Download GTU (Gujarat Technological University) BE/BTech (Bachelor of Engineering / Bachelor of Technology) 2018 Winter 7th Sem New 2173602 Process Technology Of Drugs And Intermediates Previous Question Paper
Seat No.: ________ Enrolment No.___________
GUJARAT TECHNOLOGICAL UNIVERSITY
BE - SEMESTER ?VII (NEW) EXAMINATION ? WINTER 2018
Subject Code: 2173602 Date: 15/11/2018
Subject Name: Process Technology of Drugs & Intermediates
Time: 10:30 AM TO 01:00 PM Total Marks: 70
Instructions:
1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
MARKS
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
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
(c) Describe with suitable neat diagrams: (a). Column Chromatography, (b).
Ion exchange Chromatography, (c).Gel filtration chromatography
07
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
(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
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
(b) Define ?Residual Solvents? in drug substance. Briefly discuss the
classifications of residual solvent by risk assessment.
04
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1
Seat No.: ________ Enrolment No.___________
GUJARAT TECHNOLOGICAL UNIVERSITY
BE - SEMESTER ?VII (NEW) EXAMINATION ? WINTER 2018
Subject Code: 2173602 Date: 15/11/2018
Subject Name: Process Technology of Drugs & Intermediates
Time: 10:30 AM TO 01:00 PM Total Marks: 70
Instructions:
1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
MARKS
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
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
(c) Describe with suitable neat diagrams: (a). Column Chromatography, (b).
Ion exchange Chromatography, (c).Gel filtration chromatography
07
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
(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
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
(b) Define ?Residual Solvents? in drug substance. Briefly discuss the
classifications of residual solvent by risk assessment.
04
2
(c) Define?Qualification?. Explain the different types of qulifications and their
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
(c) Define ?Validation?. Explain the different types of Process validations.
What are the types of validation documents?
07
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This post was last modified on 20 February 2020