Alte


Remarks

9 Residual, free chlorine, mg/l, Min

0.2 - - 3025 (Part 26)1986 To be applicable only when water is chlorinated. Tested at consumer end. When protection against viral infection is required, it should be Min 0.5 mg/l

DESIRABLE CHARACTERISTICS 1 Dissolved solids

mg/l, Max 500 Beyond this palatability

decreases and may cause gastro intestinal irritation

2000 3025 (Part 16)1984 -

2 Calcium (as Ca) mg/l, Max

75 Encrustation in water supply structure and adverse effects on domestic use

200 3025 (Part 40)1991 -

3 Magnesium (as Mg), mg/l, Max

30 Encrustation to water supply structure and adverse effects on domestic use

100 16, 33, 34 of IS 3025: 1964

-

4 Copper (as Cu) mg/l, Max

0.05 Astringent taste, discoloration and corrosion of pipes, fitting and utensils will be caused beyond this

1.5 36 of 3025: 1964 -

5 Manganese (as Mn) mg/l, Max

0.1 Beyond this limit taste/appearance are affected, has adverse effects on domestic uses and water supply structures

0.3 35 of 3025: 1964 -

6 Sulphate (as 200 SO4) mg/l, Max

200 Beyond this causes gastro intestinal irritation when

400 3025 (Part 24) 1986 May be extended up to 400 provided (as Mg) does not





Limit)


Perm

issi

ble

Lim

it in

the

Abs

ence

of

Alte


Remarks

magnesium or sodium are present

exceed 30

7 Nitrate (as NO2) mg/l, Max

45 Beyond this, may cause methaemoglobinemia

100 3025 (Part 34) 1988 -

8 Fluoride (as F) mg/l, Max

1 Fluoride may be kept as low as possible. High fluoride may cause fluorosis

1.5 23 of 3025: 1964 -

9 Phenolic compounds (As C6H5OH) mg/l, Max

0.001 Beyond this, it may cause objectionable taste and odour

0.002 54 of 3025: 1964 -

10 Mercury (as Hg) mg/l, Max

0.001 Beyond this, the water becomes toxic

No relaxation (see Note) Mercury ion analyzer

To be tested when pollution is suspected

11 Cadmium (as Cd), mg/l, Max


No relaxation (See note) To be tested when pollution is suspected

12 Selenium (as Se), mg/l, Max


No relaxation 28 of 3025: 1964 To be tested when pollution is suspected

13 Arsenic (As As) mg/l, max


No relaxation 3025 (Part 37) 1988


14 Cyanide (As CN), mg/l, Max

0.05 Beyond this limit, the water becomes toxic

No relaxation 3025 (Part 27) 1986


15 Lead (as Pb), mg/l, Max

0.05 Beyond this limit, the water becomes toxic

No relaxation (see note) To be tested when pollution is suspected

16 Zinc (As Zn). Mg/l, Max

5 Beyond this limit it can cause astringent taste and an opalescence in water

15 39 of 3025: 1964) To be tested when pollution is suspected

17 Anionic detergents (As

0.2 Beyond this limit it can cause a light froth in water

1 Methylene-blue extraction method






Limit)


Perm

issi

ble

Lim

it in

the

Abs

ence

of

Alte


Remarks

MBAS) mg/l, Max

18 Chromium (As Cr6+) mg/l, Max

0.05 May be carcinogenic above this limit

No relaxation 38 of 3025: 1964 To be tested when pollution is suspected

19 Poly nuclear aromatic hydrocarbons (as PAH) g/1, Max

- May be carcinogenic above this limit

- - -

20 Mineral oil mg/l, Max

0.01 Beyond this limit un-desirable taste and odour after chlorination take place

0.03 Gas Chromatographic method

-

21 Pesticides mg/l, Max

Absent Toxic 0.001 - -

22 Radioactive materials: 58 of 3025:01964 - 23 a) Alpha emitters

Bq/l, Max - - 0.1 - -

24 Beta emitters pci/1, Max

- - 1 - -

25 Aluminium (as Al), mg/l, Max

200 Beyond this limit taste becomes unpleasant

600 13 of 3025:1964 -

26 Aluminium (as Al), mg/l, Max

0.03 Cumulative effect is reported to cause dementia

0.2 31 of 3025: 1964 -

27 Boron, mg/l, Max 1 - 5 29 of 3025: 1964 - Source: Indian Standard Drinking Water Specification-IS10500:1991



5.1.6 Noise Level Monitoring

The measurements for monitoring noise levels would be carried out at all designated

locations in accordance to the Ambient Noise Standards formulated by Central

Pollution Control Board (CPCB) in 1989 (refer Table 5.3) Sound pressure levels would

be monitored on twenty-four hour basis. Noise should be recorded at a “A” weighted

frequency using a “slow time response mode” of the measuring instrument. The

location, duration and the noise pollution parameters to be monitored and the

responsible institutional arrangements are detailed in the Environmental Monitoring

Plan (Table 5.3)

Table 5.3 Noise level standards (CPCB) Type Noise level for Day Noise level for Industrial area 75 70 Commercial area 65 55 Residential area 55 45 Silence zone 50 40 Day time - 6.00 am - 9.00 pm (15 hours)

The monitoring plan along with the environmental parameters and the time frame is

presented in the Table 5.4.

