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Code No. 12083/CBCS FACULTY OF PHARMACY

M. Pharmacy (Common to All) II-Semester (CBCS) (Backlog) Examination, July 2021

Subject: Intellectual Property Rights and Regulatory Affairs

Time: 2 Hours Max. Marks: 75

Note: Answer any three questions. (3x25=75 Marks)

1 Describe in detail patent filing procedures.

2 Write a note on : (a) Copyright and geographical Indications (b) Amendment of Patent Act 3 Explain ICH guidelines in quality management system. 4 Write a note on : (a) MSDS Preparation (b) Industrial safety management 5 Explain in detail Investigational New Drug (IND) guidelines. 6 Discuss Drugs and Cosmetics Act, 1940. 7 Explain : (a) Prevention of Food Adulteration Act 1954 (b) Consumer Protection Act 8 Explain PICS Guidelines in Basic requirements of medicinal products.

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M. Pharmacy (Pharm. Chemistry) II-Semester (CBCS) (Backlog) Examination, July 2021

Subject: Advanced Pharmaceutical Organic Chemistry – II



1 Write the mechanisms and synthetic application of following reactions: (a) Reformatsky reaction (b) Mannich reaction 2 Write in detail about : (a) Strategic approaches in Retro synthesis (b) Consecutive Synthesis (c) Identification of Strategic bonds in Rings

3 Define pericyclic reactions and explain in detail about Frontier molecular orbital theory and Woodward Hoffmann rules. 4 Write the synthetic approaches of the following heterocycles. (a) Benzimidazole (b) Quinoline (c) Benzofuran 5 Write a short note on: (a) Phase transfer catalysis (b) Claisen rearrangement 6 Explain various strategies employed in optimization and scale up of synthetic routes. 7 Explain in detail about : (a) Principle and applications of green chemistry. (b) Synthetic approaches of Benzodiazepines 8 Explain in detail about: (a) Reaction mechanism and synthetic applications of Claisen Ester condensation.

(b) Cycloaddition and Sigmatropic reactions.

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M. Pharmacy (Pharmaceutical Chemistry) II-Semester (CBCS) (Backlog) Examination, July 2021

Subject: Advanced Medicinal Chemistry – II



1 What are prodrugs? Explain in detail about applications of prodrugs. 2 Explain in detail about soft analogues, active metabolic and inactive metabolite- based soft drug approaches with examples. 3 Explain the rational design of ACE inhibitors.

4 Give the classification of antimalarial agents. Write the mechanism of action, synthesis and SAR of any two classes of the same. 5 List out the targets for Parkinson’s disease treatment. Write the mechanism, synthesis and SAR of any two classes of the drugs. 6 Explain in detail about the targets for treatment of tuberculosis. Write the synthesis, SAR and metabolism of any one class (only one example). 7 Explain the rational design of carbonic anhydrase inhibitors. 8 Write a note on chemistry of drugs used in the treatment of Alzheimer’s disease.

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Code No: 13125/CBCS

FACULTY OF PHARMACYM. Pharmacy (Common to all) II-semester (CBCS) (Backlog) Examination,

August 2019Subject: Intellectual Property Rights & Regulatory Affairs

Time: 3hrs Max Marks: 75

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

1. a) Explain patent Application and patent processing. (10)b) Write a note on copyrights (5)

2. Explain in detail OECD guidelines. (15)

3. Explain the structure and functions of WTO. (15)

4. Explain in detail about FDA guidelines for submission of IND. (15)

5. Discuss in detail about schedule Y. (15)

6. Discuss ICH guidelines for quality, safety and efficacy. (15)

7. a) Explain Food Adulteration Act 1954. (10)b) Write a note on Consumers protection Act. (5)

8. (a) Explain in detail about Industrial development & regulation Act 1951. (10)(b) Write a note on MSDS preparation. (5)

