m. pharmacy i –sem. (cbcs) (common to all) …gprcp.ac.in/qpmp/2016/all paqa1 all.pdfou - 1701 ou...

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Code No: 13110/CBCS

FACULTY OF PHARMACYM. Pharmacy I –Sem. (CBCS) (Common to all) (Backlog) Examination, August 2019

Subject: Pharmaceutical Analytical TechniquesTime: 3 Hours Max.Marks:75

Note: Answer any five questions. All questions carry equal marks

1. (a) Explain the concept of chromophore and auxo-chrome with examples. 6(b) Describe different quantitative methods used for quantitative analysis of multi

component samples. 9

2. (a) Give the principle and theory involved in FTIR spectroscopy. 7(b) Explain different sample handling techniques for IR spectroscopy. 8

3. Write about the following 3x5=15(a) Shielding and de shielding(b) Chemical shift(c) Spin-Spin coupling

4. (a) Describe the Principle and working of Mass spectrometer with a neat labeleddiagram. 9

(b) Explain about different fragmentation rules and patterns with respect to variousfunctional groups. 6

5. Write about the following 2 x 7 ½ = 15(a) Derivatisation techniques in GC(b) Chiral chromatography

6. (a) Explain the principle and procedure involved in a radioimmunoassay with anexample. 8

(b) Describe capillary electrophoresis technique along with separation principles. 7

7. (a) Discuss the principles of DTA and DSC techniques. 8(b) Explain the thermo gram of polymers. 7

8. (a) Give the principles of X-Ray diffraction methods. 4(b) Explain Bragg’s equation and Miller indices. 5(c) Describe rotating crystal technique for X-ray diffraction studies. 6

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Code No. 13123 / CBCSFACULTY OF PHARMACY

M. Pharmacy (P.A & Q.A) I – Semester (CBCS) (Backlog) Examination, Aug. 2019Subject: Instrumental Methods of Analysis

Time: 3 Hours Max.Marks: 75Note: Answer any five questions. All questions carry equal marks.

1 Explain the working principles and applications of the following techniques 2x71/2=15i) Confocal microscopyii) Transmission electron microscopy

2 a) Describe different techniques used for measurement of pH. 7

b) Explain different types of conductimetric titrations and advantages over titrimetricmethods. 8

3 Write about the principle, instrumentation working and applications of flamephotometry. 15 6

4 Describe the different techniques used for in particle size analysis. 15

5 Write the IP methods for determination of the following physical parameters. 3x5=15i) Dissolution Testii) Limit testsiii) Melting range

6 Explain the phenomena of fluorescence and phosphorescence and discuss aboutdifferent factors affecting the fluorescence and phosphorescence phenomena. 9Write about amperometric titrations. 6

7 Explain the principles of microbial assays and pharmacopoeial methods for evaluation ofAntimicrobial activity of antibiotics. 15 7

8 Explain about different sample preparation techniques used for sample preparation ofTissue extracts for analysis. 10Write the principles and applications of GC-MS technique. 5

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Code No: 13118/CBCSFACULTY OF PHARMACY

M. Pharmacy (Pharmaceutics & P.A. & Q.A.) I-semester (Backlog) (CBCS)Examination, August 2019

Subject: Quality AssuranceTime: 3hrs Max Marks: 75

Note: Answer any five questions, all questions carry equal marks

1. a) Define Quality Control and Quality Assurance? Describe Quality Assurance of airhandling systems?

b) Explain Quality Assurance of aseptic process control.

2. a) Describe IPQC tests for suspensions and emulsions?b) What are the problems encountered during tablet production?

3. a) What is the significance of ISO implementation for an organization? Describe Qualityconcepts of ISO?

b) Explain certification procedure of ISO9000 series?

4. a) Define audit? Classify audit systems?b) Explain in detail different types of audit?

5. a) What are essential qualities and responsibilities of analyst?b) Describe operation systems and procedures in QC Lab?

6. a) What do you mean by good documentation practice? Describe Root cause analysis?b) Classify pharmaceutical impurities according to WHO?

7. a) How pharmaceutical impurities are isolated and characterized?b) Explain concept of purity angle?

8. a) Compare the policies, general presentation of monographs and other differencesbetween IP, BP, USP?(b) Write a short note on ISO 4000?

