report industrial training (chok)

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REPORT OF INDUSTRIAL TRAINING HOVID BERHAD 121 JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIA. CHOK JIA YEE 911210-08-5215 A11SC0151 3-SSCC FACULTY OF SCIENCE UNIVERSITI TEKNOLOGI MALAYSIA 16 JUNE - 5 SEPTEMBER 2014

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experience during internship for HOVID company, learnt a lot of new things

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REPORT OF INDUSTRIAL TRAINING

HOVID BERHAD121 JALAN TUNKU ABDUL RAHMAN, 30010 IPOH,PERAK,MALAYSIA.

CHOK JIA YEE911210-08-5215A11SC01513-SSCC

FACULTY OF SCIENCEUNIVERSITI TEKNOLOGI MALAYSIA16 JUNE - 5 SEPTEMBER 2014

CONTENT

DescriptionPage

Dedication/AppreciationAbbreviationExecutive Summary3

45

Introduction7

Chapter 1 : Company Background10

Chapter 2 : Overview of Training Given14

Chapter 3 : Specific Information of Training19

3.1Uniformity of Weight (UOW)20

3.2Friability21

3.3Disintegration Time (DT)22

3.4Optical Rotation (OR)22

3.5pH Meter22

3.6Titration25

3.7Thin-Layes Chromatography (TLC)27

3.8Atomic Absorption Spectrometry (AAS)32

3.9Ultra Violet and Visible Spectrophotometry (UV-Vis)39

3.10High Performance Liquid Chromatography (HPLC)42

3.11Fourier Transform Infrared (FTIR)44

Chapter 4 : Conclusion50

Chapter 5 : Problems and Suggestions 51

Referrences52

Appendixes53

18

DEDICATION/APPRECIATIONFirst of all, the special thank goes to my helpful supervisor, Mr. Tai Wen Xi, QC Chemist of Hovid Bhd. The supervision and support that she gave me truly help my progression and smoothness of the industrial training program. The co-operation is much indeed appreciated. My grateful thanks also go to Mrs. Choy Wai Peng, QC Manager and Encik Johari Amran, Senior QC Executive of Hovid Bhd, and all staff under QC department namely Mr. Ng Choon Heng, Mrs. Chon Huey Chian, Mrs. Vipushini A/P Subramaniam , Mrs. Suguneswary A/P Marimuth, Mrs. Rohana Bt. Mohd Marzuki, that help and assisting me in completing this practical training. A big contribution and hard worked from the staffs during this twelve weeks is very great indeed. The lessons during the program would be nothing without the enthusiasm and imagination from them.

In addition, this industrial training program makes me realized and practicing values that I gained during my life such as discipline, respect each other, punctuality. The whole program really brought us together to appreciate the true value of friendship and respect of each other. Great deals appreciated go to the contribution of my faculty, Faculty of Science (FS). I am also would like to thankful the faculty adviser, Dr. Roswanira Abdul Wahab because her visitation during industrial training program. Last but not least I would like to thank my friends especially those who work together as staffs in Hovid Bhd. I am amazed by confidence from their trustees. I truly enjoy to be trained at Hovid Bhd. and appreciate their commitment given to me . Millions of thanks to my parents and all who include in the industrial training program to give encourage, support and help me in completing this program successfully.

LIST OF ABBREVIATION

AASAtomic Absorption spectroscopyBPBritish PharmacopoeiaCRMCertified Reference MaterialDTDisintegration TimeFTIRFourier Transfrom InfraredGC MSGas ChromatographyIHIn House methodIRMInternal Reference MaterialLODLimit of DetectionLOQLimit of QuantitationMDMVMethod Development and Method ValidationOROptical RotationQCQuality ControlTLCThin-Layer ChromatographyUOWUniformity of WeightUSPUnited State PharmacopoeiaUV-VisUltra-violet and Visible Absorption Spectrophotometry

EXECUTIVE SUMMARYDuring twelve weeks of industry training, I was assigned to Quality Control Department of Hovid Bhd, under the supervision of Mr. Tai Wen Xi, QC Chemist of Hovid Bhd. Besides that, Encik Hakim from Human Resources have provided a orientation to me about the history of Hovid Bhd. First of all, Mrs Suguneswary A/P Marimuth, Senior Supervisor of Hovid Bhd under Finished Product have taught me how to do physical test which is Uniformity of Weight (UOW) for tablets and capsules, diameter of round tablets and length of capsules measured, friability, Optical Rotation (OR), pH Meter and Disintegration Time (DT) on the finished product. Then, I have been trained by Mrs Suguneswary A/P Marimuth about Identification test by using FTIR, TLC or observation, Related Substance test by using UV-Vis, TLC or HPLC and Assay test by using UV-Vis or HPLC on the finished product.Next, I have been trained on how to check and discard the released items which has been tested last month for the finished product. The label of the sample must be tore off from the pack to avoid any illegal used by others and the samples will be packed altogether to further discard. I also trained to prepare some test reagent which can be used within 6 months only. Besides that, I have been trained by Mr Ahmad Lattiffi B.Yahaya, Lab assistant about Sensitivity test by using AAS for Cadmium and Lead. Then, My supervisor, Mr Tai has given a project which is about the method development for identification of Montelukast Winthrop Tablet by using FTIR which has been doing for three weeks. Meanwhile, I have been trained by Mrs Vipushini A/P Subramaniam, QC Chemist under Method Development and Method Validation about Linearity test, Precison for Repeatability, Limit of Detection and Limit of Quantitation test on the particular sample.In addition, I read about the ISO/IEC 17025: 2005 which is using by Hovid Bhd and the Laboratory Quality Manual of Hovid Bhd. Mr Tai teached me how to renew and check about protocol which has expired by using Microsoft word, all protocol should be renew and check after 3 years. The method or procedure of the test which is using in protocol is referred to In House method (IH), British Pharmacopoeia (BP) or United State Pharmacopoeia (USP). Furthermore, I try to prepare a new protocol by using Microsoft word and it is referred to a hard copy of the original protocol. Next, I have learned to prepare spreadsheet calculation of Uniformity of Dosage (weight variance) by using Microsoft Excel and report of validation for the spreadsheet by using Microsoft Word. Then, I read and study about the British Pharmacopoeia 2014 (BP). Meanwhile, I read and studied about the Standard Operating Procedure (SOP). Next, I have attended the internal training program by Encik Johari about the Physical Appearance of Finished Products and In-Process Quality Control Program (IPQC). This internship program have made it possible for me to gain more advance knowledge in quality control. Consequently, I have comprehended the significance of checking and maintaining the quality of the products. Quality Control Department is to uphold the reputation of the companys quality of the products. Hence, several tasks will be carried out as documented in order to eliminate any errors. On the other hand, it is divided to three sections which is finished product, method development and method validation and raw material. This help QC department more easier to monitor their job.Besides some technical skills that I practiced in Hovid Bhd., I also honed my communication and cooperation with the colleagues. The efficiency of the teams performance cannot be achieved if the members are lack of cooperation and coordination. Hence it is vitally important for the employee are fully equipped with those skills. Conclusively speaking, Hovid Bhd. provides an ideal environment and is a suitable for students to undergo their industrial training. Though it was just a few weeks of training, I have gained experiences and knowledge regarding to chemistry related field.

INTRODUCTIONThe Industrial Training refers to work experience that is relevant to professional development in future of the students. Having the industrial training is a good change to expose the students with real life experience working in a company. So, the students can apply their theoretical learning in university to their real life works in a company. In others word, the industrial training is to develop the knowledge and the skills of students to be more aware of the needs and expectations to achieve high quality skill in future. All students who are registered for a Bachelor of Science in Industrial Chemistry in UTM are required to undergo Industrial Training for a period of 12 weeks after year 3.

Objectives of Industrial TrainingBelow are some objectives of industrial training : To expose the students in the working environment. To get the working experience in the organization. To apply knowledge get from the working experience in the study process in university. Training good communication and interaction among the students and workers. Training the students to provide the technical report of the industrial training. To develop group working attitude in students. Understanding ethics of the profession in working life. To produce professionals who are responsible to their Creator and the society. To produce professionals who are very well trained, skilled and efficient through the establishment of excellent academic programs. To establish good university-industry relationship. To develop and establish high quality academic and support personnel. To create an excellent environment for consultancy, research and development activities.

Scope of Industrial TrainingScope is the experience that will be through by the students in many aspects. The scopes of the industrial training consist of: - Leadership Enterpreneurship Ethics and integrity Communication skills Teamworking Life-long learning Critical thinking and problem solving

Summary of Industrial TrainingIndustrial training is compulsory to each students for graduation requirement for the undergraduate students within 12 weeks in an organization. Industrial Training in UTM is normally accumulated during the semester breaks at the end of the third year. Students should note that Industrial Training is an essential component in the development of the practical and professional skills required of a Chemist and an aid to prospective employment. Many employers regard this period as a chance to get new employees for future employment.Generally, all students should make considerable effort and give sufficient thought into obtaining the most relevant and effective Industrial Training. So, it is desirable to obtain experience in a range of activities given, such as handling the instrument, watching work operation, assembly the components, analyze data, writing report and so on. It should also be noted that developing an awareness of general workplace behavior and interpersonal skills are important objectives of the Industrial Training.In order to accomplish the industrial training target, I have applied my industrial training place at Hovid Bhd, Chemor plant and I was succeed to start my learning process there. Starting 16th of June and finish at 5th of September 2014. There are lots of experiences I have gained on chemistry aspects especially quality control, method development and method validation. From the program, undergraduate students could achieve many benefits of working field in the selected company. So, the knowledge that they got from the program could be applied in the future.

