Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances

The assessment and control of genotoxic impurities (GTI) in pharmaceutical products has received considerable attention in recent years. Molecular functional groups that render starting materials and synthetic intermediates useful as reactive building blocks for small molecules may also be responsib...

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Veröffentlicht in:	Organic process research & development 2009-03, Vol.13 (2), p.285-291
Hauptverfasser:	Pierson, Duane A, Olsen, Bernard A, Robbins, David K, DeVries, Keith M, Varie, David L
Format:	Artikel
Sprache:	eng
Online-Zugang:	Volltext
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