OU M.Pharm Question Papers Last 10 Years 2010-2020 || Osmania University
Code No: 6131/PCI
FACULTY OF PHARMACY
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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
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- Explain the guidelines for reporting and control of degradation products in new drug products. 10
- Explain the classifications of residual solvents and their limits in substances and drug products. 5
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- Describe the FDA/ICH guidelines for reporting levels of impurities in residual solvents. 10
- Write short note on qualification of degradation products. 5
- Write about:
- Control of elemental impurities 8
- Potential sources of elemental impurities. 7
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- Write about different analytical techniques used in characterization of degradants. 10
- What is impurity profiling and give its importance in testing of pharmaceutical products. 5
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- Write about HPTLC as finger printing tool in stability-testing of phytopharmaceuticals. 10
- What are accelerated stability studies and how do you calculate shelf life of drug products. 5
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- Write the principle and procedure and applications of radioimmunoassay. 10
- Write short note on optical Immunoassay. 5
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- Discuss the biological assay of diphtheria vaccine. 7
- Write the principle and procedure involved in bioassay of Human anti haemophilic vaccine. 8
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- Discuss the different polymerase chain reaction studies for gene expression. 8
- Explain the different steps involved in production of antibodies. 7
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