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- W1966102963 endingPage "173" @default.
- W1966102963 startingPage "148" @default.
- W1966102963 abstract "With ever increasing regulatory and compendial stringency on the control of impurities (IMPs) and degradation products (DPs) (including genotoxic impurities) in drug substances and finished pharmaceutical formulations, a profound emphasis is being paid on their characterization and analysis at trace levels. Fortunately, there have been parallel tremendous advancements in the instrumental techniques that allow rapid characterization of IMPs and/or DPs at the prescribed levels of ∼0.1%. With this, there is perceptible shift from conventional protocol of isolation and spectral analysis to on-line analysis using modern sophisticated hyphenated tools, like GC-MS, LC-MS, CE-MS, SFC-MS, LC-NMR, CE-NMR, LC-FTIR, etc. These are already being extensively used by industry and also there is tremendous increase in publications in the literature involving their use. This write-up critically reviews the literature for application of hyphenated tools in impurity and degradation product profiling of small molecules. A brief mention is made on possible pitfalls in the experimentation and data interpretation. Appropriate strategies are proposed, following which one can obtain unambiguous characterization of the unidentified IMPs and/or DPs." @default.
- W1966102963 created "2016-06-24" @default.
- W1966102963 creator A5009782782 @default.
- W1966102963 creator A5009899761 @default.
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- W1966102963 creator A5034924972 @default.
- W1966102963 creator A5065184722 @default.
- W1966102963 creator A5085708287 @default.
- W1966102963 date "2012-10-01" @default.
- W1966102963 modified "2023-10-04" @default.
- W1966102963 title "A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products" @default.
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