Download GTU BE/B.Tech 2019 Winter 7th Sem New 2173602 Process Technology Of Drugs And Intermediates Question Paper

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Subject Code: 2173602

GUJARAT TECHNOLOGICAL UNIVERSITY

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BE - SEMESTER- VII (New) EXAMINATION — WINTER 2019

Subject Name: Process Technology of Drugs & Intermediates

Date: 23/11/2019

Time: 10:30 AM TO 01:00 PM

Total Marks: 70

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Instructions:

1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1

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1. Define Process safety. Briefly explain the types of hazards [03]
2. Describe Simulated Bed Chromatography with a schematic diagram. [04]
3. Describe the resolution of Racemates by (1). Direct crystallization method, (2). Preferential crystallization method with example and schematic diagrams. [07]

Q.2

1. Why Good manufacturing Practices (GMP) are to be followed in Pharma Industries? Where these guide lines are applicable? What are the importance of GMP [03]

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2. Describe the steps which are to be taken for optimizing reactions [04]
3. Briefly discuss the techniques for identifying exothermicity & gas generation. Illustrate the use of calorimetry with three examples. [07]

   OR

4. Discuss about (1). Choosing a Phase transfer catalyst (PTC), (2). How selectivity in PTC can be achieved. Illustrate the advantages of using PTC in any two organic synthesis [07]

Q.3

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1. Why enzymes are preferred as catalyst? Describe the regulation of enzymes [03]
2. Define Chiral auxiliary. With a schematic diagram, illustrate the use of Chemical Auxillary. Give one example of the use of Chiral auxillary [04]
3. What are the factors to be considered while choosing a solvent. Briefly describe them. [07]

   OR

Q.3

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1. Discuss about Marckwald principle & Reciprocal resolution with example [03]
2. Discuss “Residual solvents”. Write a note on classification of solvents by risk assessment. [04]
3. Describe, (1). Adulterated drug, (2). Deviation investigation, (3). CAPA [07]

Q.4

1. Write a note on Supercritical liquid as solvent [03]

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2. Discuss the steps to be taken for optimizing the mesylation of Propargylic alcohol [04]
3. Write a note on classifications of Enzymes. Discuss in detail the Lipases & Esterases and their catalytic reactions. [07]

   OR

Q.4

1. Write a note on Enzymes & their sources. [03]

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2. Define “Reagent”. List out the factors to be considered while selecting reagent. [04]
3. Explain in detail the factors affecting the enzyme activity [07]

Q.5

1. Briefly describe Adsorption & factors affecting adsorption. [03]
2. Explain in detail Chromatography as a separation technique. [04]

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3. Describe (1). cGMP violations (2). Qualifications in GMP [07]

   OR

Q.5

1. What are the principle factors to be considered while selecting filtration equipment. Explain the working of rotary drum filter & leaf filter with a suitable diagram. [04]
2. Why documentation is important in GMP? List out the important documents required under GMP. Write detailed notes on Process validation. [07]

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