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M. Pharmacy (P.A & Q.A) I – Semester (CBCS) (Backlog) Examination, Aug. 2019Subject: Instrumental Methods of Analysis


1 Explain the working principles and applications of the following techniques 2x71/2=15i) Confocal microscopyii) Transmission electron microscopy

2 a) Describe different techniques used for measurement of pH. 7

b) Explain different types of conductimetric titrations and advantages over titrimetricmethods. 8

3 Write about the principle, instrumentation working and applications of flamephotometry. 15 6

4 Describe the different techniques used for in particle size analysis. 15

5 Write the IP methods for determination of the following physical parameters. 3x5=15i) Dissolution Testii) Limit testsiii) Melting range

6 Explain the phenomena of fluorescence and phosphorescence and discuss aboutdifferent factors affecting the fluorescence and phosphorescence phenomena. 9Write about amperometric titrations. 6

7 Explain the principles of microbial assays and pharmacopoeial methods for evaluation ofAntimicrobial activity of antibiotics. 15 7

8 Explain about different sample preparation techniques used for sample preparation ofTissue extracts for analysis. 10Write the principles and applications of GC-MS technique. 5

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M. Pharmacy (P.A & Q.A) I – Semester (CBCS) (Backlog) Examination, Aug. 2019Subject: Quality Control of Health Related Products


1 Explain Quality control tests fora) Eye care products. (7)b) Baby care products. (8)

2 Write about the following.a) Quantitative microscopy. (8)b) Micro chemical tests. (7)

3 a) Describe the principle and procedure involved in the biological assay of Insulin. (7)b) Write the principle and procedure involved in bioassay of tetanus vaccine. (8)

4 a) Explain the principles in the assay of ascorbic acid by using 2, 6 dichlorophenolIndophenol and 3,4 di nitro benzoic acid. (5)

b) Write different methods for determination of quality control of vitamin B1 inneutraceuticals. (10)

5 a) List out the Quality control tests for Fats and oils. Explain the principle andmethod details for determination of acid value. (7)

b) Explain the determination of ash and mineral constituents in food constituents. (8)

6 a) Give analytical methods for determination of milk and milk products. (7)b) Give the details of kjeldahl method for determination of nitrogen and its

importance in Pharmaceuticals. (8)

7 a) Give any two methods for determination of Vitamin B12 in nutraceuticals. (7)b) Explain quality control tests for Baby care products. (8)

8 Discuss the biological assay of Oxytocin and rabies vaccines. (15)

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Code No: 1305/CBCS

FACULTY OF PHARMACYM. Pharmacy I Semester(CBCS) (Common to all) (Backlog) Examination,

July/August 2018

Subject: Pharmaceutical Analytical Techniques

Time: 3 Hours Max.Marks : 75

Note: Answer any five questions. All questions carry equal marks

1. (a) Draw a neat labeled diagram of double beam UV spectrometer. 8(b) Describe different quantitative methods for analysis of single component present

in organic compounds by UV spectroscopy. 72. (a) Explain in brief about interpretation of IR spectra of organic compounds. 10

(b) Explain different sample handling techniques for solids in IR spectroscopy 53. Write about the following

(a) Supercritical fluid chromatography 8(b) Applications of HPTLC technique 7

4. (a) Explain about shielding and deshielding effects. 6(b) Describe different types of detectors used in HPLC instruments. 9

5. (a)Describe the principle and procedure involved in ELISA technique with anexample. 8

(b) Give theory and principle involved in paper electrophoresis technique. 7

6. (a) What are thermal methods and their importance in analysis of pharmaceuticals? 7 ½(b) Make a note on X-Ray crystallography. 7 ½

7. Discuss the principles of DTA and DSC techniques, and write their applicationsalong with the interpretation of thermograms. 15

8. Explain about the following(a) Column efficiency parameters(b) Mobile phase selection(c) Column packing materials 3x5 = 15

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Code No. 1313/CBCS

FACULTY OF PHARMACYM. Pharmacy (Pharmaceutics/PA&QA) I-Semester (CBCS)(Backlog) Examination,

August 2018

Subject: Quality Assurance

Time: 3hours Max. Marks: 75

Note: Answer any five questions. All questions carry equal marks.

