Download OU M.Pharma Ph.Analysis 1st Sem 2019 6131PCI Advanced Pharmaceutical Analysis Question Paper

Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2019 6131PCI Advanced Pharmaceutical Analysis Previous Question Paper

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Code No: 6131/PCI
M. Pharmacy (Phar. Analysis) I-Semester (PCI) (Main & Backlog) Examination,
February 2019
Subject: Advanced Pharmaceutical analysis
Time: 3 hrs Max. Marks: 75
Note: Answer any five Questions. All Questions carry Equal Marks
1 a) Explain the guidelines for reporting and control of degradation products in new
drug products. 10
b) Explain the classifications of residual solvents and their limits in substances and
drug products. 5

2 a) Describe the FDA/ICH guidelines for reporting levels of impurities in residual
solvents. 10
b) Write short note on qualification of degradation products. 5

3 Write abt :
a) Control of elemental impurities 8
b) Potential srces of elemental impurities. 7

4 a) Write abt different analytical techniques used in characterization of degradan ts. 10
b) What is impurity profiling and give its importance in testing of pharmaceutical
products. 5

5 a) Write abt HPTLC as finger printing tool in stability testing of phytopharmaceuticals.10
b) What are accelerated stability studies and how do y calculate shelf life of drug
products. 5

6 a) Write the principle and procedure and applications of radioimmunoassay. 10
b) Write short note on optical Immunoassay. 5

7 a) Discuss the biological assay of diphtheria vaccine. 7
b) Write the principle and procedure involved in bioassay of Human anti haemophilic
vaccine. 8

8 a) Discuss the different polymerase chain reaction studies for gene expression. 8
b) Explain the different steps involved in production of antibodies. 7

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This post was last modified on 19 July 2020