CHAPTER 1COMPANY BACKGROUND

Hovid (formerly known as Ho Yan Hor) carries with her years of invaluable experience in the pharmaceutical industry.Dating back to early 1940s, when the business was first established, Hovid's only commodity was Ho Yan Hor Herbal Tea, concocted by its founder, Dr Ho Kai Cheong. With the intention of helping people, Dr Ho Kai Cheong formulated a unique concoction of 24 specially chosen herbs and developed Ho Yan Hor Herbal Tea. It was a popular alternative to western medicine during post World War II with its Cooling and Anti Viral properties. Ho Yan Hor Herbal Tea was the most seek after solution during the Worldwide Flu Epidemic in 1950s. Since then, Ho Yan Hor has become a household name. After 74 years, Ho Yan Hor Herbal Tea still remains as the favorite among many as a natural herbal beverage.In the 1980s, along with his father's success, David Ho, as a well trained pharmacist, led Hovid into a new chapter of manufacturing excellence. Armed with expertise in pharmacy with strong passion of entrepreneurship, David ventured into mainstream medical approaches. From that point on, Hovid grew to become one of the Malaysia's leading pharmaceutical manufacturers of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed over 50 countries globally.Listed on the Main Board of Kuala Lumpur Stock Exchange, Hovid spells familiarity and quality among healthcare providers. With the various divisions in the organization that have been established through years of experience, we are able to deliver speed, excellence and above all, Continuous Innovation and Quality.The company's reputation for pioneering and technological advancements has scored many firsts: FIRST in Malaysia and the world to have developed a commercial scale integrated process for extracting valuable carotenoids and tocotrienols (type of vitamin E with superior properties over tocopherols) from palm oil FIRST in the world to develop the self-emulsifying SupraBio system for improved absorption of tocotrienols in the human body. FIRST soft gelatin encapsulation plant in Malaysia with pioneer status from the Ministry of International Trade and Industry FIRST in Malaysia to produce film-coated analgesic FIRST in Malaysia to produce softgel capsules FIRST in Malaysia to produce effervescent tablets FIRST in Malaysia to produce antibiotics in dispersible tablet form FIRST in Malaysia to have developed patented technologies in drug delivery systems FIRST in Malaysia to pack herbal tea in dried form and easy to use teabags

Hovid Bhd.s Logo

Hovids SpiritsMessage from Manager Director for the launching of Hovids spiritsFor more than 70 years, Hovid has demonstrated the commitment to perform. At the same time we have expanded into new businesses and new regions and built sustained growth. Nevertheless, we need to have better equipped to operate in the rapidly changing environment and the extremely competitive world today.We aim to embrace the GMP fulfilment, Lean practices and innovation to develop and produce the world class quality pharmaceutical products and services at all time. The reputation grows along when we believe in working together with mutual respect, effective communications and integrity while heading towards our goal and direction hand in hand.

I ask each person in the Hovid community to make a personal commitment to follow our corporates spirits. All of us must tie up with the 5 core corporate spirits, which they are Respect, Communication, Teamwork, Innovation and Ethical & Honest as these spirits will guide us in upholding our ethical commitments for achieving greater performances and excellent results.The excellent financial performance and high standards of corporate spirits are mutually reinforcing. As we focus on becoming the preeminent growth company at present and future, we must recognize that integrity will maintain our reputation, increase our customers confidence and enable us to continue to grow and achieve greater height in both personal and professional accountability.

CHAPTER 2OVERVIEW OF TRAINING GIVEN

Week 1 :During my first week of industrial training, I have introduced to Encik Johari, Senior QC Executive about QC department. He introduced me to the member of QC and QA department, this is due to QC and QA department is located in the same office. He also guided me to walk around in the surrounding of QC department and introduced me about the equipment of QC department. He told me that each using of the equipment by lab assistant or chemist must be recorded in the log book provided for date, time, product name, batch number, user id and method used. All the equipments and machines in QCs lab will be validated by the technician of Hovid Bhd. Some equipment such as balance will be validated daily, but some equipment like oven will validated weekly or monthly. Besides that, Encik Hakim from Human Resources have provided a orientation to me about the history of Hovid Bhd. Then, I started to enter the lab to learn and observe their labs work. Mrs Suguneswary A/P Marimuth, Senior Supervisor of Hovid Bhd under Finished Product have taught me how to do physical test which is Uniformity of Weight (UOW) for tablets and capsules (Refer to 3.1). I also have been trained about how to do other physical test which are diameter of round tablets and length of capsules measured, friability (Refer to 3.2), disintegration time (Refer to 3.3) and identification by using FTIR (Refer to 3.10).Week 2 :During my second week, I have introduced to Mr. Tai Wen Xi, QC Chemist of Hovid Bhd as my supervisor during my Industrial Training. I have been trained on how to check and discard the released items which has been tested last month. The label of the sample must be tore off from the pack to avoid any illegal used by others and the samples will be packed altogether to further discard. Apart from that, I have been trained to do UOW for cream and powder (Refer to 3.1). Then, I have been trained by Mrs Rohana Bt. Mohd Marzuki about the identification of Hosolvon Tablet by observe the colour changing for Part B and C. For Part B (Characteristic of Bromides), we dissolved the sample which equivalent to 100 mg of Bromhexine Hydrochlorine in 5 ml of 5 M Ammonia and followed by extraction by using two 20 ml quantities of Chloroform and 5 ml of Purified Water. Then, the separated extraction was filtered through Anhydrous Sodium Sulpate and evaporated the filtrate to dryness. The residue was mixed with 1 g of Sodium Carbonate and heated at a dull red heat. Next, the residue was allowed to cool and extracted again with 10 ml of Purified Water. The filtrate acidified with 2 M Nitric Acid and added 0.4 ml of Silver Nitrate Solution R1, then it was shook well and allowed to stand. A curdy, pale yellow precipitate was produced. The precipitate was centrifuged and washed with three 1 ml quantities of Purified Water. Lastly, the precipitate obtained was suspended in 2 ml of Purified Water and added 1.5 ml of 10 M Ammonia. The precipitate dissolved with difficulty. For Part C (Characteristic of Chlorides), the sample which equivalent to 20 mg of Bromhexine Hydrochloride was dissolved with 10 ml of Methanol and filtered with Whatman filter paper No.1. The filtrate was acidified with 2 M Nitric Acid and added 0.4 ml of Silver Nitrate Solution R1, shook well and allowed to stand. A curdy, white precipitate is produced. The precipitate was centrifuged and washed with three 1 ml quantities of Purified Water immediately. 1.5 ml of 10 M Ammonia was added, the precipitate dissolves easily with the possible exception of a few large partices which dissolve slowly. I also trained to prepare some test reagent which can be used within 6 months only.Week 3 : During this period, I have been trained by Mr Ahmad Lattiffi B.Yahaya to prepare standard, QC check, diluent, and matrix modifier of Cadmium and Lead and do the AAS test for Cadmium and Lead (Refer to 3.8). In addition, I have been trained by Mrs Rohana Bt. Mohd Marzuki about Related Substances of Hosolvon Tablet (Refer to 3.7.7) and Whitfields Ointment by using Thin Layer Chromatography (TLC). Then, My supervisor, Mr Tai has given a project which is about the method development for identification of Montelukast Winthrop Tablet by using FTIR (Refer to 3.11.6). Besides that, Mrs Rohana Bt. Mohd Marzuki has trained me about the Optical Rotaion test of Syrup Simplex (Refer to 3.4). Week 4 :In this week, I continual to do my project which is given by my supervisor by using different solvent to dissolve the active ingredient of Montelukast Winthrop Tablet (Refer to 3.11.6). While I am waiting my sample of Montelukast Winthrop to fully dry, I have trained by Mohd. Sharifuddin B. Rosly about the Related Substance of Timolol Maleate Eyedrops by using HPLC. Besides that, I have learned to do identification of Nizole tablet by observe the colour changing. Next, Mrs Rohana Bt. Mohd Marzuki teached me to do pH test of Mixture Potassium Citrate (Refer to 3.5).Week 5 :For week 5, I have successfully done the project given by my supervisor which is Identification of Montelukast Winthrop Tablet by using FTIR (Refer to 3.11.6). Then, I read about the ISO/IEC 17025: 2005 which is using by Hovid Bhd and the Laboratory Quality Manual of Hovid Bhd. Mr Tai teached me how to renew and check about protocol which has expired by using Microsoft word, all protocol should be renew and check after 3 years. The method or procedure of the test which is using in protocol is referred to In House method (IH), British Pharmacopoeia (BP) or United State Pharmacopoeia (USP).Week 6 :During week 6, I continual to learn about renew and check the protocol by using Microsoft word. Then I try to prepare a new protocol by using Microsoft word and it is referred to a hard copy of the original protocol. Besides that, I have learn about Related Substance of Diamide Tablet by using TLC. Its standard is using Certified Registed Material (CRM), so the standard should be weigh by using microbalance (range 0.0020g- 4g). In addition, I have been trained by Mrs Vipushini A/P Subramaniam about Method validation of Related Substance of Clofenac Sodium (Refer to 3.10.1). This is to determine the Limit of Detection and Limit of Quantitation of the method. Next, I have learned to prepare spreadsheet calculation of Uniformity of Dosage (weight variance) by using Microsoft Excel.Week 7 :This week, Hovid Bhd is closed for two days (28 - 29 July 2014) holiday for Hari Raya celebration. Then, I read and studied about the British Pharmacopoeia 2014 (BP). Study about their purpose, procedure and apparatus on Infrared Spectrophotometry, Ultra-violet and Visible Absorption Spectrophotometry, Atomic Absorption Spectrophotometry, Thin-Layer Chromatography, Gas Chromatography, Optical Rotation, Loss on drying, Disintegration Time, Dissolution, Consistency of Formulated Preparation (UOW) and Friability. I have been trained by Mrs Vipushini A/P Subramaniam about Method validation of Assay of Virest Tablet by using UV-Vis. It is to determine the average result done by different lab assistant. Week 8 :During this week, I have been taught to prepare a report of validation for the spreadsheet calculation of Uniformity of Dosage (weight variance) by using Microsoft Word. Next, I have been trained by Mrs Vipushini A/P Subramaniam about the Linearity of Lipicine Tablet by using UV-Vis. It is to plot a calibration curve graph. Mr Tai Wen Xi has given me a new project which is to determine whether the new matrix modifier can be used on the test of AAS of Lead and Cadmium. Dr. Roswanira Abdul Wahab, supervior from UTM come to visit my supervisor and I. Apart from that, I have been trained by Mrs Suguneswary A/P Marimuth about the Assay Vitamin A of Seven Seas Cod Liver Oil Gold Capsule (Refer to 3.9.2).Week 9 :This week I have observed how was Mohammad Farid B. Rosman, lab assistant doing about the Assay Vitamin A of Seven Seas Cod Liver Oil Gold Capsule. I have sick during this week (12 15 August 2014), I absent for four days with Medical Certificate.Week 10 :For week 10, I have trained by Mrs Vipushini A/P Subramaniam to do Precision check for Assay & Preservative Content of Ducodin Forte Linctus (syrup) BE08155 by using HPLC. This test is to determine the precision for 6 samples which was prepared by same lab assistant, so we can determine the procedure is valid to be used (Refer to 3.10.2). In addition, I have been taught to do Linearity for Lipiduce Tablet by using UV-Vis (Refer to 3.9.1). Then, I read and studied about the Standard Operating Procedure (SOP) of Precision Balance, Analytical Balance, Semi-micro Balance, Micro Balance, Micro Processor Controlled Centrifuge, Automatic Polarimeter, Disintegration Time, Spectrum 100 FT-IR Spectrophotometer, pH Meter, UV Spectrophotometer, Atomic Absorption Spectrometer and High Performance Liquid Chromatography. Next, I have attended the internal training program by Encik Johari about the Physical Appearance of Finished Products and In-Process Quality Control Program (IPQC). Besides, I have trained by Mrs Suguneswary A/P Marimuth about the Identification of Ducodin Forte Linctus (syrup) 15 mg/ 5 ml BE08155. It consisted of Part A and Part B. For the Part A, which is about extraction of the pholcodine (active ingredient), followed by recrystallization and then run FTIR for the residues. For the Part B, which is to obtain observation for their reaction. First, we dissolve the residue in Sulphuric Acid to get pale blue colour, followed by added Ammonium Molybdate Sulphuric Acid and warm gently to get deep blue and then added 2 M Nitric Acid to get brownish red. Furthermore, under MDMV, I trained by Mrs Vipushini A/P Subramaniam about Standardization of 0.01 M Disodium Edetate Solution with Chelometric Standard Calcium Carbonate and Precision for 6 Replicate of Assay of Calactate Tablet BE06666 (Refer to 3.6.1).Week 11 :For week 11, I redo the Standardization of 0.01 M Disodium Edetate Solution with Chelometric Standard Calcium Carbonate and Precision for 6 Replicate of Assay of Calactate Tablet BE06666 (Refer to 3.6.1). This is due to the result is not in the specification. After redo with the same method, we are able to get the result. In addition, I start to do my report which has been halfway done. I also help lab assistant to do some physical tests.Week 12 :Last week, our company has replacement holiday for National Day on Monday, 1 September 2014. Then, I use my remaining time here to complete document, report, task and so on. Besides, I also help lab assistant to do some physical tests.

