Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code:2920104 Date: 17/11/2018
Subject Name: Modern Pharmaceutical Analysis
Time:02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Explain in detail the amino acid sequence analysis.
06

What is isoelectric focusing? Explain the application of isoelectric focusing in pharmaceutical analysis.
05

Write a short note on tryptic mapping.
05
Q.2

Write in brief the regulatory requirements of drug analysis as per US FDA guidelines.
06

Explain the sterility testing of Parentral products.
05

Define solubility and write any two methods for determination of solubility of solid in liquid.
05
Q.3

Explain the importance of pre-formulation studies. Write in detail about pharmaceutical and mechanical properties in pre-formulation studies.
06

Write a short note on regulatory requirements of cosmetic products.
05

Write in brief about the compendial methods for evaluation of crude drugs.
05
Q.4

Write a short note on classification and determination of residual solvents in API, in accordance to ICH guidelines.
06

Explain in detail the concept of automated analysis.
05

Write a note on radiochemical methods in analysis of pharmaceuticals.
05
Q.5

What is the effect of impurity in API? Write a short note on degradation study.
06

Explain the validation of assay methods as per the ICH guidelines.
05

Describe the application of near IR in physicochemical characterization of solid dosage forms.
05
Q. 6

Explain the bio-burden testing of parentral products.
06

Write a note on quality control of radiopharmaceuticals.
05

Explain methods for analysis of cosmetics.
05
Q.7

Write a brief note on isolation and identification of impurities.
06

How will you determine solubility and dissociation constant of new drug substances.
05

Describe the IP method for validation of UV Spectrophotometer.
05