Download RGUHS M.Pharmacy First Year Nov 2016 9363 Analytical Assurance Revised Scheme 4 Question Paper

Rajiv Gandhi University of Health Sciences

FirstRanker.com

First Year M. Pharm Degree Examination - NOV 2016

--- Content provided by‌ FirstRanker.com ---

[Time: 3 Hours] [Max. Marks: 100]

Analytical Assurance

(Revised Scheme 4)

Q.P. CODE: 9363

Your answers should be specific to the questions asked.

--- Content provided by‌ FirstRanker.com ---

Draw neat, labeled diagrams wherever necessary.

LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks

1. Write a note on Validation of an Analytical method as per ICH E6 guidelines.
2. a) Explain different types of Stability Analysis in Bioanalytical method Validation along with their relevance.
   b) Differentiate Herbal Substances, preparations and products. (15+5)

--- Content provided by FirstRanker.com ---

3. Write a note on Residual Solvents identification, characterization and quantification by LC-MS/MS.

SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks

4. What are Forced Degradation Studies? Why and how are they performed?
5. Compare and contrast EU and WHO requirements for Herbal Products.
6. Explain the principle, advantages and disadvantages of RIA (Radio Immuno Assay).

--- Content provided by​ FirstRanker.com ---

7. Write a note on Statistics used in Bioassay.
8. How Antimicrobial Effectiveness Testing is performed as per USP?
9. How is the Performance Qualification of a HPLC done?

SHORT NOTES 2 X 5 = 10 Marks

10. Enlist the Production and Research Applications of NIR (Near Infra Red) Spectroscopy.

--- Content provided by⁠ FirstRanker.com ---

11. What is High Through Put Screening? Explain briefly.

*****

FirstRanker.com