CHAPTER 3SPECIFIC INFORMATION OF TRAININGIn this chapter, the specific information of the training done will be discussed and will be explained more detail. The information of this chapter consists of the objective of training, implementation of the training, the result of the training and capability of analyzing, solving solution, procedure and training relevance due to the study in UTM. Moreover, some extra information in other aspect about the training done in the organization was provided to widen the scope of chemistry field. There are the laboratory testing in this laboratory : 3.1 Uniformity of Weight (UOW)Weigh individually 20 units taken at random or, for single-dose preparations presented in individual containers, the contents of 20 units, and determine the average mass. Not more than 2 of the individual masses deviate from the average mass by more than the percentage deviation shown in Table 1 and none deviates by more than twice that percentage. For capsules and powders for parenteral use, proceed as described below. 3.1.1 Capsules Weigh an intact capsule. Open the capsule without losing any part of the shell and remove the contents as completely as possible. For soft shell capsules, wash the shell with a suitable solvent and allow to stand until the odour of the solvent is no longer perceptible. Weigh the shell. The mass of the contents is the difference between the weighings. Repeat the procedure with another 19 capsules.Table 1Pharmaceutical FormAverage MassPercentage Deviation

Tablets (uncoated and film-coated)80 mg or lessMore tan 80 mg and less than 250 mg250 mg or more107.5

5

Capsules, granules and powdersLess than 300 mg300 mg or more107.5

Powders for parenteral AdministrationMore than 40 mg10

3.1.2 Powders for Parenteral AdministrationRemove any paper labels from a container and wash and dry the outside. Open the container and without delay weigh the container and its contents. Empty the container as completely as possible by gentle tapping, rinse it if necessary with water R and then with alcohol R and dry at 100-105 C for 1 h, or, if the nature of the container precludes heating at this temperature, dry at a lower temperature to constant mass. Allow to cool in a desiccator and weigh. The mass of the contents is the difference between the weighings. Repeat the procedure with another 19 containers.3.2 FriabilityFor the friability determination of compressed, uncoated tablets. The test procedure presented is generally applicable to most compressed tablets. Measurement of tablet friability supplements other physical strength measurements, such as tablet breaking force. For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding as near as possible to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of 10 whole tablets. The tablets are carefully dedusted prior to testing. Accurately weigh the tablet sample, and place the tablets in the drum. Rotate the drum 100 times, and remove the tablets. Remove any loose dust from the tablets as before, and accurately weigh. Generally, the test is run once. If obviously cracked, cleaved, or broken tablets are present in the tablet sample after tumbling, the sample fails the test. If the results are difficult to interpret or if the weight loss is greater than the targeted value, the test is repeated twice and the mean of the 3 tests determined. A maximum loss of mass (obtained from a single test or from the mean of 3 tests) not greater than 1.0 per cent is considered acceptable for most products. If tablet size or shape causes irregular tumbling, adjust the drum base so that the base forms an angle of about 10 with the horizontal and the tablets no longer bind together when lying next to each other, which prevents them from falling freely. Effervescent tablets and chewable tablets may have different specifications as far as friability is concerned. In the case of hygroscopic tablets, a humidity-controlled environment is required for testing. A drum with dual scooping projections, or apparatus with more than one drum, for the running of multiple samples at one time, are also permitted.3.3 Disintegration Time (DT)Place 1 dosage unit in each of the 6 tubes of the basket and, if prescribed, add a disc. Operate the apparatus using the specified medium, maintained at 37 2 C, as the immersion fluid. At the end of the specified time, lift the basket from the fluid and observe the dosage units: all of the dosage units have disintegrated completely. If 1 or 2 dosage units fail to disintegrate, repeat the test on 12 additional dosage units. The requirements of the test are met if not less than 16 of the 18 dosage units tested have disintegrated.Test 6 tablets or capsules either by using 2 basket-rack assemblies in parallel or by repeating the procedure. In each of the 3 tubes, place 1 tablet or capsule and, if prescribed, add a disc; suspend the assembly in the beaker containing the specified liquid. Operate the apparatus for the prescribed period, withdraw the assembly and examine the state of the tablets or capsules. To pass the test, all 6 of the tablets or capsules must have disintegrated.3.4 Optical Rotation (OR)Determine the zero of the polarimeter and the angle of rotation of polarised light at the wavelength of the D-line of sodium (l = 589.3 nm) at 20 0.5 C, unless otherwise prescribed. Measurements may be carried out at other temperatures only where the monograph indicates the temperature correction to be made to the measured optical rotation. Determine the zero of the apparatus with the tube closed; for liquids the zero is determined with the tube empty and for solids filled with the prescribed solvent.3.5 pH MeterThe pH is a number which represents conventionally the hydrogen ion concentration of an aqueous solution. For practical purposes, its definition is an experimental one. The pH of a solution to be examined is related to that of a reference solution (pHs) by the following equation:

in which E is the potential, expressed in volts, of the cell containing the solution to be examined and Es is the potential, expressed in volts, of the cell containing the solution of known pH (pHs), k is the change in potential per unit change in pH expressed in volts, and calculated from the Nernst equation. Table 3.5.1 Values of k at different temperatures

The potentiometric determination of pH is made by measuring the potential difference between 2 appropriate electrodes immersed in the solution to be examined: 1 of these electrodes is sensitive to hydrogen ions (usually a glass electrode) and the other is the reference electrode (for example, a saturated calomel electrode). 3.5.1 Apparatus:The measuring apparatus is a voltmeter with an input resistance at least 100 times that of the electrodes used. It is normally graduated in pH units and has a sensitivity such that discrimination of at least 0.05 pH unit or at least 0.003 V may be achieved. Table 3.5.2 pH of reference buffer solutions at various temperatures

