Importance of Impurity Profiling Regulatory Compliance in Pharma | Dr. Archana Bahuguna | CSI

There is an ever-increasing interest in impurities present in APIs. Nowadays, not only purity profile but also impurity profile has become mandatory according to various regulatory authorities. In the pharmaceutical world, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arise out of synthesis or unwanted chemicals that remain with APIs. Impurity profiling includes identification, structure elucidation, and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. Impurity profiling has gained importance in modern pharmaceutical analysis because unidentified, potentially toxic impurities are hazardous to health and in order to increase the safety of drug therapy, impurities should be identified and determined by selective methods. Terms such as residual solvents, byproduct, transformation products, degradation products, interaction products, and related products are frequently used to define impurities. The control of impurities in Formulated Products and Active Pharmaceutical ingredients were regulated by various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). Identification of impurities is done by a variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. There are different methods for detecting and characterizing impurities with TLC, HPLC, HPTLC, AAS, etc. Impurity profiling study has been in the limelight in the recent pharmaceutical scenario and its importance is increasing day by day.
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[@achyutjagdhane9683]

thanks a lot madam , its a beautiful session, got a clarity on compliance , thanks

[@aa29854]

Thi session is dedicated in the loving memory of my Research Guide Prof Dr R T Sane

[@SG73088]

Prof. R T sane was great professor in Analytical chemistry area in India.

[@SG73088]

Fantastic lecture. Thank you madam.

[@aa29854]

Thanks for listening to the session and for the appreciation.

[@SG73088]

@@aa29854 Madam, Please take lecture on Preparative HPLC chromatography topic .