Dipankar Nath* and Bidhya Sharma Pages 1 - 11 ( 11 )
There has been ever increasing interest in impurities present in Active Pharmaceutical Ingredient’s (API’s). Nowadays, not only purity profile but also impurity profile has become mandatory according to the various regulatory authorities. In the pharmaceutical world, an impurity is considered as an inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arising out of synthesis or unwanted chemicals that remains with APIs. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulation. The control of impurities in Formulated products and API’s were regulated by various regulatory authorities like ICH, USFDA, Canadian Drug, and Health Agency. Impurity profiling is very important in the modern pharmaceutical analysis due to the fact that 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 the selective method. Nowadays, it is a mandatory requirement in various pharmacopeias to know the impurities present in APIs and finished drug products. Thus, impurity profiling can act as a Quality Control tool. It can provide crucial data regarding the toxicity, safety, various limits of detection and limits of quantitation of several organic and inorganic impurities, usually accompany with APIs and finished products. There is a strong requirement to have unique specifications/standards with regard to impurities.
Drugs, Impurity profiling, Safety, Analysis.ICH Guidelines
Himalayan Pharmacy Institute, Majhitar, East Sikkim, Himalayan Pharmacy Institute, Majhitar, East Sikkim