Eminent University of Health Sciences
First Year M Pharm Degree Examination - December 16
[Time: 3 Hours] [Max. Marks: 100]
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Pharmaceutical Technology and Validation
(Revised Scheme 4)
Q.P. CODE: 9362
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- What are the objectives of IVIVC? Describe different levels of correlation for IVIVC.
- Explain the procedure for determining the solubility of an API. Describe different techniques of increasing the solubility of a sparingly soluble drug. Compare their merits and demerits.
- Explain the different approaches to CLV and fixing their acceptance criteria.
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
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- List and explain the ICH guidelines associated with stability testing.
- What is polymorphism? What is its significance in dissolution? Name the methods to identify polymorphs.
- Bracketing and Matrixing in stability studies
- How will you perform HEPA filter leak test (DOP), give its significance.
- Criteria for granting biowaivers and their significance
- Qualification of Sterilization Tunnel
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SHORT NOTES 2 X 5 = 10 Marks
- BACPAC
- How will you sample particulate matters in clean rooms?
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This download link is referred from the post: RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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