Will you please give here syllabus for MS (Pharma ) Pharmaceutical Analysis course offered by NIPER Hyderabad?

As per your requirement I am here giving you syllabus for MS (Pharma ) Pharmaceutical Analysis course offered by NIPER Hyderabad.

NIPER Hyderabad MS (Pharma ) Pharmaceutical Analysis Syllabus:

I Semester
PA-510 Topics in Pharmaceutical Analysis :

1. Introduction to pharmaceutical analysis and techniques: Scope and range of modern
pharmaceutical analysis. Listing of various techniques, with broad discussion on their
applications.

2. Material and product specifications: Definition of specifications, study of Q6 guidelines and
understanding of specifications through study of pharmacopoeial monographs on drug
substances and products.

3. Reference standards: Types, preparation, containers, labeling, storage and use.

4. Documentation-STPs, certificate of analysis, laboratory books: Typical documents used in a
GLP laboratory including standard test protocols, COA and laboratory notebooks.

5. Introduction to method development: Method development concepts, steps involved, intricacies
at each step, use of software.

6. Methods validation: Definition and methodology, discussion on each parameter with examples.

7. Calibration and qualification of equipment: Difference of definitions, calibration standards,
calibration frequency, examples of calibration of pH meter, FTIR and a UV spectrophotometer.
Definition of qualification process involving DQ, IQ, OQ, CQ and PQ. Brief discussion on
protocol of each.

8. Bioanalysis and bioanalytical method validation: Types of body fluids, requirement of analysis,
matrix effects, sample preparation, non-biological analytical samples. Acceptance criteria in
comparison to non-biological samples.

9. Impurity profiling: Types of impurities in drug substances and products. Method
development for impurity analysis, techniques, identification and quantitation.

10. Automation and computer-aided analysis, LIMS: The concept of auto samplers and highthroughput
analysis, computer controlled instrumentation, and networked laboratory.
Peculiarities of laboratory information management systems (LIMS).

11. Management of analytical laboratory: Organization of laboratories based on their types, staffing,
skill development and training, budgeting and financing, purchase of costly equipment, qualities
of laboratory manager and management styles.

12. Laboratory inspections: Internal inspection, external audit, concepts, preparing for inspections
and audits.

(MS (Pharma ) Pharmaceutical Analysis :NIPER Hyderabad)






Address:
National Institute of Pharmaceutical Education and Research
Balanagar
Hyderabad, Telangana 500037

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