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GUJARAT TECHNOLOGICAL UNIVERSITY
BE- SEMESTER-VII (NEW) EXAMINATION - WINTER 2020
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Subject Code:2173602 Date:19/01/2021Subject Name:Process Technology of Drugs & Intermediates
Time:10:30 AM TO 12:30 PM Total Marks: 56
Instructions:
- Attempt any FOUR questions out of EIGHT questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
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MARKS
Q.1 (a) Define: (1). Validation, (2). Qualification, (3). GMP 03
(b) Define chiral auxiliary. Describe the use of chiral auxiliary with a 04 schematic diagram. Write one example of the use of chiral auxiliary.
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(c) List out the techniques in identifying exothermicity & gas 07 generation. Briefly explain them. Illustrate use of calorimetry in designing safe scale up process with two examples.Q.2 (a) What are super critical solvents? Give an example. What are the 03 advantages & disadvantages of super critical solvents?
(b) Describe the working of simulated bed chromatography with 04 diagram. What are the advantages & disadvantages?
(c) What are the classifications of Enzymes? Write in detail about 07 Lipases & Esterases with suitable examples of reactions catalyzed by them.
Q.3 (a) Write a note on “sources of enzyme” 03
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(b) Discuss Ultra filtration & Microfiltration 04(c) Explain the different types of Process validations. What are the 07 types of validation documents?
Q.4 (a) Define process safety. Write a note on the types of hazards 03
(b) Explain Marckwald principle & Reciprocal resolutions. Illustrate 04 with example.
(c) Describe the need, different types of “Qualifications” in 07 Pharmaceutical industries. Explain qualification protocol.
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Q.5 (a) Define adsorption. Write the theory & factors affecting adsorption. 03
(b) Describe process safety failures and the consequences. 04
(c) Write briefly the factors to be considered while selecting filtration 07 equipment. Describe any two filtration equipments with neat diagrams.
Q.6 (a) What are the selection criteria for resolving agents. Give one 03 example of the use of resolving agent.
(b) Describe residual solvents? Write a note on the classification of 04 solvents by risk assessment.
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(c) Discuss in detail the optimization of process. Illustrate with suitable 07 examples.FirstRanker.com
Q.7 (a) Write a brief account on “Regulation of Enzyme activity” 03
(b) Define “reagent”? Explain the properties to be considered while 04 selecting a reagent.
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(c) List out the factors to be considered while choosing solvent and 07 explain them.Q.8 (a) Write a note on (1) Ion exchange chromatography, (2). Gel 03 filtration chromatography
(b) Write a note on Phase transfer catalyst. What are the factors to be 04 considered while choosing a Phase Transfer Catalyst (PTC) & how selectivity in PTC can be achieved?
(c) Describe two methods of resolution of racemates by direct 07 crystallization with suitable examples.
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