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Rajiv Gandhi University of Health Sciences, Karnataka
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First Year M. Pharm Degree Examination – Oct/Nov 2014
Time: Three Hours
Max. Marks: 100 Marks
ANALYTICAL ASSURANCE
(Revised Scheme 4)
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Q.P. CODE: 9363
Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary
LONG ESSAYS (Answer any Two)
2 x 20 = 40 Marks
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- Write different types of bioassay and explain statistical principle used in bioassay.
- Describe the standardization of herbal substance with special emphasis on microbial, heavy metals and pesticide residues.
- Write validation of analytical methods, as per ICH guidelines and USP.
SHORT ESSAYS (Answer any FIVE)
5 x 10 = 50 Marks
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- Describe qualification of UV- Visible spectrophotometer.
- Write in detail on preservative efficacy testing as per USP.
- Explain the types & sources of impurities & validation procedure for the same.
- Write notes on membrane filtration methods limit test?
- Describe the application of near infra red spectroscopy.
- Write details about accuracy and precision for analytical method validation.
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SHORT NOTES
2 x 5 = 10 Marks
- Write about High-throughput screening.
- Explain the principle of sandwich ELISA.
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