3.5.2 Method:Unless otherwise prescribed in the monograph, all measurements are made at the same temperature (20-25 C). Table 3.5.2 shows the variation of pH with respect to temperature of a number of reference buffer solutions used for calibration. For the temperature correction, when necessary, follow the manufacturer's instructions. The apparatus is calibrated with the buffer solution of potassium hydrogen phthalate (primary standard) and 1 other buffer solution of different pH (preferably one shown in Table 3.5.2). The pH of a third buffer solution of intermediate pH read off on the scale must not differ by more than 0.05 pH unit from the value corresponding to this solution. Immerse the electrodes in the solution to be examined and take the reading in the same conditions as for the buffer solutions. When the apparatus is in frequent use, checks must be carried out regularly. If not, such checks should be carried out before each measurement. All solutions to be examined and the reference buffer solutions must be prepared using carbon dioxide-free water R. 3.5.3 Preparation of reference buffer solutions: Potassium Tetraoxalate 0.05 M - Dissolve 12.61 g of C4H3KO8,2H2O in carbon dioxide-free water R and dilute to 1000.0 ml with the same solvent. Potassium Hydrogen Tartrate, Saturated at 25 C - Shake an excess of C4H5KO6 vigorously with carbon dioxide-free water R at 25 C. Filter or decant. Prepare immediately before use.Potassium Dihydrogen Citrate 0.05M - Dissolve 11.41 g of C6H7KO7 in carbon dioxide-free water R and dilute to 1000.0 ml with the same solvent. Prepare immediately before use. Potassium Hydrogen Phthalate 0.05M - Dissolve 10.13 g of C8H5KO4, previously dried for 1 h at 110 2 C, in carbon dioxide-free water R and dilute to 1000.0 ml with the same solvent. Potassium Dihydrogen Phosphate 0.025M + Disodium Hydrogen Phosphate 0.025M - Dissolve 3.39 g of KH2PO4 and 3.53 g of Na2HPO4, both previously dried for 2 h at 120 2 C, in carbon dioxide-free water R and dilute to 1000.0 ml with the same solvent. Potassium Dihydrogen Phosphate 0.0087M + Disodium Hydrogen Phosphate 0.0303M - Dissolve 1.18 g of KH2PO4 and 4.30 g of Na2HPO4, both previously dried for 2 h at 120 2 C, in carbon dioxide-free water R and dilute to 1000.0 ml with the same solvent. Disodium Tetraborate 0.01M - Dissolve 3.80 g of Na2B4O7,10H2O in carbon dioxide-free water R and dilute to 1000.0 ml with the same solvent. Store protected from atmospheric carbon dioxide. Sodium Carbonate 0.025M + Sodium Hydrogen Carbonate 0.025M - Dissolve 2.64 g of Na2CO3 and 2.09 g of NaHCO3 in carbon dioxide-free water R and dilute to 1000.0 ml with the same solvent. Store protected from atmospheric carbon dioxide. Calcium Hydroxide, Saturated at 25 C - Shake an excess of calcium hydroxide R with carbon dioxide-free water R and decant at 25 C. Store protected from atmospheric carbon dioxide.Storage- Store buffer solutions in suitable chemically resistant, tight containers, such as type I glass bottles or plastic containers suitable for aqueous solutions.3.6 Titration3.6. 1 Assay of Calactate 300 mg Tablet, BE06666 (IH-TIT-491)Calcium Lactate Pentahydrate Tablet 300 mg, active ingredient is calcium lactate pentahydrate 160 mg/ Tablet and the validation method is by using assay (IH-TIT-491). This test have been done by a few Lab assistant, so we can calculate the different in error do by different lab assistant.3.6.1.1 StandardizationReagent:- Chelometric Standard Calcium CarbonateDiluted Hydrochloric Acid (10%) - 1 ml of concentrated Hydrochloric Acid (12.00 M) in 10 ml volumetric flask, make up to volume with purified water.Sodium Hydroxide TS - 4.0 g of Sodium Hydroxide in 100 ml volumetric flask, make up to volume with purified water.Hydroxyl Naphthol Blue0.01M Disodium Edetate (EDTA) VS - Dissolve 3.72 g of Disodium Edetate in sufficient amount of purified water to produce 1000 ml.Procedure: 0.04 g of Chelometric Standard Calcium Carbonate was weighed, which was previously dried at 110 C for 2 hours and cooled down in a dessicator, into a 250 ml conical flask. Then, 10 ml of purified water was added and swirled to form a slurry or cloudy. The conical flask was covered with a stopper. 2 ml of Diluted Hydrochloric Acid (10%) was pipetted into conical flask through the gap between the conical flask and the stopper. The contents of the conical flask was swirled to dissolve the Calcium Carbonate. Next, it was diluted with purified water to about 100 ml. 30 ml of Disodium Edetate solution was added from a 50 ml burette while stirring the solution with magnetic stirrer. 15 ml of Sodium Hydroxide TS and 0.003 g of Hydroxyl Naphthol Blue were added and continue the titration with Disodium Edetate solution from purple to a blue endpoint. Repeat the step for three replicate. By using this average concentration of EDTA in the sample.3.6.1.2 Precision for RepeatabilitySample preparation:A quantity of pulverized tablets equivalent to 300 mg of Calcium Lactate Pentahydrate was weighed and added into 250 conical flask. 50 ml of purified water was added and sonicated for 15 minutes. 80 ml of 0.01 M EDTA was transferred into conical flask. 8 ml of 5 M Sodium Hydroxide and exactly 0.01g of Solochrome Dark Blue Mixture were added into the conical flask.Note: Solochrome Dark Blue Mixture (Mixture of 0.1 g Solochrome Dark Blue and 0.9 g of ignited anhydrous Sodium Sulphate)Continue to titrate until the colour changes from purple to full blue. Record the total voulume of 0.01 M EDTA used. Note: Each ml of 0.01 M EDTA equivalent to 0.003082 g of Calcium Lactate Pentahydrate.

