Institute of Pharmacy

PHARMACOPOEIAL METHODS OF ANALYSIS ( 3PA204 )


Course Code : 3PA204 Semester : 2 Credit : 5.00
Lectures/week : 3 Practicals/week : 3 Tutorials/week : -
Exam Weightage Exam Hours
CE LP SEE SEE PRE
0.40 0.20 0.40 - -
 

Learning Outcomes

  1. Students are able to understand the basic analytical methodology used for biotech products.
  2. Students learns the applicability of analytical methods for biotech products.
  3. Students understands various aspects like identification test, purity test, assays, bioassays, limit test by case study of biotech products as per pharmacopoeia as well as able to differentiate it with conventional dosage forms

Syllabus


Scope of biotechnology in the development of Pharmacopoeial articles.

Analytical methodology for biotechnology derived products

• Amino Acid analysis • Protein sequencing • Peptide mapping • Immuno assays • Electrophoresis • Quantitative assays

Stability testing of Biotech/ biological products

Case study of Analysis of some biotechnology derived products like Interferon Alfa-2 concentrated so

Limit tests

Biological methods

• Efficacy of antimicrobial preservatives • Bacterial endotoxins • Pyrogens • Microbial contamination • Microbiological assay of antibiotics • Sterility • Tests for CFUMiscellaneous tests • Tests for Vaccines • Tests for Blood and Blood related products

References