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Degradation And Characterization Of Impurities Of New Drug Candidate Using Advance Analytical Techniques | 34634
ISSN: 2155-9872
Journal of Analytical & Bioanalytical Techniques
Open Access
Our Group organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.
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.