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.
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Author Name: Promila Thakur
URL: View PDF
Keywords: Impurity ICH Requirements Classification of Impurity Isolation Case Study of Cabozantinib Tablets
ISSN: 2320-5407
EISSN: 2320-5407
EOI/DOI: 10.21474/IJAR01/11232
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