First Year M. Pharmacy Examination FirstRanker.com
[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 the validation of analytical method by LC as per ICH guidelines.
- Discuss in detail the identification and characterization of impurities by AAS/ICPMS.
- Explain the harmonized methods for microbiological limit test.
- Discuss the sample preparation and validation parameters for bio-analytical method as per USFDA guidelines.
- Explain the different steps involved in development and validation of SIAM.
- Explain the WHO requirements for standardization of herbal substances and herbal products.
- Discuss in detail different types of ELISA methods.
- Explain Primary bioassay screening and high through put screening.
- Explain in detail the concept and chemistry of bacterial endotoxin test for sterile products.
- Discuss the similarities and differences in principles of SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscopy).
- Discuss the parameters for qualification of GC.
- Explain preservative efficacy testing procedure as per USP.
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