Where, V= Volume of EDTA used C= Actual concentration of Disodium Edetate Solution used Wspl= Weight of sample (Calcium Lactate Pentahydrate) 0.01= Concentration of EDTA solutionAcceptance Criteria: The RSD for 6 replicate Sample Preparations should not exceed 2.0%.3.7 Thin-Layer Chromatography (TLC)Thin-layer chromatography is a separation technique in which a stationary phase consisting of an appropriate material is spread in a uniform thin layer on a support (plate) of glass, metal or plastic. Solutions of analytes are deposited on the plate prior to development. The separation is based on adsorption, partition, ion-exchange or on combinations of these mechanisms and is carried out by migration (development) of solutes (solutions of analytes) in a solvent or a suitable mixture of solvents (mobile phase) through the thin-layer (stationary phase). 3.7.1 ApparatusPlates -The chromatography is carried out using pre-coated plates.Preconditioning of the plates - It may be necessary to wash the plates prior to separation. This can be done by migration of an appropriate solvent. The plates may also be impregnated by procedures such as development, immersion or spraying. At the time of use, the plates may be activated, if necessary, by heating in an oven at 120 C for 20 min. Chromatographic tank - A chromatographic tank with a flat bottom or twin trough, of inert, transparent material, of a size suitable for the plates used and provided with a tightly fitting lid is required. For horizontal development the tank is provided with a trough for the mobile phase and it additionally contains a device for directing the mobile phase to the stationary phase. Micropipettes, microsyringes, calibrated disposable capillaries or other application devices suitable for the proper application of the solutions. Fluorescence detection device to measure direct fluorescence or the inhibition of fluorescence. Visualisation reagents - Suitable devices are used for derivatisation to transfer to the plate reagents by spraying, immersion or exposure to vapour and, where applicable, to facilitate heating for visualisation of separated components. Documentation-A device may be used to provide documentation of the visualised chromatogram, for example a photograph or a computer file. 3.7.2 MethodSample application - Apply the prescribed volume of the solutions at a suitable distance from the lower edge and from the sides of the plate and on a line parallel to the lower edge; allow an interval of at least 10 mm (5 mm on high-performance plates) between the centres of circular spots and 5 mm (2 mm on high-performance plates) between the edges of bands. Apply the solutions in sufficiently small portions to obtain circular spots 2-5 mm in diameter (1-2 mm on high-performance plates) or bands 10-20 mm (5-10 mm on high-performance plates) by 1-2 mm. In a monograph, where both normal and high-performance plates may be used, the working conditions for high-performance plates are given in the brackets [ ] after those for normal plates. Vertical development - Line the walls of the chromatographic tank with filter paper. Pour into the chromatographic tank a sufficient quantity of the mobile phase for the size of the tank to give after impregnation of the filter paper a layer of appropriate depth related to the dimension of the plate to be used. For saturation of the chromatographic tank, replace the lid and allow to stand at 20-25 C for 1 h. Unless otherwise indicated in the monograph, the chromatographic separation is performed in a saturated tank. Apply the prescribed volume of solutions as described above. When the solvent has evaporated from the applied solutions, place the plate in the chromatographic tank, ensuring that the plate is as vertical as possible and that the spots or bands are above the surface of the mobile phase. Close the chromatographic tank, maintain it at 20-25 C and protect from sunlight. Remove the plate when the mobile phase has moved over the prescribed distance, measured between the points of application and the solvent front. Dry the plate and visualise the chromatograms as prescribed. For two-dimensional chromatography, dry the plates after the first development and carry out a second development in a direction perpendicular to that of the first development. Horizontal development - Apply the prescribed volume of the solutions as described above. When the solvent has evaporated from the applied solutions, introduce a sufficient quantity of the mobile phase into the trough of the chamber using a syringe or pipette, place the plate in the chamber after verifying that the latter is horizontal and connect the mobile phase direction device according to the manufacturer's instructions. If prescribed, develop the plate starting simultaneously at both ends. Close the chamber and maintain it at 20-25 C. Remove the plate when the mobile phase has moved over the distance prescribed in the monograph. Dry the plate and visualise the chromatograms as prescribed. For two-dimensional chromatography, dry the plates after the first development and carry out a second development in a direction perpendicular to that of the first development. 3.7.3 Visual estimationIdentification - The principal spot in the chromatogram obtained with the test solution is visually compared to the corresponding spot in the chromatogram obtained with the reference solution by comparing the colour, the size and the retention factor (Rf) of both spots. The retardation factor (RF) is defined as the ratio of the distance from the point of application to the centre of the spot and the distance travelled by the solvent front from the point of application. Verification of the separating power for identification - Normally the performance given by the suitability test is sufficient. Only in special cases an additional performance criterion is prescribed in the monograph. Related substances test - The secondary spot in the chromatogram obtained with the test solution is visually compared to either the corresponding spot in the chromatogram obtained with the reference solution containing the impurity or the spot in the chromatogram obtained with the reference solution prepared from a dilution of the test solution. Verification of the separating power - The requirements for the verification of the separating power are prescribed in the monographs concerned. Verification of the detecting power - The detecting power is satisfactory if a spot or band is clearly visible in the chromatogram obtained with the most dilute reference solution.3.7.4 Quantitative measurementThe requirements for resolution and separation are prescribed in the monographs concerned.Substances separated by thin-layer chromatography and responding to UV-Vis irradiation can be determined directly on the plate, using appropriate instrumentation. While moving the plate or the measuring device, examine the plate by measuring the reflectance of the incident light. Similarly, fluorescence may be measured using an appropriate optical system. Substances containing radionuclides can be quantified in 3 ways: either directly by moving the plate alongside a suitable counter or vice versa, by cutting the plates into strips and measuring the radioactivity on each individual strip using a suitable counter or by scraping off the stationary phase, dissolving it in a suitable scintillation cocktail and measuring the radioactivity using a liquid scintillation counter.3.7.5 ApparatusThe apparatus for direct measurement on the plate consists of: a device for exact positioning and reproducible dispensing of the amount of substances onto the plate; a mechanical device to move the plate or the measuring device along the x-axis or the y-axis; a recorder and a suitable integrator or a computer; for substances responding to UV-Vis irradiation: a photometer with a source of light, an optical device able to generate monochromatic light and a photo cell of adequate sensitivity are used for the measurement of reflectance or transmittance; if fluorescence is measured, a suitable filter is required to prevent light used for excitation from reaching the detector while permitting emitted light or a specific portion thereof to pass; for substances containing radionuclides: a suitable counter for radioactivity. The linearity range of the counting device is to be verified. Method - Prepare the solution of the substance to be examined (test solution) as prescribed in the monograph and, if necessary, prepare the reference solutions of the substance to be determined using the same solvent as in the test solution. Apply the same volume of each solution to the plate and develop. Substances responding to UV-Vis irradiation - Prepare and apply not fewer than 3 reference solutions of the substance to be examined, the concentrations of which span the expected value in the test solution (about 80 per cent, 100 per cent and 120 per cent). Treat with the prescribed reagent, if necessary, and record the reflectance, the transmittance or fluorescence in the chromatograms obtained with the test and reference solutions. Use the measured results for the calculation of the amount of substance in the test solution. Substances containing radionuclides - Prepare and apply a test solution containing about 100 per cent of the expected value. Determine the radioactivity as a function of the path length and report the radioactivity in each resulting peak as a percentage of the total amount of radioactivity. 3.7.6 Additional pointsWhen the method prescribed in a monograph carries the instructions 'protected from light' or 'in subdued light' it is intended that the entire procedure is carried out under these conditions.Unless otherwise indicated in the monograph, the mobile phase should be allowed to ascend 15 cm above the line of application. The phrase ultraviolet light (254 nm) indicates that the plate should be examined under an ultraviolet lamp having a maximum output at 254 nm (see below); other wavelength maxima may be specified. The term secondary spot means any spot other than the principal spot. Similarly, a secondary band is any band other than the principal band. Where a spraying technique is prescribed it is essential that the reagent is evenly applied as a fine spray. The following method of visualisation is used when directed in the monograph.3.7.7 Related Substance of Hosolvon Tablet (BP 2014)This test is to determine any secondary spot in the chromatogram obtained with solution R1 is not more intense than the spot in the chromatogram obtained with Solution R2.TLC Plate:Plate coated with silica gel GMobile Phase:Heptane : Absolute Ethanol (95 : 5)Spray Reagent:0.5 g of N-(1-naphthyl)ethylenediamine Dihydrochloride was weighed and added into a 100 ml volumetric flask and make up to volume with Methanol.Test Solution:-Solution R1:A quantity of the powdered tablets containing 50 mg of Bromohexine Hydrochloride was shook with 5 ml of Methanol for 5 minutes, centrifuged for 5 minutes and use the supernatant liquid.Solution R2:1 ml of Solution R1 was diluted to 400 ml volumetric flask and make up to volume with Methanol.Procedure:20 l of solutions R1 and R2 was applied separately to plate. After removal of the plate, allow it to be dried in a current of warm air. The plate was placed in a tank containing a freshly prepared mixture of 1 g of Sodium Nitrite and 10 ml of 5 M Hydrochloric Acid and it was allowed to stand for 1 minute. The plate was removed and immediately sprayed with Spray Reagent. Observe the spots obtained. 3.8 Atomic Absorption Spectrometry (AAS)Atomic absorption is a process that occurs when a ground state-atom absorbs electromagnetic radiation of a specific wavelength and is elevated to an excited state. The atoms in the ground state absorb energy at their resonant frequency and the electromagnetic radiation is attenuated due to resonance absorption. The energy absorption is virtually a direct function of the number of atoms present. This chapter provides general information and defines the procedures used in element determinations by atomic absorption spectrometry, either atomisation by flame, by electrothermal vaporisation in a graphite furnace, by hydride generation or by cold vapour technique for mercury. Atomic absorption spectrometry is a technique for determining the concentration of an element in a sample by measuring the absorption of electromagnetic radiation by the atomic vapour of the element generated from the sample. The determination is carried out at the wavelength of one of the absorption (resonance) lines of the element concerned. The amount of radiation absorbed is, according to the Lambert- Beer law, proportional to the element concentration. 