RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
First Year M. Pharmacy Degree Examination
[Time: 3 Hours] [Max. Marks: 100]
Analytical Assurance
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(Revised Scheme 4)
Q.P. CODE: 9363
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary. Answer any ten questions.
LONG ESSAY (Answer any TEN) 10 X 10 = 100 Marks
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- Explain in detail the WHO requirements for the standardization of Herbal substances, preparations and products.
- Explain the concepts of a) Accuracy and b) Precision in an analytical method.
- What are the factors to be considered during sample preparation for HPLC analysis of drug products? What is Phase appropriate method development?
- What is Performance Verification? Explain the terms: Design Qualification, Installation Qualification and Operational Qualification?
- Explain in detail sterility testing methodology of pharmaceutical products as per IP requirements.
- Discuss the chemistry and concept and chemistry of Bacterial Endotoxin testing of sterile products.
- Explain the concept of ELISA and its application as the diagnostic test for HIV.
- Explain briefly on statistical approaches in Bioassay. How do you estimate of safe doses?
- Explain in detail application of Near Infra-Red spectroscopy in pharmaceutical manufacturing.
- Enumerate and elaborate different steps for Stability Indicating Assay Methods (SIAM).
- Explain preservative efficacy or antimicrobial effectiveness testing as per USP.
- How do you set limits for residual solvents in drug substance as per ICH Q3 guidelines?
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