Exam Details

Subject advanced pharmaceutical analysis
Paper
Exam / Course m.pharm
Department
Organization G. Pulla Reddy College Of Pharmacy
Position
Exam Date January, 2019
City, State telangana, hyderabad


Question Paper

FACULTY OF PHARMACY
M. Pharmacy (Phar.Analysi.) I Semester (Main Backlog) Examination,
January 2019
Subject: Advanced Pharmaceutical Analysis
Time: 3 Hours Max.Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Define Impurity and give the classification of impurities in new drug substances. 5
Explain the guidelines for reporting and control of elemental impurities in new drug
products. 10
2 Describe the FDA/ICH guidelines for reporting levels of impurities in residual
solvents. 10
Write short note on qualification of degradation products. 5
3 Explain the factors affecting stability of drug substance and drug products. 10
How do you perform photo stability of formulations? 5
4 Write about different analytical techniques used in characterization of degradants. 10
What is impurity profiling and give its importance in testing of pharmaceutical
products. 5
5 Write about HPTLC as finger printing tool in stability testing of phytopharma
ceuticals. 10
What are accelerated stability studies and how do you calculate shelf life of drug
products. 5
6 Write about the following
Enzyme immunoassay 8
Optical Immunoassay 7
7 Describe the principle and procedure involved in the biological assay of oxytocin. 8
What are antitoxins? Give biological assay of Tetanus antitoxin. 7
8 Discuss the different polymerase chain reaction studies for gene expression. 8
Explain the different steps involved in production of antibodies. 7


Subjects

  • advanced pharmaceutical analysis
  • food analysis
  • modern pharmaceutical analytical techniques
  • pharmaceutical validation