GTU BE/B.Tech 2017 Winter Question Papers || Gujarat Technological University
Subject Code: 2173602
GUJARAT TECHNOLOGICAL UNIVERSITY
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BE - SEMESTER-VII (NEW) EXAMINATION — WINTER 2017
Date: 02/11/2017
Subject Name: Process Technology of Drugs & Intermediates(Department Elective - VII)
Time: 10:30 AM TO 01:00 PM
Instructions:
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- Attempt all questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
| Q.1 | (a) Briefly explain the safety considerations in Process designing. | 03 |
| (b) What are GMPs? Why GMPs are to be followed in Pharmaceutical industries? | 04 | |
| (c) Describe in detail the factors influencing enzyme activity. | 07 | |
| Q.2 | (a) What are the classifications of raw materials? Briefly explain. | 03 |
| (b) Discuss fractional distillation as a purification method. | 04 | |
| (c) Explain the different types of Process validations. | 07 | |
| OR | ||
| (a) Describe two API syntheses in detail where use of PTC is advantageous. | 07 | |
| Q.3 | (a) Briefly explain the source of Enzymes. | 03 |
| (b) Define a reagent. List out the properties to be considered while selecting a reagent. | 04 | |
| (c) List out different types of documents required under GMP and discuss any three of them? | 07 | |
| OR | ||
| (a) Explain the Use of Calorimetry in addressing reaction safety. | 03 | |
| (b) Write a brief note on Marckwald principle & Reciprocal resolutions with example | 04 | |
| (c) Explain the techniques for identifying exotherm & gas evolution. | 07 | |
| Q.4 | (a) List out the factors in selecting a-solvent. | 03 |
| (b) Discuss Ultra filtration & microfiltration. | 04 | |
| (c) Discuss the importance of using solvents in detail | 07 | |
| OR | ||
| (a) List out the selection criteria for resolving agents. | 03 | |
| (b) Discuss rate of reaction with polarity. Illustrate with suitable examples | 04 | |
| (c) What are DQ, IQ, OQ, CQ & PQ and why are they required in Pharmaceutical industry as part of GMP ? | 07 | |
| Q.5 | (a) Write a note on super critical liquid as solvent | 03 |
| (b) Write a note on Simulated Bed Chromatography. Write its advantages. | 04 | |
| (c) Explain Michealis-Menton kinetics in enzyme catalysis. | 07 | |
| OR | ||
| (a) Briefly explain the classifications of separation process based on nature or physical mechanism of separation. | 03 | |
| (b) What is the principle of Chromatography?. Briefly explain column chromatography. | 04 | |
| (c) What are the principal factors to be considered when selecting filtration equipment. Briefly explain with diagram (1). Plate & Frame filters, (2). Rotary drum filter | 07 |
Total Marks: 70
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