3.8.1 ApparatusThis consists essentially of: a source of radiation; a sample introduction device; a sample atomiser; a monochromator or polychromator; a detector; a data-acquisition unit. The apparatus is usually equipped with a background correction system. Hollow- cathode lamps and electrodeless discharge lamps (EDL) are used as radiation source. The emission of such lamps consists of a spectrum showing very narrow lines with half-width of about 0.002 nm of the element being determined. There are 3 types of sample atomisers: Flame technique - A flame atomiser is composed of a nebulisation system with a pneumatic aerosol production accessory, a gas-flow regulation and a burner. Fuel-oxidant mixtures are commonly used to produce a range of temperatures from about 2000 K to 3000 K. Fuel gases include propane, hydrogen and acetylene; air and nitrous oxide are used as oxidants. The configuration of the burner is adapted to the gases used and the gas flow is adjustable. Samples are nebulised, acidified water being the solvent of choice for preparing test and reference solutions. Organic solvents may also be used if precautions are taken to ensure that the solvent does not interfere with the stability of the flame. Electrothermal atomisation technique - An electrothermal atomiser is generally composed of a graphite tube furnace and an electric power source. Electrothermal atomisation in a graphite tube furnace atomises the entire sample and retains the atomic vapour in the light path for an extended period. This improves the detection limit. Samples, liquid as well as solid, are introduced directly into the graphite tube furnace, which is heated in a programmed series of steps to dry the sample and remove major matrix components by pyrolysis and to then atomise all of the analyte. The furnace is cleaned using a final temperature higher than the atomisation temperature. The flow of an inert gas during the pyrolysis step in the graphite tube furnace allows a better performance of the subsequent atomisation process. Cold vapour and hydride technique - The atomic vapour may also be generated outside the spectrometer. This is notably the case for the cold-vapour method for mercury or for certain hydride-forming elements such as arsenic, antimony, bismuth, selenium and tin. For mercury, atoms are generated by chemical reduction with stannous chloride or sodium borohydride and the atomic vapour is swept by a stream of an inert gas into a cold quartz cell mounted in the optical path of the instrument. Hydrides thus generated are swept by an inert gas into a heated cell in which they are dissociated into atoms. 3.8.2 Interferences Chemical, physical, ionisation and spectral interferences are encountered in atomic absorption measurements. Chemical interference is compensated by addition of matrix modifiers, of releasing agents or by using high temperature produced by a nitrous oxide-acetylene flame; the use of specific ionisation buffers (for example, lanthanum and caesium) compensates for ionisation interference; by dilution of the sample, through the method of standard additions or by matrix matching, physical interference due to high salt content or viscosity is eliminated. Spectral interference results from the overlapping of resonance lines and can be avoided by using a different resonance line. The use of Zeeman background correction also compensates for spectral interference and interferences from molecular absorption, especially when using the electrothermal atomisation technique. The use of multi-element hollow-cathode lamps may also cause spectral interference. Specific or non-specific absorption is measured in a spectral range defined by the band-width selected by the monochromator (0.2-2 nm). 3.8.3 Background correction Scatter and background in the flame or the electrothermal atomisation technique increase the measured absorbance values. Background absorption covers a large range of wavelengths, whereas atomic absorption takes place in a very narrow wavelength range of about 0.005-0.02 nm. Background absorption can in principle be corrected by using a blank solution of exactly the same composition as the sample, but without the specific element to be determined, although this method is frequently impracticable. With the electrothermal atomisation technique the pyrolysis temperature is to be optimised to eliminate the matrix decomposition products causing background absorption. Background correction can also be made by using 2 different light sources, the hollow-cathode lamp that measures the total absorption (element + background) and a deuterium lamp with a continuum emission from which the background absorption is measured. Background is corrected by subtracting the deuterium lamp signal from the hollow-cathode lamp signal. This method is limited in the spectral range on account of the spectra emitted by a deuterium lamp from 190-400 nm. Background can also be measured by taking readings at a non-absorbing line near the resonance line and then subtracting the results from the measurement at the resonance line. Another method for the correction of background absorption is the Zeeman effect (based on the Zeeman splitting of the absorption line in a magnetic field). This is particularly useful when the background absorption shows fine structure. It permits an efficient background correction in the range of 185-900 nm. 3.8.4 Choice of the operating conditions After selecting the suitable wavelength and slit width for the specific element, the need for the following has to be ascertained: correction for non-specific background absorption, chemical modifiers or ionisation buffers to be added to the sample as well as to blank and reference solutions, dilution of the sample to minimise, for example, physical interferences, details of the temperature programme, preheating, drying, pyrolysis, atomisation, post-atomisation with ramp and hold times, inert gas flow, matrix modifiers for electrothermal atomisation (furnace), chemical reducing reagents for measurements of mercury or other hydride-forming elements along with cold vapour cell or heating cell temperature, specification of furnace design (tank, L'vov platform, etc). 3.8.5 MethodUse of plastic labware is recommended wherever possible. The preparation of the sample may require a dissolution, a digestion (mostly microwave-assisted), an ignition step or a combination thereof in order to clear up the sample matrix and/or to remove carbon-containing material. If operating in an open system, the ignition temperature should not exceed 600 C, due to the volatility of some metals, unless otherwise stated in the monograph.Operate an atomic absorption spectrometer in accordance with the manufacturer's instructions at the prescribed wavelength. Introduce a blank solution into the atomic generator and adjust the instrument reading so that it indicates maximum transmission. The blank value may be determined by using solvent to zero the apparatus. Introduce the most concentrated reference solution and adjust the sensitivity to obtain a maximum absorbance reading. Rinse in order to avoid contamination and memory effects. After completing the analysis, rinse with water R or acidified water. If a solid sampling technique is applied, full details of the procedure are provided in the monograph. Ensure that the concentrations to be determined fall preferably within the linear part of the calibration curve. If this is not possible, the calibration plots may also be curved and are then to be applied with appropriate calibration software. Determinations are made by comparison with reference solutions with known concentrations of the element to be determined either by the method of direct calibration (Method I) or the method of standard additions (Method II). Method I - Direct Calibration: For routine measurements 3 reference solutions and a blank solution are prepared and examined. Prepare the solution of the substance to be examined (test solution) as prescribed in the monograph. Prepare not fewer than 3 reference solutions of the element to be determined, the concentrations of which span the expected value in the test solution. For assay purposes, optimal calibration levels are between 0.7 and 1.3 times the expected content of the element to be determined or the limit prescribed in the monograph. For purity determination, calibration levels are the limit of detection and 1.2 times the limit specified for the element to be determined. Any reagents used in the preparation of the test solution are added to the reference and blank solutions at the same concentration. Introduce each of the solutions into the instrument using the same number of replicates for each of the solutions to obtain a steady reading. Calculation - Prepare a calibration curve from the mean of the readings obtained with the reference solutions by plotting the means as a function of concentration. Determine the concentration of the element in the test solution from the curve obtained. Method II - Standard Additions: Add to at least 3 similar volumetric flasks equal volumes of the solution of the substance to be examined (test solution) prepared as prescribed. Add to all but 1 of the flasks progressively larger volumes of a reference solution containing a known concentration of the element to be determined to produce a series of solutions containing steadily increasing concentrations of that element known to give responses in the linear part of the curve, if possible. Dilute the contents of each flask to volume with solvent. Introduce each of the solutions into the instrument, using the same number of replicates for each of the solutions, to obtain a steady reading. Calculation - Calculate the linear equation of the graph using a least-squares fit and derive from it the concentration of the element to be determined in the test solution. 3.8.6 Validation of the method Satisfactory performance of methods prescribed in monographs is verified at suitable time intervals. Linearity:Prepare and analyse not fewer than 4 reference solutions over the calibration range and a blank solution. Perform not fewer than 5 replicates. The calibration curve is calculated by least-square regression from all measured data. The regression curve, the means, the measured data and the confidence interval of the calibration curve are plotted. The operating method is valid when: the correlation coefficient is at least 0.99, the residuals of each calibration level are randomly distributed around the calibration curve. Calculate the mean and relative standard deviation for the lowest and highest calibration level. When the ratio of the estimated standard deviation of the lowest and the highest calibration level is less than 0.5 or greater than 2.0, a more precise estimation of the calibration curve may be obtained using weighted linear regression. Both linear and quadratic weighting functions are applied to the data to find the most appropriate weighting function to be employed. If the means compared to the calibration curve show a deviation from linearity, two-dimensional linear regression is used. Accuracy: Verify the accuracy preferably by using a certified reference material (CRM). Where this is not possible, perform a test for recovery. Recovery - For assay determinations a recovery of 90 per cent to 110 per cent is to be obtained. For other determinations, for example, for trace element determination the test is not valid if recovery is outside of the range 80 per cent to 120 per cent at the theoretical value. Recovery may be determined on a suitable reference solution (matrix solution) which is spiked with a known quantity of analyte (middle concentration of the calibration range).Repeatability:The repeatability is not greater than 3 per cent for an assay and not greater than 5 per cent for an impurity test. Limit of quantification: Verify that the limit of quantification (for example, determined using the 10 approach) is below the value to be measured.3.8.7 Sensitivity of Heavy Metals Content (Pb)This is to determine the Sensitivity of Standard Preparation and QC Check of Lead to companys AAS machine.Diluent:10 ml of 30% v/v Hydrogen Peroxide and 40 ml of Concentrated Nitric Acid was added into a 1000 ml volumetric flask containing 500 ml purified water, make up to volume with purified water.Matrix Modifier:1 ml of Paladium and 0.6 ml Magnesium Nitrate was pipetted into a 10 ml volumetric flask. Then, it was sonicated and make up to volume with purified water.Standard Preparation for Lead:0.5 ml of Lead 1000 ppm Stock Solution was transferred into a 50 ml volumetric flask and make up to volume with purified water. It was labelled as 10 ppm Lead Standard Solution. 0.5 ml of the resulting solution was pipetted into a 100 ml volumetric flask and make up to volume with purified water. It was labelled as 50 ppb Lead Standard Solution. QC Check for Lead, 50 ppb:0.5 ml of Lead 1000 ppm Stock solution was transferred into a 50 ml volumetric flask and make up to volume with purified water. It was labelled as 10 ppm Lead Standard Solution. 0.5 ml of the resulting solution was pipetted into a 100 ml volumetric flask and make up to volume with purified water. It was labelled as 50 ppb Lead Standard Solution.Acceptance criteria for Sensitivity of Standard Preparation and QC Check: 30.0 pg for 50 g/LI was taught by Din, Lab Assistant to run AAS.3.9 Ultra Violet and Visible Spectrophotometry (UV-Vis)Determination of absorbance. The absorbance (A) of a solution is defined as the logarithm to base 10 of the reciprocal of the transmittance (T) for monochromatic radiation :