1. a. Define Quality control and quality assurance? Describe quality assurance of

buildings and facilities? 10

b. Explain change control procedures? 5

2. a. Describe IPQC tests for Tablets? 9

b. What are the problems encountered during the production of oral liquid products? 6

3. a. What is the significance of ISO implementation for an organization? Describe

guidelines and requirements of ISO? 9

b. Explain certification procedure of ISO14000 series? 6

4. Classify audit systems? Explain in detail various types of audits performed for a

pharmaceutical industry? 15

5. a. What do you mean by analytical worksheet? 5

b. Explain the safety guidelines to be followed in QC lab? 10

6. a. What do you mean by good documentation practice? Describe corrective and

preventive action (CAPA)? 8

b. Write a note on out of specification (OOS) and out of trend (OOT) 7

7. a. Explain concept of purity angle ? 10

b. Explain effect of impurities on drug stability and therapeutic action? 5

8. a. Compare the policies, general presentation of monographs and other differences

between IP,BP, USP? 10

b. Write a short note on ISO 9000? 5

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M. Pharmacy (Pharmaceutics / PA&QA)I – Semester (CBCS) (Backlog) Examination, August 2018

Subject: Pharmaceutical Product Development

Time: 3 Hours Max.Marks: 75

Note: Answer any five questions. All questions carry equal marks.1 a) Describe the role of Crystallinity & Polymorphism in preformualtion studies. 7M

b) Explain factorial design with an example. 8M

2 a) Write a note on excipients used in tablet dosage form with examples. 9Mb) How do you evaluate drug-excipient compatibility? Explain any two tests. 6M

3 a) How do you determine the solubility of a drug? 10Mb) Write a note on aqueous solubility aspects in pre-formulation studies. 5M

4 Describe the different factors influencing dissolution. 15M

5 a) Explain the dissolution apparatus for testing of conventional and controlledrelease products. 10M

b) Write a note on Bio-relevant media in dissolution. 5M

6 a) Describe the effect of Temperature and pH on stability of drugs. 10Mb) Write a note on shelf life determination. 5M

7 a) What do you understand by Hatch-Waxmann Act and Bolar Amendment. 8Mb) Write a note on generation & significance of nanopharmaceuticals. 7M

8 a) Write a note on co-processing of excipients. 7Mb) Write a note on ANDA approval process for generic drug. 8M

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M. Pharmacy (P.A & Q.A) I – Semester (CBCS) (Backlog) Examination,August 2018

Subject: Instrumental Methods of AnalysisTime: 3 Hours Max.Marks: 75


1. Explain the working principles and applications of the following techniques 2x71/2=14a) Atomic Force microscopyb) Scanning electron microscopy

2 a) Explain different end point evaluation methods for end point determination inpotentiometric titrations. 10

b) Explain Wheatstone bridge principle. 5

3 Explain the principle and theory involved in Raman spectroscopy. Give thedifferences between Raman and IR spectroscopy in application. 8Discuss about different factors affecting the fluorescence and phosphorescencephenomena. 7

4 Describe the different components of LC/MS technique and its applications inanalysis of biological samples. 15

5 Explain the IP methods for determination of the following physical parameters. 3x5Freezing pointDissolution testRefractive index

6 Discuss the theory and principles of atomic absorption spectroscopy. 8Describe different methods used for quantitative analysis of alkali metals byflame photometry technique. 7

7 Explain about different sample preparation techniques used for sample preparationof Phytochemical extracts for analysis. 9Give the significance of limit tests and how do you conduct limit test for Iron asper IP. 6

8 Discuss the principle, instrumentation, working and applications of flame photometry. 15

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M. Pharmacy (P.A & Q.A) I – Semester (CBCS) (Backlog) Examination,August 2018

Subject: Quality Control of Health Related ProductsTime: 3 Hours Max.Marks: 75

Note: Answer any five questions. All questions carry equal marks.1 Explain Quality control tests for

a) Shampoos for hair care. (7)b) Baby care products. (8)

2 How do you determine and check the quality of crude drugs for Ash content,extractive matter and haemolytic activity. (15)

3 Discuss the principle and method involved in bioassay of Oxytocin and insulin. (15)

4 a) Give any two methods for determination of Vitamin B12. (7)b) Give any two methods for determination of Vitamin B1. (8)

5 a) Write any two methods for determination of carbohydrates as food constituents. (8)b) Explain the Gerber method for analysis of fat in milk. (7)

