ISOLATION OF PHARMACEUTICAL IMPURITIES FROM BULK DRUG PREPARATIONSJournal: International Journal of Advanced Research (Vol.8, No. 6)
Publication Date: 2020-07-17
Authors : Promila Thakur;
Page : 1436-1444
Keywords : Impurity ICH Requirements Classification of Impurity Isolation Case Study of Cabozantinib Tablets;
This article is basically based on the idea that how to identify and isolate the pharmaceutical impurities present in Active pharmaceutical ingredients (API). Generally, the impurities present in API are isolated by various Chromatographic and Non-Chromatographic method based on the nature of impurities. According to the regulatory guidelines some impurities even in trace amount/ small amount is unavoidable and there is a necessity to control them if the level of identified impurity is greater than the threshold impurities but if the identified impurity is less than the threshold impurities, we can neglect it. After the isolation and identification of impurities we characterize them by using several techniques Like NMR (Nuclear magnetic resonance), LC-MS (Liquid chromatography coupled to mass spectrometry) and etc.
Other Latest Articles
Last modified: 2020-07-18 19:18:43