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Code No: 13127/CBCS

FACULTY OF PHARMACYM. Pharmacy (Ph. Chemistry) II-semester (CBCS) (Backlog) Examination,

August 2019Subject: Advanced Pharmaceutical Organic Chemistry- II

Time: 3 hrs Max Marks: 75


1. Explain the mechanism and synthetic applications of following reactions:a) Claisen ester condensation. (8)b) Reformatsky reaction. (7)

2. Outline the various routes of synthesis of following condensed hetero cycles.a) Quinoline (5)b) Benzo diazepine. (5)c) Chromene (5)

3. Define preicyclic reactions and explain in detail about Cope-rearrangement andClaisen rearrangement. (15)

4. Write a note on the following:(a) Various disconnection approaches. (8)(b) How will you identify the strategic bonds in ring structures? Explain with

examples. (7)

5. Define green chemistry and describe in detail about the principles and applications ofgreen chemistry. (15)

6. Write a note on the following.a) Scale up process. (7)b) How will you optimize the yield and purity in synthetic reactions? (8)

7. Define phase transfer catalysis and describe in detail about mechanism andapplications of phase transfer catalysis. (15)

8. Outline the various synthesis of following.(a) Pyrinidine. (5)(b) Imidazole (5)(c) Thiazole (5)

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Code No: 13128/CBCS

FACULTY OF PHARMACYM. Pharmacy (Ph. Chemistry) II-Semester (CBCS) (Backlog) Examination,

August 2019Subject: Drug Screening methods



1. a) Write a note on principles of replications (5)b) Describe in brief about control charts and statistical quality control. (5+5)

2. a) Describe in detail about high throughput screening. (10)b) Write a note on dose effect relationship. (5)

3. a) Write a note on probit analysis. (5)(b) Write the procedure for determination of LD50 as per OECD-425 Guideline. (10)

4. (a) Name the screening methods for anti-diabetic agents. Explain any two models. (2+8)(b) Write a note on writhing test. (5)

5. a) Name screening methods for cardio tonic agents. Explain any two models. (2+8)b) Write a note on MTT assay. (5)

6. a) Name the screening methods for anti-depressants. Explain any two models. (2+8)b) Write a note on MES model in rats. (5)

7. a) Explain any one screening model for diuretic drugs and anti-fertility agent. (8)b) Write a note on types of bioassay. (7)

8. Write a note on:(a) Ed50 (5)(b) Principles of local control (5)(c) Paw edema in rats (5)

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Code No: 13126/CBCS

FACULTY OF PHARMACYM. Pharmacy (Ph. Chemistry) II-semester (CBCS) (Backlog) Examination,

August 2019Subject: Advanced Medicinal Chemistry- II



1. Define prodrugs and explain in detail about various derivatives of prodrugs and theirapplications. (15)

2. What is meant by “Soft drugs”? Explain about the various concepts of soft drugapproach and write the applications. (15)

3. Write in detail about the following.a) ACE inhibitors. (7)b) PDE inhibitors. (8)

4. Explain the various targets, mechanism of action, classification and synthesis of anytwo antitubercular drugs. (15)

5. a) Explain in detail about the life cycle of malarial parasite and mention the drugsused to inhibit the various stages. Classify antimalarial drugs with examples. (10)b) Write the SAR of 8-amino quinolines. (5)

6. Define antiparkinsonism agents and briefly explain about their targets, classification,mode of action and synthesis of any three drugs. (15)

7. Write short notes ona) Anti alzheimer’s agents. (8)b) Rational design of cox-1 and cox-2 inhibitors. (7)

8. Write in detail about the following(a) Carbonic anhydrase inhibitors. (7)(b) HMG CoA reductase inhibitors. (8)

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Code No: 13129/CBCS


August 2019Subject: Herbal Drug Development Standardization (Elective)

Time: 3 hrs Max Marks: 75


1. a) Write in detail about the requirements and applications of herbal drug industry. (8)b) Explain about the documentation procedure in herbal drug industry. (7)

