Exam Details
Subject | advanced pharmaceutical analysis | |
Paper | ||
Exam / Course | m.pharm | |
Department | ||
Organization | G. Pulla Reddy College Of Pharmacy | |
Position | ||
Exam Date | August, 2018 | |
City, State | telangana, hyderabad |
Question Paper
FACULTY OF PHARMACY
M. Pharmacy (Pharma. Analysis) I-Semester (Supple.) Examination,
August 2018
Subject: Advanced Pharmaceutical Analysis
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Define impurity and write classification of impurities in drug substances with
examples.
Describe analytical procedures for quantification of impurities in drug products
As per ICH guidelines and mention their threshold limits.
2 Classify and write the potential sources of elemental impurities.
Describe instrumentation and analytical procedures for analysis of carbon,
hydrogen, nitrogen and sulphur impurities.
3 Write the systematic approach to stability evaluation of drug substances.
Explain the influence of temperature, pH buffering species ionic strength
and dielectric constant on drug stability.
4 Write an account on WHO and ICH guidelines for stability testing.
5 Explain the role of analytical instruments (HPTLC HPLC) in interaction
and complexity studies of phytopharmaceuticals.
Write a note on stability testing protocols for herbal drugs.
6 Define bioassay. Describe the principle and method involved in bioassay of
any one biological product.
What are antitoxins? Give biological assay of tetanus antitoxin.
7 Describe basic principles of radio immune assay. Enumerate its applications
and limitations.
Describe the production of antibodies.
8 Write an account on Impurity profiling and degradation product characterization
studies for gene regulation.
Classify residual solvents by risk assessment and describe their limits.
M. Pharmacy (Pharma. Analysis) I-Semester (Supple.) Examination,
August 2018
Subject: Advanced Pharmaceutical Analysis
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Define impurity and write classification of impurities in drug substances with
examples.
Describe analytical procedures for quantification of impurities in drug products
As per ICH guidelines and mention their threshold limits.
2 Classify and write the potential sources of elemental impurities.
Describe instrumentation and analytical procedures for analysis of carbon,
hydrogen, nitrogen and sulphur impurities.
3 Write the systematic approach to stability evaluation of drug substances.
Explain the influence of temperature, pH buffering species ionic strength
and dielectric constant on drug stability.
4 Write an account on WHO and ICH guidelines for stability testing.
5 Explain the role of analytical instruments (HPTLC HPLC) in interaction
and complexity studies of phytopharmaceuticals.
Write a note on stability testing protocols for herbal drugs.
6 Define bioassay. Describe the principle and method involved in bioassay of
any one biological product.
What are antitoxins? Give biological assay of tetanus antitoxin.
7 Describe basic principles of radio immune assay. Enumerate its applications
and limitations.
Describe the production of antibodies.
8 Write an account on Impurity profiling and degradation product characterization
studies for gene regulation.
Classify residual solvents by risk assessment and describe their limits.
Other Question Papers
Subjects
- advanced pharmaceutical analysis
- food analysis
- modern pharmaceutical analytical techniques
- pharmaceutical validation