6 Write about the following.a) Determination of Saponification value. (8)b) UV and fluorescence analysis of powdered drugs (7)

7 Discuss the biological assay of Diphtheria and tetanus anti toxins. (15)

8 a) Explain the quality control test for shaving creams and soaps. (7)b) Write any two methods for determination of Vitamin A. (8)

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Code No. 4140FACULTY OF PHARMACY

M. Pharmacy I-Semester (Common to All) (Main) Examination, March 2017

Subject: Pharmaceutical Analytical TechniquesTime: 3 Hours Max. Marks: 75


1 (a) Explain wood ward fisher rules for calculating absorption maximum forunsaturated hydrocarbons with an example. (7)

(b) Write about difference and derivative spectroscopy techniques. (8)

2 (a) Explain in brief about interpretation of IR spectra of organic compounds. (10)(b) Give the absorption frequencies of the following functional groups (5)

(i) Ester(ii) Aldehydes(iii) Carboxylic acids(iv)Alcohols(v) Amide

3 (a) Write about different derivation techniques used in gas chromatography. (8)(b) Give the different applications of HPLC techniques. (7)

4 Write short notes on the following: (15)(a) Principle of NMR(b) Chemical shifts in 1H-NMR(c) Spin-spin coupling in 1H-NMR

5 (a) Describe the principle and procedure involved in ELISA technique with anexample. (8)

(b) Give theory and principle involved in electrophoresis technique. (7)

6 (a) What is Nitrogen rule in mass spectrometry? Explain with suitable examples. (5)(b) Make a note on X-Ray crystallography (5)(c) Explain powder diffraction method with its applications (5)

7 (a) Discuss the principles of DTA and DSC techniques. (5)(b) Describe the two techniques used in getting DSC thermograms. (10)

8 Explain about the following : (3x5)(a) Column efficiency parameters(b) Mobile phase selection(c) Column packing materials

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M. Pharmacy (Pharmaceutics / PA & QA) I-Semester (Main) Examination, March 2017

Subject: Pharmaceutical Product DevelopmentTime: 3 Hours Max. Marks: 75


1 (a) Highlight the role of melting point and dissociation constant in the selection ofAPI’s. (8)

(b) Describe the evaluation techniques of pharmaceutical salts. (7)

2 (a) Explain the method of drug-excipient compatability studies with examples. (10)(b) Explain the role of disintegrants in the tablets formulation. (5)

3 (a) Describe the concept of complexation technique in solubility improvement of lowsoluble drugs. (9)

(b) Explain the aqueous solubility aspects in pre-formulation. (6)

4 (a) Explain the principle and procedure used for shelf-life assessment of drugs. (9)(b) Explain the influence of pH and solvent on drug stability. (6)

5 (a) Explain the influence of Hatch-Waxman Act of generics industry. (9)(b) Explain the concept of exclusivity in generic drug industry. (6)

6 (a) Explain the theories of drug dissolution. (6)(b) Write a note on : intrinsic solubility and intrinsic dissolution (5)(c) Describe In-Vitro and In-Vivo correlation and give its importance. (4)

7 (a) Explain in brief about the factorial design of experiment. (8)(b) How are the various additives influence the formulation development? (7)

8 Write a note on the following:(a) pH solubility profile (5)(b) Co-processing of excipients (5)(c) Solid dispersion (5)

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M. Pharmacy (P.A. & Q.A.) I-Semester (Main) Examination, March 2017

Subject: Quality Control of Health Related ProductsTime: 3 Hours Max. Marks: 75


1 Explain Quality control tests for(a) Shampoos for hair care (7)(b) Baby care products (8)

2 Write about the following:(a) UV and fluorescence analysis of powered drugs (8)(b) Micro chemical tests (7)

3 (a) Describe the principle and procedure involved in the biological assayof oxytocin. (7)

(b) What are antitoxins ? Give biological assay of Diphtheria antitoxin. (8)

4 (a) Explain the principles in the assay of ascorbic and by using2, 6 dichlorophenol indophenols and 3, 4 dinitro benzoic acid. (5)

(b) Write different methods for determination of quality control of vitamin E. (10)

5 (a) List out the quality control tests for fats and oils. Explain the principleand method details for determination of saponification value. (7)