2. a) Describe about the quality control methods for medicinal plant material. (8)b) Write about the herbal drug interactions with food and allopathic drugs. (7)

3. Write short note on:a) Preparation and standardization of tablets. (8)b) Standard Operating procedures for drying and compression. (7)

4. Describe in detail about the basic concepts ofa) Total quality Management. (8)(b) Change control program (7)

5. Explain in detail about the NABL certification and accreditation procedure of quality ofassurance. (15)

6. a) Explain about the quality audits EQ(DQ, IQ. OQ, GPQ) (8)b) Write about CPCSEA guidelines. (7)

7. Explain about the screening of natural products for immune modulatory and anti-ulceractivity. (15)

8. List the pharmacological screening method for herbal antidiabetic and antihypertensiveactivity. (15)

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Code No: 13130/CBCS


August 2019Subject: Research methodology & Biostatistics (Elective)



1. Explain (i) Measure of central tendency. (9)(ii) Histogram and ogive curve. (6)

2. i) Explain Correlation and Regression. (6)ii) Find Regression equations to the following data. (9)

X 26 31 36 33 38 34 17 32 31Y 43 48 60 49 62 57 45 53 51

3. Explain about:i) Systematic Sampling (5)ii) Cluster Sampling (5)iii) Binomial Distribution and Poison Distribution. (5)

4. Explain abouti) Null hypothesis and alterative Hypothesis (5)ii) Sampling Errors (5)iii) Chi-Square test of goodness of fit.

5. Explain abouti) Analysis of variance one-way classification with ANOVA table. (8)ii) Completely Randomized Design. (7)

6. i) Discuss the format of thesis and dissertation. (9)ii) What is meant by a report? (6)

7. Explain about:i) Research Reviews (5)ii) Bibliography (5)iii) Oral Presentation (15)

8. Explain abouti) Basic Principles of Designs of Experiment. (8)ii) Patent writing and filing (7)

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Code No: 13131/CBCS

FACULTY OF PHARMACYM. Pharmacy (Pharmaceutical Chemistry) II Semester (CBCS)(Backlog)

Examination, August 2019Subject: Bulk Drug Technology (Elective)

Time: 3 Hours Max Marks: 75Note: Answer any Five Questions. All Questions carry Equal marks

1. a) What are industrial effluents? Explain in detail about the effluent treatmentmethods. (10 M)

b)Give a note on pollution control measures. (05 M)

2. a) Explain about the process involved in the manufacture of sulphathiazole withprocess flow diagram. (09 M)

b) What is acetylation? Explain the reaction mechanism involved in the acetylationand mention its pharmaceutical applications (06 M)

3. Explain the reaction mechanism and industrial applications of the following chemicalprocesses. (15 M)

i). Halogenation.ii). Nitration.iii). Oxidation. .

4. Explain in detail about the following drug synthesis unit operations. (15 M)i). Filtration.ii). Centrifugation.iii). Crystallization.

5. a) Explain about the manufacture of chloramphenicol by fermentation with processflow diagram. (10 M)

b) Outline the manufacturing process flow chart for the anuerine (Vitamin B1). (05 M)

6. a) Give a note on design and construction of (10 M)i). Continuous-stirred tank reactorii). Fluidised bed reactor.

b) Explain about the significant factors to be considered in the design of chemicalreactors. (05 M)

7. a) Give a note on the mixing and drying processes involved in the drug synthesis. (10 M)b) Outline the reaction mechanism involved in one pharmaceutically important

rearrangement reaction. (05 M)

8. a) What are industrial hazards? Give a detailed note on the monitoring andpreventive systems for industrial hazards. (10 M)

b) Enumerate different types of industrial accidents and list important safety devicesused in the drug industry. (05 M)

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Code No. 1320 / CBCSFACULTY OF PHARMACY

