FirstRajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - MAY 2016
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[Time: 3 Hours] [Max. Marks: 100]
Analytical Assurance
(Revised Scheme 4)
Q.P. CODE: 9363
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- What are Stability Indicating Assay Methods (SIAM)? Discuss the methodology for development and validation of SIAM.
- Write the production, chemistry and properties of Bacterial Pyrogens and Endotoxins.
- Explain in detail the various ICH guidelines for validation of LC method.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Discuss the WHO guidelines for standardization of Herbal drugs.
- Explain the different sources and types of impurities.
- Write the Principle, Methodology and Applications of ELISA.
- Explain in detail the Qualification of UV-Visible spectrometer.
- Discuss the statistical principles involved in bioassay.
- Explain the USP Methodology for testing Preservative Efficacy.
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SHORT NOTES 2 X 5 = 10 Marks
- GC-MS
- Applications of Near IR Spectroscopy
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