Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2016 November (Master of Pharmacy) 1st Year 9363 Analytical Assurance Revised Scheme 4 Previous Question Paper

Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - NOV 2016
[Time: 3 Hours]
[Max. Marks: 100]
Analytical Assurance
(Revised Scheme 4)
Q.P. CODE: 9363
Your answers should be specific to the questions asked.
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)
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).
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.
11.
What is High Through Put Screening? Explain briefly.
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