Download OU M.Pharma Ph.Analysis 1st Sem 2019 13160 PCI Advanced Pharmaceutical Analysis Question Paper

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Code No. 13160/ PCI

FACULTY OF PHARMACY

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M. Pharmacy (Phar.Analysi.) I - Semester (PCI) (Main & Backlog) Examination, January 2019

Subject: Advanced Pharmaceutical Analysis

Time: 3 Hrs Max.Marks: 75

Note: Answer any five questions. All questions carry equal marks.

1. a) Define Impurity and give the classification of impurities in new drug substances. 5
   

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   b) Explain the guidelines for reporting and control of elemental impurities in new drug products. 10
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.
3. a) Explain the factors affecting stability of drug substance and drug products. 10
   b) How do you perform photo stability of formulations?

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4. a) Write about different analytical techniques used in characterization of degradants. 10
   b) What is impurity profiling and give its importance in testing of pharmaceutical products. 5
5. a) Write about HPTLC as finger printing tool in stability testing of phytopharmaceuticals. 10
   b) What are accelerated stability studies and how do you calculate shelf life of drug products. 5
6. Write about the following
   

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   a) Enzyme immunoassay
   b) Optical Immunoassay
7. a) Describe the principle and procedure involved in the biological assay of oxytocin.
   b) What are antitoxins? Give biological assay of Tetanus antitoxin.
8. a) Discuss the different polymerase chain reaction studies for gene expression.
   

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   b) Explain the different steps involved in production of antibodies.