Overview on Impurity Profiling

Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity. Impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. The control of impurities is currently a critical issue to the pharmaceutical industry. International Conference on Harmonization (ICH) formulated guidelines regarding the control of impurities. Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). Identification of impurities is done by TLC, HPLC, The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural elucidation of impurities as well. The most exploited techniques, for impurity profiling of drugs are LC-MS-MS, LC-NMR, LC-NMR- MS, GC-MS, and LC-MS.