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

Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2019 13160 PCI Advanced Pharmaceutical Analysis Previous Question Paper

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Code No. 13160 / PCI
FACULTY OF PHARMACY
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
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. 5
3 a) Explain the factors affecting stability of drug substance and drug products. 10
b) How do y perform photo stability of formulations? 5
4 a) Write abt differe nt 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 abt HPTLC as finger printing tool in stability te sting of phytopharma
ceuticals. 10
b) What are accelerated stability studies and how do y calculate shelf life of drug
products. 5
6 Write abt the following
a) Enzyme immunoassay 8
b) Optical Immunoassay 7
7 a) Describe the principle and procedure involved in the biological assay of oxytocin. 8
b) What are antitoxins? Give biological assay of Tetanus antitoxin. 7
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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