T = I/ I0,I0 = intensity of incident monochromatic radiation,I = intensity of transmitted monochromatic radiation.In the absence of other physico-chemical factors, the measured absorbance (A) is proportional to the path length (b) through which the radiation passes and to the concentration (c) of the substance in solution in accordance with the equation:

= molar absorptivity, if b is expressed in centimetres and c in moles per litre.Limit of stray light - Stray light may be detected at a given wavelength with suitable filters or solutions: for example, the absorbance of a 12 g/l solution of potassium chloride R in a 1 cm cell increases steeply between 220 nm and 200 nm and is greater than 2.0 at 198 nm when compared with water as compensation liquid. Suitable certified reference materials may also be used. Resolution (for qualitative analysis) - When prescribed in a monograph, measure the resolution of the apparatus as follows: record the spectrum of a 0.02 per cent V/V solution of toluene R in hexane R. The minimum ratio of the absorbance at the maximum at 269 nm to that at the minimum at 266 nm is stated in the monograph. Suitable certified reference materials may also be used. Spectral slit-width (for quantitative analysis) - To avoid errors due to spectral slit-width, when using an instrument on which the slit-width is variable at the selected wavelength, the slit-width must be small compared with the half-width of the absorption band but it must be as large as possible to obtain a high value of I0. Therefore, a slit-width is chosen such that further reduction does not result in a change in absorbance reading. Cells - The tolerance on the path length of the cells used is 0.005 cm. When filled with the same solvent, the cells intended to contain the solution to be examined and the compensation liquid must have the same transmittance. If this is not the case, an appropriate correction must be applied. The cells must be cleaned and handled with care.3.9.1 Linearity of Lipiduce 20 Tablet (IH)This test is to determine the linearity for standard in a series of different concentration.Dissolution Medium, 0.05 M Phosphate Buffer, pH 6.8:13.6 g of Potassium Dihydrogen Orthophosphate was dissolved in 1500 ml of Purified water. The pH of the Dissolution Medium was checked and adjusted pH to 6.8 with 1 M Sodium Hydroxide. 500 ml of Purified water was added into the Dissolution Medium.Standard Preparation0.023 g of Atorvastation working standard was weighed and added into 100 ml of volumetric flask, then it was dissolved with 5 ml of Methanol and make up to volume with Dissolution medium. (0.22 mg/ ml)Procedure:A series of 50%, 80%, 100%, 120% and 150% of different concentration of new standard solution was diluted from the 0.22 mg/ ml of Standard Solution. 2.5 ml (50%), 4 ml (80%), 5 ml (100%), 6 ml (120%) and 7.5 ml (150%) was pipetted into 100 ml volumetric flask and make up to volume with Dissolution medium. Then, all of the 5 new standard solutions was scanned with UV-Vis spectrophotometry. Plot a linearity graph by using Microsoft Excel, the acceptance criteria R2 is 0.9990 and above.3.9.2 Assay Vitamin A of Seven Seas Cod Liver Oil Gold Capsule (IH-UV-471)This test is to determine the assay in the sample lies in the specification required. The specification is not less than 540 IU/ capsule of Vitamin A is obtained.Procedure:5 capsules was cut and the content was poured into a beaker. 0.324 g of the content was weighed into a 100 ml round bottom flask. 30 ml of Absolute Ethanol, 3 ml of freshly prepared 50% w/w solution of Potasium Hydroxide and a few Anti-Bumping Granuless were added. The content was boiled under a reflux condenser on a water bath for 30 minutes. Th content was cooled rapidly by adding 30 ml of Purified Water and transferred the content into a separating funnel. The flask was washed carefully with 50 ml of Ether and poured into the separating funnel for three times. The separating funnel was shook for 1 minutes and then allowed to stand until two layers are clear. The bottom layer was discarded. The resulting separated extract was extracted with 4 quantities of 50 ml Purified Water. Mixing very cautiously during the first 2 extractions to avoid the formation of emulsion. The separated extract was evaporated to about 5 ml with current of Oxygen-free Nitrogen. The residue was dissolved in sufficient Propan-2-ol to produce 50 ml. Then, it was further diluted to 250 ml volumetric flask. With low speed, scan the UV wavelength from 250 nm to 400 nm by using Propan-2-ol as blank. The maximum wavelength should lie between 323 to 327 nm. The point of absorbance was picked at 300, 310, 325 and 334 nm. Calculation for assay was calculated.

3.10 High Performance Liquid Chromatography (HPLC)3.10.1 Limit of Detection (LOD)/ Limit of Quantitation (LOQ) for Clofenac 50It is to detect the range of detection of HPLC for Clofenca 50, so that we can use the minimum of sample, working standard and CRM to run our testing, this will help company to save cost.Diluent:1000 ml of diluent (Methanol : Purified water : 7 : 3) was prepared.Specificity:-It is to determine the different between active ingredient and base without active ingredient in HPLC, so that we can know the duration of time to run the HPLC for particular active ingredient and the different in chromatography between active ingredient and base without active ingredient in HPLC, this will help the lab assistant the estimate the time required to run the HPLC and help the chemist to detect the chromatography of the active ingredient.Standard Preparation:0.075g of Diclofenac Sodium working standard (IRM) was weighed and added into 100 ml volumetric flask, make up to volume with diluent. Filtered with 0.20 m PVDF membrane filter.Base Preparation:Base without Diclofenac Sodium equivalent to CW was weighed and added into 100 ml volumetric flask, added 70 ml diluent and shaked for 30 minutes. Let it cooled to room temperature. Then, make up to volume with diluent. Filtered with 0.20 m PVDF membrane filter.LOD/ LOQ:-A series of dilutions for Diclofenac Sodium working standard (IRM) and Diclofenac Related A (CRM) were prepared.Diclofenac Sodium working standard:0.5 Dilution factor was used for 14 times to prepare total 15 different concentration of Diclofenac Sodium working standard. Diclofenac Related A:0.5 Dilution factor was used for 10 times to prepare total 11 different concentration of Diclofenac Related A.Run HPLC by Aziz, Lab Assistant.3.10.2 Precision Determination of Assay & Preservative Content for Ducodin Forte Linctus 15 mg/ 5 ml (Methyl Paraben, Propyl Paraben - IH-HPLC-268) (Pholcodine IH-HPLC-267)This test is to determine the precision for 6 samples which was prepared by same lab assistant, so we can determine the procedure is valid to be used. The specification is as below: 85.0% to 120.0 % of the labeled amount of Methyl Paraben and Propyl Paraben, 13.50 mg to 16.50 mg of Pholcodine per 5 ml, by HPLC. The Tailing Factor of the peak corresponding to Pholcodine is not more than 3.0 and RSD for replicate injections is not more than 3.0%. The Tailing Factor of the peaks corresponding to Methyl Paraben and Propyl Paraben is not more than 2.0 and RSD for replicate injections is not more than 3.0%.Standard Preparation:0.05625 g of Methyl Paraben, 0.00625 g of Propyl Paraben and 0.09799 g of Phocodine working standard (equivalent to 0.09375 g of anhydrous phocodine) were weighed into a 50 ml volumetric flask with the aid of minimal amount of Purified Water. Then, It was dissolved with 4 ml of Methanol and make up to volume with Purified Water. Next, 4 ml resulting solution was pipetted into a 10 ml volumetric flask and make up to volume with Purified Water. The solution was filtered with 0.45 m PTFE membrane filter, discarded the first 5 ml.Sample Preparation:A quantity of the sample equivalent to 15 mg of Pholcodine was weighed into a 20 ml volumetric flask. 2 ml of Methanol was added to dissolve the sample and make up to volume with Purified Water. The solution was filtered with 0.45 m PTFE membrane filter, discarded the first 5 ml of the filtrate. The clear filtrate was used as Sample Preparation. Repeat this procedure for 6 samples.Mobile Phase:4.3254 g of Sodium Octanesulphonate Salt was dissolved with 500 ml of Purified Water. 500 ml of Methanol and 2 ml of Glacial Acetic Acid were added and mixed well.Chromatographic Conditions:Column: RP- 18 (150 mm x 4.6 mm, 5 m) Brand ZorbaxDetector: PDA, UV 285 nmFlow Rate: 1.00 ml/ minVolume: 20 l3.11 Fourier Transform Infrared (FTIR)Infrared spectrophotometers are used for recording spectra in the region of 4000-650 cm-1 (2.5-15.4 m) or in some cases down to 200 cm-1 (50 m). 3.11.1 Apparatus Spectrophotometers for recording spectra consist of a suitable light source, monochromator or interferometer and detector. Fourier transform spectrophotometers use polychromatic radiation and calculate the spectrum in the frequency domain from the original data by Fourier transformation. Spectrophotometers fitted with an optical system capable of producing monochromatic radiation in the measurement region may also be used. Normally the spectrum is given as a function of transmittance, the quotient of the intensity of the transmitted radiation and the incident radiation. It may also be given in absorbance. The absorbance (A) is defined as the logarithm to base 10 of the reciprocal of the transmittance (T):

T = I/ I0,I0 = intensity of incident radiation,I = intensity of transmitted radiation.3.11.2 Preparation of the sample For recording by transmission or absorption Prepare the substance by one of the following methods. Liquids - Examine a liquid either in the form of a film between 2 plates transparent to infrared radiation, or in a cell of suitable path length, also transparent to infrared radiation.Liquids or solids in solution - Prepare a solution in a suitable solvent. Choose a concentration and a path length of the cell which give a satisfactory spectrum. Generally, good results are obtained with concentrations of 10-100 g/l for a path length of 0.5-0.1 mm. Absorption due to the solvent is compensated by placing in the reference beam a similar cell containing the solvent used. If an FT-IR instrument is used, the absorption is compensated by recording the spectra for the solvent and the sample successively. The solvent absorbance, corrected by a compensation factor, is subtracted using calculation software. Solids - Examine solids dispersed in a suitable liquid (mull) or in a solid (halide disc), as appropriate. If prescribed in the monograph, make a film of a molten mass between 2 plates transparent to infrared radiation. A. Mull Triturate a small quantity of the substance to be examined with the minimum quantity of liquid paraffin R or other suitable liquid; 5-10 mg of the substance to be examined is usually sufficient to make an adequate mull using one drop of liquid paraffin R. Compress the mull between 2 plates transparent to infrared radiation. B. Disc Triturate 1-2 mg of the substance to be examined with 300-400 mg, unless otherwise specified, of finely powdered and dried potassium bromide R or potassium chloride R. These quantities are usually sufficient to give a disc of 10-15 mm diameter and a spectrum of suitable intensity. If the substance is a hydrochloride, it is recommended to use potassium chloride R. Carefully grind the mixture, spread it uniformly in a suitable die, and submit it to a pressure of about 800 MPa (8 tcm-2). For substances that are unstable under normal atmospheric conditions or are hygroscopic, the disc is pressed in vacuo. Several factors may cause the formation of faulty discs, such as insufficient or excessive grinding, humidity or other impurities in the dispersion medium or an insufficient reduction of particle size. A disc is rejected if visual examination shows lack of uniform transparency or when transmittance at about 2000 cm-1 (5 m) in the absence of a specific absorption band is less than 60 per cent without compensation, unless otherwise prescribed. Gases - Examine gases in a cell transparent to infrared radiation and having an optical path length of about 100 mm. Evacuate the cell and fill to the desired pressure through a stopcock or needle valve using a suitable gas transfer line between the cell and the container of the gas to be examined. If necessary adjust the pressure in the cell to atmospheric pressure using a gas transparent to infrared radiation (for example nitrogen R and argon R). To avoid absorption interferences due to water, carbon dioxide or other atmospheric gases, place in the reference beam, if possible, an identical cell that is either evacuated or filled with the gas transparent to infrared radiation. For recording by diffuse reflectance Solids - Triturate a mixture of the substance to be examined with finely powdered and dried potassium bromide R or potassium chloride R. Use a mixture containing approximately 5 per cent of the substance, unless otherwise specified. Grind the mixture, place it in a sample cup and examine the reflectance spectrum. The spectrum of the sample in absorbance mode may be obtained after mathematical treatment of the spectra by the Kubelka-Munk function. For recording by attenuated total reflection Attenuated total reflection (including multiple reflection) involves light being reflected internally by a transmitting medium, typically for a number of reflections. However, several accessories exist where only one reflection occurs. Prepare the substance as follows. Place the substance to be examined in close contact with an internal reflection element (IRE) such as diamond, germanium, zinc selenide, thallium bromide-thallium iodide (KRS-5) or another suitable material of high refractive index. Ensure close and uniform contact between the substance and the whole crystal surface of the internal reflection element, either by applying pressure or by dissolving the substance in an appropriate solvent, then covering the IRE with the obtained solution and evaporating to dryness. Examine the attenuated total reflectance (ATR) spectrum. 3.11.3 Identification using reference substances Prepare the substance to be examined and the reference substance by the same procedure and record the spectra between 4000-650 cm-1 (2.5-15.4 m) under the same operational conditions. The transmission minima (absorption maxima) in the spectrum obtained with the substance to be examined correspond in position and relative size to those in the spectrum obtained with the reference substance (CRS). When the spectra recorded in the solid state show differences in the positions of the transmission minima (absorption maxima), treat the substance to be examined and the reference substance in the same manner so that they crystallise or are produced in the same form, or proceed as prescribed in the monograph, then record the spectra. 3.11.4 Identification using reference spectra Control of resolution performance - For instruments having a monochromator, record the spectrum of a polystyrene film approximately 35 m in thickness. The difference x (see Figure 3.11.1) between the percentage transmittance at the transmission maximum A at 2870 cm-1 (3.48 m) and that at the transmission minimum B at 2849.5 cm-1 (3.51 m) must be greater than 18. The difference y between the percentage transmittance at the transmission maximum C at 1589 cm-1 (6.29 m) and that at the transmission minimum D at 1583 cm-1 (6.32 m) must be greater than 10. For Fourier-transform instruments, use suitable instrument resolution with the appropriate apodisation prescribed by the manufacturer. The resolution is checked by suitable means, for example by recording the spectrum of a polystyrene film approximately 35 m in thickness. The difference between the absorbances at the absorption minimum at 2870 cm-1 and the absorption maximum at 2849.5 cm-1 is greater than 0.33. The difference between the absorbances at the absorption minimum at 1589 cm-1 and the absorption maximum at 1583 cm-1 is greater than 0.08.Figure 3.11.1 Typical spectrum of polystyrene used to verify the resolution performance.