(b) Explain the determination of ash and mineral constituents in foodconstituents. (8)

6 (a) Give analytical methods for determination of milk and milk products. (7)(b) Give the details of Kjeldahl method for determination of nitrogen and its

importance in pharmaceuticals. (8)

7 (a) Give any two methods for determination of vitamin B12. (7)(b) Explain Quality control tests for Eye care products. (8)

8 Discuss the biological assay of tetanus and rabies vaccines. (15)

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M. Pharmacy (Pharm. Analysis & Quality Assurance) I-Semester (Main) Examination,March 2017

Subject: Instrumental Methods of AnalysisTime: 3 Hours Max. Marks: 75


1 (a) Give the description and working of Transmission electron microscopy. Write aboutits pharmaceutical applications. (10)

(b) Write the applications of photon correlation spectroscopy for particle sizeanalysis. (5)

2 (a) Explain different endpoint evaluation methods for end point determination inpotentiometric titrations. (8)

(b) Write the principles of amperometry technique and about types of amperometrictitration. (7)

3 (a) Explain the phenomena of fluorescence and phosphorescence with help of Joblonskidiagram. (5)

(b) Give the description and working of different components of atomic absorptionspectrophotometer. (10)

4 (a) What are hyphenated techniques? Give the description and working of differentcomponents used in LC-MS instrument with a neat labeled diagram. (10)

(b) Draw a neat labeled diagram for LC-NMR. Discuss its principle and applications. (5)

5 (a) Explain the principle and theory involved in Raman spectroscopy. Give thedifferences between Raman and IR spectroscopy in application. (9)

(b) Write the principles and theoretical aspects of ORD and CD techniques. (6)

6 (a) Explain the principles of microbial assays and pharmacopoeial methods forevaluation of antimicrobial activity of antibiotics. (8)

(b) Write the significance of limit tests and how do you conduct limit test for iron asper IP. (7)

7 Write short notes on the following:(a) Wheatstone bridge (5)(b) Counter Current Apparatus (4)(c) Zeta meter (6)

8 (a) Describe different methods used for quantitative analysis of alkali metals by flamephotometry technique. (6)

(b) Explain about different sample preparation techniques used for sample preparationof phytochemical extracts for analysis. (9)

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M. Pharmacy (Pharmaceutics/PA&QA) I-Semester (Main) Examination, March 2017Subject: Quality Assurance

Time: 3 Hours Max. Marks: 75


1 (a) Describe in detail quality assurance of packing materials and finishedproducts. (7)

(b) Define quality control and quality assurance. Explain various functionsof both. (8)

2 Describe inprocess quality control of parenterals. What are various problemsencountered in the parenteral production. (15)

3 (a) Describe in detail ISO certification procedure. (10)(b) What are salient features of ISO 9000 series? (5)

4 Describe in detail different types of auditing. What do you mean by GMPauditing? (15)

5 (a) Describe operation systems and procedures in quality control lab. (8)(b) What are the various test methods and how will you evaluate the test

results in QC lab? (7)

6 Describe in detail good documentation practice. Write a note on RCA. (15)

7 (a) What are the sources of impurities? (5)(b) Explain any two impurity guidelines prescribed by WHO. (10)

8 Write a note on the importance of following in quality assurance system(a) Change control(b) Microbiological monitoring(c) Sanitation and maintenance

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Code No. 4097 / NFACULTY OF PHARMACY

M. Pharmacy (Common to All) I-Semester(New) (Suppl.) Examination, October 2016(Except Pharmacognosy / Ind. Pharm.)



1 (a) Explain the following terms with respect to UV-visible spectroscopy. (8)(i) Chromophore (ii) Auxo chrome(iii) Bathochromic shift (iv) Hypsochromic shift

(b) Describe the effect of conjugation and pH on UV absorption of organicmolecules. (7)

2 (a) Write the principle and instrumentation of Fourier Transform Infra Red (FTIR)spectrophotometer with a neat labeled diagram. List out its advantages overconventional IR instrument. (10)

(b) What are ‘IR active and IR inactive groups’? Give the absorption frequencies forthe following functional groups. (3+2)(i) Carboxylic acid (ii) Aldehyde (iii) Primary amine (iv) Alcohol

