Subject Code: 2173602
GUJARAT TECHNOLOGICAL UNIVERSITY
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BE - SEMESTER-VII (NEW) EXAMINATION - WINTER 2018Subject Name: Process Technology of Drugs & Intermediates
Time: 10:30 AM TO 01:00 PM
Instructions:
- Attempt all questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
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Q.1 (a) Write a brief account on “Regulation of Enzyme activity” [03]
(b) List out the steps for optimization of process. Describe any two steps with suitable example. [04]
(c) List out the different types of documents to be maintained in GMP. Describe any four of them in detail. [07]
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Q.2 (a) List out the factors to be considered while choosing a Phase Transfer Catalyst (PTC) & how selectivity in PTC can be achieved? [03]
(b) Define “Process Safety”. Briefly discuss the types of hazard to be considered from reactivity of compounds. [04]
(c) List out the factors to be considered when selecting filtration equipment. Describe any two filtration equipment with neat diagrams. [07]
OR
Q.2 (c) Describe with suitable neat diagrams: (a). Column Chromatography, (b). Ion exchange Chromatography, (c).Gel filtration chromatography [07]
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Q.3 (a) Briefly discuss the Process safety failure consequences. [03]
(b) Write a note on Simulated Bed Chromatography. What are its advantages? [04]
(c) Describe the factors influencing the enzyme activity. [07]
OR
Q.3 (a) Discuss Ultra filtration & Microfiltration [03]
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(b) Define Adsorption. Discuss briefly about the factors affecting adsorption. [04](c) What are the classifications of Enzymes? Write in detail about Lipases & Esterases with suitable examples of reactions catalyzed by them. [07]
Q.4 (a) Define “Adulterated Drug”. Write a note on the importance of GMP in Pharmaceutical industries. [03]
(b) Write a brief note on Marckwald principle & Reciprocal resolutions with example [04]
(c) Briefly explain the techniques for identifying exotherm & gas generation. Describe with two suitable examples for the Calorimetry use in designing safe scale up process. [07]
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OR
Q.4 (a) Write a note on super critical liquid as solvent [03]
(b) What is a “reagent”? Discuss the properties to be considered while selecting a reagent. [04]
(c) Describe two methods of resolution of racemates by direct crystallization with suitable examples. [07]
Q.5 (a) What are the requirements of Chiral auxillaries? Write the schematic representation of the use of Chiral Auxillary. [03]
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(b) Define “Residual Solvents” in drug substance. Briefly discuss the classifications of residual solvent by risk assessment. [04](c) What is Qualification need in Pharmaceutical industries. List out the important contents in Qualification protocol. [07]
OR
Q.5 (a) What are the selection criteria for resolving agents. Give one example of the use of resolving agent. [03]
(b) List out the factors in choosing a solvent. Explain any two factors in detail. [04]
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(c) Define “Validation”. Explain the different types of Process validations. What are the types of validation documents? [07]Date: 15/11/2018
Total Marks: 70
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