M. Pharmacy (Common to All) II-Semester (CBCS) (Backlog) Examination,August 2018

Subject: Intellectual Property Rights and Regulatory Affairs


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

1 Write a note on :(a) Patent filing procedures (10)(b) Trademark (5)

2 Discuss in detail schedule ‘M’ as per Drugs and cosmetics Act and Rules. (15)

3 Discuss indetail about ICH guidelines. (15)

4 (a) Explain in detail Regulation of import and export of drugs. (8)

(b) Write a note on submission of marketing application of India. (7)

5 (a) Discuss in detail FDA guidelines on NDA. (10)

(b) Write a note on Generic Drug products. (5)

6 (a) Write a note on Industrial safety. (10)

(b) MSDS preparation (5)

7 (a) Discuss the objectives and functions of WIPO. (10)

(b) Write a note on TRIPS. (5)

8 Write a note on :(a) Industrial effluent testing and treatment (7)

(b) Control of Environmental pollution (8)

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M. Pharmacy (Ph. Chemistry) II-Semester (CBCS) (Backlog) Examination,August 2018

Subject: Advanced Pharmaceutical Organic Chemistry – II



1 Explain the mechanism and synthetic applications of following reactions:(a) Michael addition (7)(b) Mannich reaction (8)

2 Outline the various routes of synthesis of following:(a) Benzimidazole (5)(b) Quinazoline (5)(c) Indole (5)

3 (a) Define pericyclic reactions. Classify various types of pericyclic reactions.(b) Explain the mechanism of cycloaddition reactions (2+2) and (4+2) using

Frontier molecular orbital theory and predict the conditions. (15)

4 Write in detail about the following:(a) Consecutive synthesis (5)(b) Convergent synthesis (5)(c) Strategic approaches in retro synthesis (5)

5 Define phase transfer catalysis, and explain the mechanism and applications ofphase transfer catalysis. (15)

6 Write a note on the following:(a) Scale up process (7)(b) Optimization of synthetic routes (8)

7 Explain about Frontier molecular orbital theory and Huckel mobius theory withexamples for electrocyclic reactions and predict the conditions. (15)

8 Outline the various synthetic routes for following heterocyclic rings(a) Pyrimidine (5)(b) Thiazole (5)(c) Oxazole (5)

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Subject: Research Methodology and Biostatistics (Elective)



1 Calculate Mean, Median and Mode to the following distribution. (15)

Class Interval 30-40 40-50 50-60 60-70 70-80 80-90Frequency 18 37 45 27 15 8

2 Explain about : (5+5+5)(a) Binomial Distribution and Poisson Distribution(b) Simple Random Sampling(c) Bayesian Estimation

3 Explain about: (5+5+5)(a) Correlation and Regression(b) Chi Square test of goodness of Fit(c) Sign Test

4 Explain about :(a) Parametric and Non-Parametric Tests (8)(b) t-test for difference of Means (7)

5 Explain about :(a) Basic Principles of Design of Experiments (7)(b) Randomized Block Design (8)

6 Define Research Problem. What are the Objectives of Research? Discuss varioustypes of research? (15)

7 What is meant by a report? Discuss various steps which are involved in writingReport. (15)

8 Explain about : (5+5+5)(a) Bibliography(b) Patent writing and filling(c) Analysis of variance one way classification

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Subject: Herbal Drug Development & Standardization (Elective)



1 (a) Explain in detail about the immunomadulator drugs and their importance. (8)

(b) Write about the screening techniques of immunomodulators. (7)

2 (a) Describe about the process validation principle and procedures. (8)

(b) Write about the quality auditsEQ (IQ, DQ, OQ, PQ). (7)

3 Describe about :(a) Preparation and standardization of herbal ointments. (8)

(b) Preparation and standardization of herbal tablets. (7)

4 Write in detail about the herbal interaction (Herb-Herb interaction. Herb-foodinteraction, Herb-drug interaction). (15)