3 (a) What is spin-spin coupling? Explain with suitable examples. (8)(b) Explain the term ‘chemical shift’? Discuss the factors affecting chemical shift. (7)

4 (a) List out various ionization techniques in mass spectrometry. Explain electronimpact and chemical ionization techniques. (8)

(b) Explain the following:(i) Nitrogen Rule (7)(ii) Molecular ions(iii) Meta stable ion

5 (a) Give the principle of Gas chromatography. Explain any three derivatisationmethods. (9)

(b) Write the applications of Gas chromatography in pharmaceutical analysis. (5)

6 (a) Explain the principle and working of HPLC with a schematic diagram. (8)(b) Discuss the principle and applications of flash chromatography. (7)

7 (a) Write the principle and instrumentation of capillary electrophoresis. (7)(b) Explain the principle, applications and limitations of ELISA. (8)

8 (a) Explain Bragg’s equation and Miller indices. Write the applications ofcrystallographic studies. (8)

(b) Briefly explain the principle and working procedure of TGA. (7)

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M. Pharmacy (P.A. & Q.A.) II-Semester (New)(Main) Examination, October 2016

Subject: Analytical Method ValidationTime: 3 Hours Max. Marks: 75


1 Explain various parameters in analytical procedure validation. (15)

2 (a) Define Qualification and Calibration. (5)(b) Describe calibration of Analytical Balance (5)(c) Write a note on SPE (5)

3 Define and explain the following:(a) Prospective validation (5)

(b) Concurrent validation (5)(c) Revalidation (5)

4 Explain analytical method development and validation of UV-visiblespectrophotometers. (15)

5 (a) What are the factors to be considered in selection of a biological sample forquantification? (8)

(b) Explain principle and procedure of extraction of drug from biological sampleby membrane filtration. (7)

6 (a) Describe pharmaceutical water system validation. (8)(b) Discuss steps involved in validation master plan. (7)

7 (a) What are the factors to be considered in setting the limits of changingprocess validation? (7)

(b) What are the parameters to be considered in sterilization validation? (8)

8 (a) Define and explain DQ, IQ, OQ and PQ. (8)(b) Write the parameters to be considered for FT-IR validation. (7)

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M. Pharmacy (Pharm. Analysis / Quality Assurance) I-Semester (New) (Suppl.)Examination, October 2016



1 Explain the working principles and applications of the following techniques: (2x7½)(a) Confocal microscopy(b) Scanning electron microscopy

2 (a) Describe different techniques used for measurement of pH. (7)(b) Explain different types of conductimetric titrations and advantages over

titrimetric methods. (8)

3 (a) Give the description of plasma as excitation source in emissionspectroscopy. Give the description and working of inductively coupled plasmaspectrometer. (9)

(b) Give detailed note on different types of interferences and their elimination inAtomic Absorption Spectroscopy. (6)

4 Describe the different techniques used for particle size analysis. (15)

5 Write the IP methods for determination of the following physical parameters: (3x5)(a) Optical rotation(b) Relative density(c) Melting range

6 (a) Explain the phenomena of fluorescence and phosphorescence and discussabout different factors affecting the fluorescence and phosphorescencephenomena. (9)

(b) Write about amperometric titrations. (6)

7 (a) Explain about different sample preparation techniques used for samplepreparation of cell culture extracts for analysis. (7)

(b) Explain the principles of microbial assays and pharmacopoeial methods forevaluation of antimicrobial activity of antibiotics. (8)

8 (a) Write the principles and applications of LC-MS technique. (8)(b) Write the significance of limit tests and how do you conduct limit test for

lead as per IP. (7)

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M. Pharmacy (PA & QA) I-Semester (New) (Suppl.) Examination, November 2016



1 Explain quality control tests for(a) Baby care products (7)(b) Personal hygiene products (8)

2 (a) List out various WHO guidelines for quality control of Herbal products. (5)(b) Explain in detail about proximate analysis of crude drugs. (10)

3 Discuss the principle and procedure involved in biological assay of(a) Diphtheria (7)(b) Urokinase (8)

4 (a) Explain 2, 6 dichlorophenol idophenol method for determination of vitamin C. (7)(b) Explain carrprice colorimetric method for determination of vitamin A. (8)

5 (a) Explain the Gerber method for analysis of Fat in milk. (8)(b) Discuss the principle and procedure involved in determination of saponification

value. (7)

