Degradation and characterization of impurities of new drug candidate using advance analytical techniques
Sanjay Sharma
NKBR College of Pharmacy and Research Centre, India
: J Diagnos Tech Biomed Anal
Abstract
One of the most important considerations in the drug discovery process is safety, not only of the drug itself, but also impurities and degradation products. Impurities present in the API have to be identified to make sure no mutagenic or toxic substances will be administered to patients. Drug product degradation profiles need to be established to guide stable formulation and provide suitable drug shelf life assessment. Drug regulatory agencies also have requirements for characterization of the impurity profile of a pharmaceutical. Structural characterization of impurities and degradation products in bulk drug substances is an integral part of pharmaceutical product development. The analysis of these low level unknown impurities and degradants can be very challenging. 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). Impurity and degradant structure elucidation is a collaborative effort involving the analytical chemist, and/or formulation as well as experts in degradation, mass spectrometry, and nuclear magnetic resonance. Identification of the degradation sample set leads to understating of degradation mechanism. In present scenario, advancement in the conventional instrumental techniques are fast characterization of impurities and related substances/ degradation products spectral analysis and isolation, using new analytical techniques, like UPLC, LC-MS, GC-MS, SFC-MS, LCNMR, CE-MS etc. The conventional technique included separation and identification of impurities or related substances (RS) by suitable method. Eventually they are isolated and followed by characterization using various spectroscopic techniques. The new advance concept is their characterization by the use advance analytical techniques.
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