5 (a) Write about the organizations involved in research and development ofnatural products. (8)

(b) Write about the standard operating procedures for disinfection. (7)

6 List the methods of quality control for medicinal plant material and total qualitymanagement. (15)

7 (a) Write about the preparation and Ideal properties of shampoos. (8)

(b) Write about the preparation and ideal properties of face packs. (7)

8 Write short notes on :(a) Calculation of LD50 and ED50 (5)(b) Chi-square test (5)(c) Control charts (5)

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Subject: Drug Screening MethodsTime: 3 Hours Max. Marks: 75


1 (a) Write a note on principles of randomization. (5)(b) Describe in brief about control chart and sampling techniques. (5+5)

2 (a) Explain about scintillation proximity assay and reporter gene assay. (5+5)(b) Write a note on bioassay design. (5)

3 (a) Define the term LD50 and ED50. Explain their significance. (5)(b) Write the procedure for determination of LD50 as per OECD-425

Guideline. (10)

4 (a) Name the screening methods for analgesics. Explain any two models. (2+8)(b) Write a note on LIPSCHITZ test. (5)

5 (a) Name the screening methods for anti-hypertensive agents. Explain any twomodels. (2+8)

(b) Write a note on swim despair test. (5)

6 (a) Name the screening methods for anti-epileptic agents. Explain any twomodels. (2+8)

(b) Write a note on paw edema method in rats. (5)

7 (a) Explain any one screening model for cardio-tonic and anti-fertility agents. (8)(b)Write a note on probit analysis. (7)

8 Write a note on : (15)(a) Plyorus ligation method in rats(b) Principles of replication(c) Advantages of bioassays

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Subject: Advanced Medicinal Chemistry - IITime: 3 Hours Max. Marks: 75


1 Define the term prodrugs. Explain in detail about the various derivatives ofprodrugs and their applications. (3+12)

2 Write a note on the following:(a) Soft drug concept with examples. (8)(b) Applications of soft drug concept. (7)

3 Write in detail about the following:(a) Carbonic anhydrase inhibitors (8)(b) HMG CoA reductase inhibitors (7)

4 Write the classification of anti tubercular agents and synthesis of any threedrugs. (6+9)

5 Classify antimalarial drugs and outline the synthesis of any three drugs. (6+9)

6 Write a note on the following:(a) ACE inhibitors (7)(b) PDE inhibitors (8)

7 Write the various targets of anti-Parkinsonism agents and classify them withexamples. Write the synthesis and metabolic pathway of any two drugs.(4+4+7)

8 Write a note on the following:(a) SAR of 4-amino quinolines (7)(b) Targetted prodrugs (8)

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Code No. 1326/CBCSFACULTY OF PHARMACY


Subject: Bulk Drug Technology (Elective)Time: 3 Hours Max. Marks: 75


1 Explain the reaction mechanism, reagents and applications of the following indrug manufacturing reactions. (3x5)(i) Halogenation

(ii) Hydrolysis(iii) Reduction

2 Explain the principle and applications of the following unit operations withrespect to drug synthesis with suitable examples. (3x5)(i) Drying(ii) Crystallization(iii) Counter-current extraction

3 (a) Explain about esterification reactions and manufacture of benzocaine withprocess flow diagram. (9)

(b) Explain about fermentation and manufacture of chloramphenicol givingprocess flow diagram. (6)

4 (a) Explain the reaction mechanism and unit operations involved in themanufacture of aspirin and sulphathiazole. (12)

(b) Highlight the significant role of mixing in drug manufacture. (3)

5 Give a note on :(i) Basic elements of reactor design. (7)(ii) Design and construction of continuous stirred tank reactor (CSIR) or

Fludised bed reactor. (8)

6 (a) Give a detailed note on the monitoring and preventive systems for industrialhazard management. (7)

(b) Enumerate different types of industrial accidents and explain about theimpact of industrial accidents in pharmaceutical manufacturing. (8)