6 (a) Explain quality control tests for reserpine. (7)(b) Give any two methods for determination of Vitamin B12. (8)

7 Explain quality control tests for(a) Hair care products (7)(b) Eye care products (8)

8 (a) Explain Kjeldhal method for determination of Nitrogen and its importance inanalysis of pharmaceuticals. (8)

(b) Write a note on determination of Ash values. (7)

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Code No. 4101 / N

FACULTY OF PHARMACYM. Pharmacy (Pharmaceutics / PA & QA) I-Semester (New) (Suppl.) Examination,

November 2016

Subject : Quality Assurance

Time : 3 hours Max. Marks : 75

Note : Answer any FIVE questions. All questions carry equal marks.

1 a) Explain the basic concept of quality control and quality assurance. 5b) Describe in detail quality assurance of packing materials and finished products. 10

2 a) Explain the in process quality control tests for parenterals. 8b) Describe in detail problems encountered and their rectification in parenteral

production. 7

3 a) Explain in detail ISO 9000 series of standards. 8b) Explain the ISO certification process and it’s advantages. 7

4 a) Define auditing. Explain different types auditing. 6b) Describe in detail GMP auditing. 9

5 a) Describe desirable qualities and responsibilities of analyst. 7b) Describe safety guidelines to be followed in a QC lab. 8

6 a) What do you mean by good documentation practice, describe in detail howdocumentation plays an important role in QA? 7

b) Write in detail corrective and preventive action. What is the difference betweenOOS and OOT? 8

7 Explain in detail ICH Q3B and Q3C guidelines for impurities. 15

8 a) Explain in detail the concept of purity angle. 8b) Discuss the evolution of IP, BP, USP and compare the policies. 7

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M. Pharmacy (Common to All) I-Semester (New) (Main) Examination, April 2016(Except Pharmacognosy / Ind. Pharm.)



1 (a) Explain Woodward – Fieser rules for calculating max for unsaturatedhydrocarbons. (5)

(b) Describe various electronic transitions in UV-visible spectroscopy. (5)(c) List out different IR instruments and discuss their advantages and

Disadvantages. (5)

2 (a) Describe various sample-handling techniques for IR spectroscopy. (8)(b) Write a short note on 13C NMR. (7)

3 (a) How do you determine the molecular formula of a compound with the followingisotopic abundance? (6)

M+ M+1 M+2m/z 94 95 96% R.A. 100 1.1 98

(b) Explain the following with examples. (9)(i) Nitrogen Rule(ii) Shielding and deshielding(iii) Spin-spin coupling

4 (a) Explain the principle of gas chromatography and discuss instrumentation of GCwith a labeled diagram. Give its applications. (9)

(b) Describe the principle and working of any two detectors used in GCinstruments. (6)

5 (a) Explain the principle of HPLC. Describe the stationary phases used in HPLCinstruments. (8)

(b) Discuss the principle and applications of supercritical fluid chromatography. (7)

6 Write a note on :(a) Miller indices and Bragg’s equation (8)(b) SDS-gel electrophoresis (7)

7 (a) Write the principle and instrumentation of zone electrophoresis. (7)(b) Explain the principle, applications and limitations of RIA. (8)

8 (a) List out different thermal analytical techniques. Briefly explain the theory,instrumentation and applications of DSC. (10)

(b) Explain the rotating crystal technique for X-ray diffraction studies. (5)

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M. Pharmacy (Pharm. Analysis & Quality Assurance) I-Year I-Semester(New) (Main)Examination, April 2016



1 (a) Give the principle, description and working of scanning electron microscope. Writedifferent applications of SEM. (10)

(b) Give the principles of ORD and CD techniques. (5)

2 (a) Give the description and working of inductively coupled plasma spectrometer. (10)(b) Explain about different types of interferences and their elimination in Atomic

absorption spectroscopy. (5)

3 (a) Write about different types of membrane indicator electrodes used inpotentiometry. (10)

(b) Explain the Wheatstone bridge principle in conductivity measurements. (2)(c) Define Specific conductance, Molar conductance and Equivalent conductance. (3)

4 (a) Discuss about different factors affecting the fluorescence and phosphorescencephenomena. (9)

(b) Explain the principles and list of different fuel gases and oxidants used in flamephotometry technique. (6)

