Impurity Profiling (Practical)

• The objectives of this course are:
• To understand the types and sources of impurities in pharmaceutical substances.
• To learn the techniques used for detection, isolation, and quantification of impurities.
• To study regulatory guidelines for impurity profiling (ICH, USFDA, EMA).
• To develop skills in interpreting impurity data and analytical validation.
• To apply impurity profiling in drug development, stability studies, and quality control.

After completion of the course student will be able to:

1. CO1Explain the principles and significance of impurity profiling in pharmaceutical analysis.
2. CO2Identify methods for detection and quantification of organic, inorganic, and residual impurities.
3. CO3Follow ICH and pharmacopeial guidelines for impurity limits and documentation.
4. CO4Perform impurity analysis using HPLC, GC, UV, and IR techniques.
5. CO5Evaluate and interpret impurity data for regulatory submissions and quality assurance.

1. Gorog, S. Impurities Evaluation of Pharmaceuticals. Marcel Dekker Inc., USA.
2. Teasdale, A. ICH Quality Guidelines: An Implementation Guide. John Wiley & Sons, USA.
3. Kar, A. Pharmaceutical Analysis. New Age International Publishers, New Delhi, India.
4. Connors, K. A. A Textbook of Pharmaceutical Analysis. Wiley India Pvt. Ltd., New Delhi, India.
5. Ahuja, S. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. Academic Press (Elsevier), USA.
6. Sethi, P. D. Quantitative Analysis of Drugs in Pharmaceutical Formulations. CBS Publishers & Distributors, New Delhi, India.
7. Chamberlain, J. The Analysis of Drugs in Biological Fluids. CRC Press, USA.