7 Explain the reaction mechanism, industrial method and applications of :(i) Nitration (ii) Chlorosulphonation (15)

8 (a) What are industrial effluents? Explain in detail about the testing and treatmentof effluents. (10)

(b) Give a note on industrial safety and enlist important safety devices used inthe drug synthesis industry. (5)

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Code No. 4112 / NFACULTY OF PHARMACY

M. Pharmacy (Common to All) II-Semester (New)(Main) Examination, October 2016

Subject: Intellectual Property Rights and Regulatory AffairsTime: 3 Hours Max. Marks: 75


1 (a) What is a Patent? Explain the procedure for filing an application for patent inIndia. (10)

(b) Write briefly about trademarks and their uses. (5)

2 (a) Discuss the objectives and functions of WTO. (9)(b) Explain the importance of TRIPS on Indian pharmaceutical industry. (6)

3 Write a detailed note on requirements and guidelines of GMP (schedule M) inPharma industries. (15)

4 Discuss the ICH guidelines in detail with reference to registration of pharmaceuticalsglobally. (15)

5 Discuss the salient features of documentation required for submission of NDA. (15)

6 Write short notes on :(a) Material safety data Street (MSDS) (5)(b) OECD guidelines for clinical studies (5)(c) Generic products (5)

7 Discuss the salient features of pollution control regulation. (15)

8 Explain in detail about export and import of drugs. (15)

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M. Pharmacy (Ph. Chemistry) II-Semester (New) (Main) Examination, October 2016

Subject: Advanced Medicinal Chemistry - IITime: 3 Hours Max. Marks: 75


1 What is the importance of the following in biotransformation of drugs: (8+7)(a) Prodrugs(b) Soft drugs

2 Discuss in detail rational design of following enzyme inhibitors. (8+7)(a) Anglotensin converting enzyme inhibitors(b) Cyclooxygenase inhibitors

3 (a) Mention various stages of the parasite that causes malaria and indicate site ofantimalarial drug action. (10+5)

(b) Explain the SAR of Dopamine receptor agonists.

4 Write synthesis therapeutic applications and metabolism of following drugs. (5+5+5)(a) Primaquine(b) Trihexyl phenidyl HCl(c) Besipiridine

5 Write a note on : (8+7)(a) Carbonic anhydrase inhibitors(b) HMG CoA reductase inhibitors

6 (a) Write about Anti tubercular agents with their mechanism of action. (8)(b) Write synthesis, mechanism of action and therapeutic applications of

Biperiden. (7)

7 Discuss in detail about : (5+5+5)(a) Prodrug applications(b) Soft Analogues(c) Lipoxygenase inhibitors

8 Write a note on: (5+5+5)(a) Phosphodiesterase inhibitors(b) Future trends in prevention of malaria(c) Synthesis of pyrimethamine

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M. Pharmacy (Ph. Chemistry) II-Semester (New) (Main) Examination, October 2016

Subject: Advanced Pharmaceutical Organic Chemistry - IITime: 3 Hours Max. Marks: 75


1 Write the reaction, applications and mechanism of the following: (7+8)(a) Perkin reaction(b) Micheal Addition

2 Explain the following :(a) Consecutive Vs Convergent synthesis (10)(b) Identification of strategic bonds in rings (5)

3 Outline the synthetic approaches of the following heterocyclic systems (5+5+5)(a) Benzimidazole(b) Quinazoline(c) Benziosoxazole

4 Explain different mechanisms (theories) involved in pericyclic reactions forElectrocyclic reactions and predict the conditions. (15)

5 Explain various strategies employed in optimization and scale up of syntheticroutes. (15)

6 Define strategic bond. Discuss different strategic approaches in Retrosynthesis. (15)

7 Write short notes on :(a) Phase Transfer catalysis (5)(b) Cope Rearrangement (5)(c) Principles of Green chemistry (5)

8 Discuss different types of pericyclic reactions with suitable examples. (15)

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M. Pharmacy (Ph. Chemistry) II-Semester (New) (Main) Examination, November 2016

