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  • Title: Critical practical aspects in the application of liquid chromatography-mass spectrometric studies for the characterization of impurities and degradation products.
    Author: Narayanam M, Handa T, Sharma P, Jhajra S, Muthe PK, Dappili PK, Shah RP, Singh S.
    Journal: J Pharm Biomed Anal; 2014 Jan; 87():191-217. PubMed ID: 23706957.
    Abstract:
    Liquid chromatography-mass spectrometry (LC-MS) is considered today as a mainstay tool for the structure characterization of minor components like impurities (IMPs) and degradation products (DPs) in drug substances and products. A multi-step systematic strategy for the purpose involves high resolution mass and multi-stage mass studies on both the drug and IMPs/DPs, followed by comparison of their fragmentation profiles. Its successful application requires consideration of many practical aspects at each step. The same are critically discussed in this review.
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