Verification of the wave-number scale - The wave-number scale may be verified using a polystyrene film, which has transmission minima (absorption maxima) at the wave numbers (in cm1) shown in Table 3.11.1.Table 3.11.1 Transmission minima and acceptable tolerances of a polystyrene film.

Method - Prepare the substance to be examined according to the instructions accompanying the reference spectrum/reference substance. Using the operating conditions that were used to obtain the reference spectrum, which will usually be the same as those for verifying the resolution performance, record the spectrum of the substance to be examined. The positions and the relative sizes of the bands in the spectrum of the substance to be examined and the reference spectrum are concordant in the 2 spectra. Compensation for water vapour and atmospheric carbon dioxide - For Fourier-transform instruments, spectral interference from water vapour and carbon dioxide is compensated using suitable algorithms according to the manufacturer's instructions. Alternatively, spectra can be acquired using suitable purged instruments or ensuring that sample and background single beam spectra are acquired under exactly the same conditions. 3.11.5 Impurities in gases For the analysis of impurities, use a cell transparent to infrared radiation and of suitable optical path length (for example, 1-20 m). Fill the cell as prescribed under Gases. For detection and quantification of the impurities, proceed as prescribed in the monograph.3.11.6 Project of Identification of Montelukast Winthrop 10 Tablet (BP 2014)This project is to develope a new protocol for Identification of Montelukast Winthrop 10 Tablet by using FTIR with reference to BP 2014. First of all, we dissolved a quantity of tablet powder which has been grinded become powder, in 15 ml of Ethanol. Then, it was sonicated for 15 minutes and filtered by using Whaltman No. 1 filter paper. The filtrate was dried with N2 gas flow. It was using the recystallization method to get the residue of the active ingredient. The residue was tested by using FTIR. This method can not get 0.95 and above for the FTIR. Then, we try with other solvent. We have try Chloroform, Dichloromethane, Methanol, Acetone and Tetrahydrofuran, but we still can not get 95% and above. After that, my supervisor suggested to use two different solvents to extract out the active ingredient. First of all, we dissolved a quantity of tablet powder which has been grinded become powder, in 15 ml of Ethanol. Then, it was sonicated for 15 minutes and filtered by using Whaltman No. 1 filter paper. The filtrate was dried with N2 gas flow. It was using the recystallization method to get the residue of the active ingredient. The residue was dissolved again in 15 ml of Tetrahydrofuran. Then, it was sonicated for 15 minutes and filtered by using Whaltman No. 1 filter paper. The filtrate was dried with N2 gas flow. It was again using the recystallization method to get the residue of the active ingredient. The residue was tested by using FTIR. This method still can not get 0.95 and above for the FTIR. Then, we try with other combination of solvent (Tetrahydrofuran followed by ethanol, Ethanol followed by Ethanol), but we can not get 95% and above.Then we find out that, our residue is remained with active ingredient Montelukast Sodium and also non active ingredient which is lactose. So, we dissolved a quantity of tablet powder which has been grinded become powder, in 15 ml of Ethanol. Then, it was sonicated for 15 minutes and filtered by using 0.20 m PTFE membrane syringe. The micro membrane syringe is help to filter the lactose from the active ingredient. The filtrate was dried with N2 gas flow. It was using the recystallization method to get the residue of the active ingredient. The residue was tested by using FTIR. Finally, we get 0.95 by using FTIR. This project took three weeks to develope a new protocol procedure with reference to BP 2014.

CHAPTER 4CONCLUSION

From the industrial training program within 12 weeks, I have gained many unvaluable knowledge experience in Hovid Bhd. Hovid Bhd. is an ideal company for students to undergo their industrial training program. The objectives of the industrial training are achieved.Within 12 weeks of practical training, I have learned more on hands on training. It including on sample preparation, standard and policies company, safety in laboratory, safety measure to handle equipments and so on. The working environment provided enable the staff to perform distinctively as they are willing to assist each other to solve problems. In addition, lots of experiences and knowledge are obtained such as my interpersonal skill is strengthened via effective communication and relationship with the co-workers. Having my industrial training in Hovid Bhd. gives me a great opportunity and advantage to realize the importance to maintain the quality of the products. The products manufactured are strictly examined and tested by Quality Control and Quality Assurance Department to provide products that can satisfy the customers need and to improve the effectiveness of the Quality Management System. In turn, the profitable relationship between the customer and the company can be achieved. When the customer satisfaction is fulfilled, the overall process of enhancing and maintaining profitable customer relationships, by delivering remarkable value and satisfaction, is obtained. Hence, customer lifetime value will be reached where the customer will consider for a lifetime of patronage.Last but not least, it was my honor to have the chance to work in Hovid Bhd. I truly enjoy to be trained at Hovid Bhd. and appreciate their commitment and cooperation given to me.

CHAPTER 5PROBLEMS AND SUGGESTIONS

Based on my practical training for 12 weeks, I have occured several problems. The problems are as follows :1. The duration for practical training consists of this 12 weeks is not sufficient to get more valuable experience.2. Since we are student, if it is without any elaun, we are not able to cover our budget.3. Since we are trained in the lab, it is very dangerous when handling chemicals due to the laboratory coat design are not safety enough.4. There are no course outline or no specific format doing this practical training.Suggestively speaking, I humbly opine that some recommendations from my point of view about the industrial training : The period of the industrial training can be prolonged to 4 months as students can gain more experiences and knowledge. Yet, departmental shifting can also be easier for the company to arrange to the trainees with the prolonged period. Company should give some elaun, it will help a student a lot even it is RM300. The university should provide insurance for the trainees. Clearer industrial training guideline such as sample of report. Increase the coordination between university and the selected organization. Laboratory coat should be do some development in term of the design. The slieve should be close enough.

Referrences

Mr Tai Wen Xi, QC Chemist,Hovid Bhd.Mrs Choy Wai Peng, QC Manager,Hovid Bhd.Encik Johari Amran, Senior QC Excutive,Hovid Bhd.Dr. Roswanira Abdul Wahab,Jabatan Kimia, Faculty Science,UTM Skudai Malaysia.United State Pharmacopoeia 36British Pharmacopoeia 2014

AppendixesBelow are some pictures taken during my 12 weeks practical training. *Just for report purpose only. Strictly prohibited.Figure 1 : Environment in analytical lab Figure 2 : Chemicals and samples in laboratory Figure 3 : Weighing balance area Figure 4 : Friability test Figure 5 : Disintegration time test

Figure 6 : Dissolution test Figure 7 : FTIR test Figure 8 : HPLC test

Figure 9 : AAS test

Figure 10 : GC test Figure 11 : UV-Vis test

Figure 12 : Reflux area Figure 13 : Optical rotation test

Figure 14 : Vortex, sonicate and centrifuge area Figure 15: Safety and health Figure 16 : pH meter test

Figure 17 : Ultra-violet light

Figure 18 : Oven

Figure 19 : Purified water area

Figure 20 : Vacuum pump area