Subject: Herbal Drug Development Standardization (Elective)



1 (a) Write in detail about the infrastructure and equipment requirements of herbaldrugs industry. (8)

(b) Write about down the organizations involved in herbal drug industry. (7)

2 (a) Write about the batch formula records for documentation in herbal drugindustry. (8)

(b) Write about the advantages and recent research in herbal products. (7)

3 (a) Describe about the methods for preparation of herbarium. (8)(b) Write about the evaluation and standardization of procedure of herbal

drugs. (7)

4 (a) Define herbal shampoos and explain about their preparation andstandardization techniques. (8)

(b) Write about the problems in standardization of herbal medicine. (7)

5 Describe in detail about the basic concepts of(a) Quality control (8)(b) Quality assurance (7)

6 (a) Discuss about the herbal anti inflammatory drugs and their importance. (8)(b) List out the anti-inflammatory screening techniques with their merits and

demerits. (7)

7 List the pharmacological screening methods for analgesics and antihypertensiveactivity. Explain any two methods for each category. (15)

8 (a) Define herbal cosmetics and their applications (5)(b) Preparation of face packs (5)(c) Standardization of face packs (5)

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M. Pharmacy (Ph. Chemistry) II-Semester (New) (Main) Examination, November 2016

Subject: Research Methodology and Biostatistics (Elective)



1 Explain :(a) Mean, Median, Mode (9)(b) Standard deviation and Coefficient of Variation (6)

2 (a) Explain Correlation and Regression. (6)(b) Find Correlation coefficient to the following data: (9)

X 16 21 26 23 28 24 17 22 21Y 33 38 50 39 52 47 35 42 41

3 Explain about : (5+5+5)(a) Simple Random Sampling(b) Stratified Random Sampling(c) Normal Distribution

4 Explain about: (5+5+5)(a) Null hypothesis and alternative Hypothesis(b) Type I and Type II Errors(c) Level of Significance

5 Explain about :(a) Basic Principles of Design of Experiments. (6)(b) Analysis of variance one – way classification with ANOVA Table. (9)

6 What is research Problem? Define the main issues which should receive theattention of the researcher in formulating the research problem. (15)

7 What is meant by report? What are various stages of writing report? (15)

8 Explain about:(a) Patent writing and filing (8)(b) Randomized Block Design (7)

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M. Pharmacy (Ph. Chemistry) II–Semester (New) (Main) Examination, November 2016Subject: Bulk Drug Technology (Elective)

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

1 a) Define and explain the terms “Unit operation” and “Unit process” with any fivesuitable examples of each. 6

b) What are the various manufacturing methods of bulk drugs? 9

2 Define and explain the reaction mechanism and their application in the chemicalprocess industries with suitable examples. 15i) Nitrationii) Sulphonationiii) Alkylation

3 a) Distinguish between evaporation, distillation and drying. 6b) Write a brief note on the following: 9

i) Filtrationii) Extraction

4 Explain in detail the reaction and various steps involved (unit operations and unitprocesses) in the manufacture of aspirin with a neat process flow diagram. 15

5 What is fermentation? How do you manufacture chloramphenicol by using fermentationprocess? Explain with a neat flow diagram. 15

6 a) What factors need to be considered for reactor design? 6b) With a neat diagram, explain about design of a kettle type batch reactor. 9

7 a) Define and classify “Industrial hazards”. 6b) Write in brief about various sources of industrial hazards and write their preventional

methods. 9

8 a) What is process safety? Name some of the safety appliances and devices that canbe used in the bulk drug industries. 7

b) Write brief note on any one of the major “Industrial accident case study”. 8

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faculty of pharmacy m. pharmacy (common to all) ii

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