5 (a) What are hyphenated techniques? Give the description and working of differentcomponents used in GC-MS instrument with a neat labeled diagram. (10)

(b) Give the principles and theoretical aspects of Raman spectroscopy. (5)

6 Describe different techniques used for particle size analysis along with their applicationsin pharmaceutical preparations. (15)

7 Write short notes on the following:(a) Chemiluminescence (5)(b) Counter Current Apparatus (5)(c) Wheatstone Bridge Principle (5)

8 (a) Write about different sampling techniques for preparation of plasma and tissueextracts for analysis. (10)

(b) Give the significance of limit tests and how do you conduct limit test for chloride asper IP. (5)

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M. Pharmacy (Pharmaceutics / PA & QA) I – Semester (New) (Main) Examination,April 2016

Subject : Pharmaceutical Product Development



1 a) Explain the role of salts, prodrugs on the selection of drugs in the preformulationstudies. 10

b) Explain the features of aqueous solubility in selecting a drug for drug design inpreformulation studies. 5

2 a) Describe the method of testing compatability of drugs and additives duringformulation development.

b) Explain various mechanisms of disintegrants with suitable examples. 9+6

3 a) Discuss the various types of additions and basic materials used as ointmentbases. 10

b) Write about colouring agents. 5

4 a) Explain dissolution apparatus with labeled diagram for the evaluation ofconventional and controlled release productions.

b) What are sink and non-sink conditions? Explain how these conditions aresimulated in dissolution studies. 10+5

5 Describe briefly on 15a) Energy of activation b) Design of experimentsc) Biorelavant media d) Nano carriers

6 a) Describe the salient features, kinetic method and limitations of acceleratedstability studies for drug products.

b) Explain the method for solid state stability kinetics. 10+5

7 a) Highlight the nanopharmaceuticals emphasizing on their generation andsignificance.

b) Describe briefly on generic drug product development. 9+6

8 a) Describe the applications, advantages and limitations of factorial designs.b) Explain the rules used in the simplex matrix design.c) Describe the role of polymorphism in the formulation. 5+5+5

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Code No. 6101 / N

FACULTY OF PHARMACYM. Pharmacy (Pharmaceutics / PA & QA) I – Semester (New) (Main) Examination,

April 2016Subject : Quality Assurance



1 a) Explain the basic concept of quality control and quality assurance. 5b) Describe in detail quality assurance of raw materials and API. 10

2 a) Explain the inprocess quality control tests for emulsions and suspensions. 8b) Describe in detail problems encountered and their rectification in the production

of disperse system. 7

3 a) Explain in detail quality management principles of ISO. 8b) Explain the ISO certification procedure and it’s advantages. 7

4 a) Define auditing. Explain different types auditing. 6b) Describe in detail GMP auditing. 9

5 a) Describe desirable qualities and responsibilities of analyst. 6b) Describe operation systems and procedures of QC lab. 9

6 a) Explain the importance of documentation in quality assurance department 7b) Write in detail corrective and preventive action. What is the difference between

OOS and OOT? 8

7 Explain in detail ICH Q3C and Q3D guidelines for impurities. 15

8 a) Explain in detail concept of peak purity. 9b) Compare the policies of IP, BP, USP. 6

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M. Pharmacy (PA & QA) I-Semester(New) (Main) Examination, April 2016



1 Explain quality control tests for :(a) Hair care products (7)(b) Personal hygiene products (8)

2 How do you determine and check the quality of crude drugs with ash values, swellingindex and extractive values? (15)

3 (a) Explain the principles and details of methods for biological assay of oxytocin. (7)(b) What are antitoxins? Give biological assay of Diphtheria antitoxin. (8)

4 Write different methods for determination of vitamin B12. (15)

5 (a) Explain any two methods for determination of proteins. (7)(b) Explain any two methods for determination of fats and oils. (8)

6 (a) Explain the determination of ash and mineral constituents in food constituents. (7)(b) Explain the fluorescence analysis of powdered drugs. (8)

7 (a) Explain Gerber method for analysis of fat in milk. (8)(b) Explain the principle and procedure involved in determination of acid value. (7)

8 (a) Explain quality control tests to check the irritation of Baby care products. (7)(b) Explain any one method for determination of vitamin A. (8)

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