Download OU M.Pharma Ph.Analysis 1st Sem 2018 1151PCI Advanced Pharmaceutical Analysis Question Paper

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Code No. 1151/PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharma. Analysis) I-Semester (PCI) (Main) Examination, February 2018

Subject: Advanced Pharmaceutical Analysis

Time: 3 Hrs Max. Marks: 75

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

1. (a) Explain in-detail about impurity profiling of new drug product. (10)
   

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   (b) Write classification and identification of elemental impurities. (5)
2. (a) Explain briefly protocol adopted for stability testing of drugs. (8)
   (b) Describe briefly accelerated stability studies and determination of shelf-life. (7)
3. (a) Explain various principles and testing procedures involved in degradant characterization. (8)
   (b) Describe ICH stability guidelines for biological products. (7)

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4. (a) Write an account on requirements for stability testing of phytopharmaceuticals. (7)
   (b) Describe the principle and methods involved in HPLC finger printing with suitable examples. (8)
5. (a) Mention different types of tetanus vaccine. Explain bioassay of adsorbed tetanus vaccine. (8)
   (b) Describe the principle and procedure involved in bioassay of any one biological product. (7)
6. (a) Describe the principle, instrumentation and applications of radio immune assay. (8)
   

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   (b) Describe procedures for separation of bound and unbound drug during immunoassay. (7)
7. (a) Write an account on elemental impurities and their determination. (10)
   (b) Explain basic principle and applications of PCR studies. (5)
8. (a) Write classification, potential sources, control and identification of residual solvent impurities. (10)
   (b) Describe the production of antibodies. (5)

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