Table 5.4 Environmental Monitoring Plan (Terms of Reference No. 7 (xii))

S. No

Particulars Monitoring Frequency

Standards Duration of

Sampling

Important monitoring parameters

Ambient Air Quality Monitoring 1 Industry

Main Gate, Antammagudem Dhotigudem villages

Quarterly Air (Prevention and Control of Pollution) Rules, CPCB, 1994

24 hrs PM10, PM2.5, SO2, Nox, & VOC

2 Work Place Monitoring : Production blocks 6 locations, Solvent Tankfarm, and ETP area

Quarterly 8 hr SPM, VOC

Stack Emissions Monitoring 1 Utility Stacks : 2 nos. Coal

fired boilers, 1 Thermic Fluid Heater and 3 no.s DG sets.

Quarterly Air (Prevention and Control of Pollution) CPCB, 1994

-- PM, SO2, Nox , recommended methods of CPCB.

Water Quality Monitoring 1 Process water Daily Water Quality

standards by CPCB

Grab pH, TDS, SS, BOD, COD and Oil & Grease Hardness, , chlorides, using APHA or BIS analytical methods.



2 Effluents Stream wise Quarterly Grab pH, TDS, SS, BOD, COD using APHA or BIS analytical methods.

3 Treated effluent after ZLD

Daily Grab pH, TDS, TSS, COD, BOD and Oil and Grease using APHA or BIS analytical methods.

Noise Quality Monitoring 1 Noise Levels at 3 Locations

with in plant site and 2 locations outside the plant site , Antammagudem Dhotigudem villages

Quarterly Noise stan-dards by CPCB

24 hrs Equivalent Noise levels in dB(A)

Soil Quality Monitoring 1 Soil - 3 locations within the

site; storage area, near production blocks (6no.s) and ETP area.

Once a year pH, EC, CEC, Lead, Moisture, Texture, Bulk Density etc.

5.1.7 Responsibility of Monitoring And Reporting System

The overall responsibility of monitoring the above parameters shall lie with the

management of Hazelo Lab Pvt. Limited. The maintenance/environment wing shall be

responsible for day to day monitoring of effluent, raw water and treated water quality.

The Ambient air quality, Stack emissions, soil, noise and water quality shall be

monitored by either third party or by the Environment management division of the

unit.

Records shall be maintained for the analysis of raw effluents and treated effluents,

ambient air quality data, stack emissions monitoring results, micro- meteorological data

and noise levels. These records are not only required for the perusal of the Pollution

Control Board authorities but also to derive at the efficiencies of the pollution control

equipment as the objective of the project proponent is not only compliance with

statutory regulations, but also a serious commitment towards clean environment.

The industry shall maintain the records as per the hazardous waste regulations and

EPA regulations and apply for the annual consents for air and water, and renewal of

authorization for the storage of hazardous waste as per Hazardous Waste (Handling &

Management) Rules, 1989. The records of hazardous waste manifest will be

maintained.



Reporting system provides the necessary feedback for project management to ensure

quality of the works and that the management plan in implementation. The rationale

for a reporting system is based on accountability to ensure that the measures proposed

as part of the Environmental Management Plan get implemented in the project.

5.1.7.1 Work Zone Monitoring for Hazardous Chemicals (Terms of Reference No. Sp. TOR (4))

Periodic Workzone monitoring is adopted to review the indoor toxic chemicals

concentration. The periodicity of monitoring is dependent on the concentrations i.e.,

below or above TLV values.

5.2 Environmental Monitoring Budget

The environmental budget for the various environmental management measures in the

EMP is detailed in Table 5.5. There are several other environmental issues that have

been addressed as part of good engineering practices, the costs for which have been

accounted for in the Engineering Costs. Moreover, since environmental enhancements

have not been finalized at this stage, the table projects the typical costs unit wise.

Table 5.5 Environmental Monitoring Budget Particulars Monitoring

Frequency Unit Cost

Rs. Annual Cost

Rs. Ambient Air Quality Monitoring Monthly 4500 162000 Work Place Monitoring Monthly 2000 192000 Stack Emissions Monitoring Monthly 2700 97200 DG Set Stack Emissions Monitoring Quarterly 2700 32400 Process water Daily 500 165000 Effluents - Stream wise Quarterly 600 4800 Treated effluent (ETP water) Daily 600 198000 Noise Level Monitoring Quarterly 1000 20000 Soil Quality Once a year 2000 22000 Total (Rs.) 893400

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