Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2018 1302PCI Advanced Pharmaceutical Analysis Previous Question Paper
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Code No. 1302/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharma. Analysis) I-Semester (PCI) (Supple.) Examination,
August 2018
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 write classification of impurities in drug substances with
examples. (5)
(b) Describe analytical procedures for quantification of impurities in drug products
As per ICH guidelines and mention their threshold limits. (10)
2 (a) Classify and write the potential srces of elemental impurities. (5)
(b) Describe instrumentation and analytical procedures for analysis of carbon,
hydrogen, nitrogen and sulphur impurities. (10)
3 (a) Write the systematic approach to stability evaluation of drug substances. (8)
(b) Explain the influence of temperature, pH buffering species ionic strength
and dielectric constant on drug stability. (7)
4 Write an accnt on WHO and ICH guidelines for stability testing. (15)
5 (a) Explain the role of analytical instruments (HPTLC & HPLC) in interaction
and complexity studies of phytopharmaceuticals. (10)
(b) Write a note on stability testing protocols for herbal drugs. (5)
6 (a) Define bioassay. Describe the principle and method involved in bioassay of
any one biological product. (8)
(b) What are antitoxins? Give biological assay of tetanus antitoxin. (7)
7 (a) Describe basic principles of radio immune assay. Enumerate its applications
and limitations. (10)
(b) Describe the production of antibodies. (5)
8 (a) Write an accnt on Impurity profi ling and degradation product characterization
studies for gene regulation. (10)
(b) Classify residual solvents by risk assessment and describe their limits. (5)
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This post was last modified on 19 July 2020