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Rajiv Gandhi University of Health Sciences
First Year M.Pharm Degree Examination – Nov 2011
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[Time: 3 Hours] [Max. Marks: 100]
CHEMICAL AND BIOLOGICAL EVALUATION
PAPER IV
(RS 2 & RS 3)
Q.P. CODE: 9224
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Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- What is method validation? Explain the parameters determined for validating an analytical method
- Give the principle and methods involved in the bioassay of any three hormone preparations
- Give an account of the various factors that are to be considered for the layout, environment and water supplies and others for the establishment of a pharmaceutical manufacturing unit
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Write a note on sterility testing and interpellation in a formulation unit
- Give the procedures for the assay of diphtheria and Tetanus vaccines
- Explain how computers are useful in a quality control laboratory
- Give the SOP for a HPLC instrument
- How do you determine the effectiveness of an antimicrobial preservative
- Discuss in detail about salvaging of returned goods and reprocessing
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SHORT NOTES 2 X 5 = 10 Marks
- Give the method of microbial assay of vitamin B12
- How do you test a parenteral preparation for the presence of pyrogens
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