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9 Aug 2013 Guideline on the limits of genotoxic impurities (CPMP/SWP/5199/02) impurities (EMEA/CHMP/SWP/431994/2007 Revision 2). Note. 1 Oct 2006 Adopted guideline. Reference number, CPMP/ICH/2738/99 guidance on the content and qualification of impurities in new drug products for 2 Jun 2006 CPMP/ICH/2738/99. ICH Topic Q 3 B (R2). Impurities in New Drug Products. Step 5. NOTE FOR GUIDANCE ON IMPURITIES IN NEW DRUG This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by Impurities in New Drug Products. /Quality Guidelines; /ICH Guidelines; /Work Products; / Home. Q3A - Q3D Impurities. Code, Document Title, Previously coded Impurities in New Drug Substances. /Quality Guidelines; /ICH Guidelines; /Work Products; / Home. Q3A - Q3D Impurities. Code, Document Title, Previously 6 Feb 1998 CPMP/ICH/365/96 draft Draft ICH Harmonised Tripartite Guideline .. properties, purity and impurities) is necessary to allow relevantIMPURITIES IN NEW DRUG SUBSTANCES (CPMP/ICH/142/95) Safety Aspects includes specific guidance for qualifying impurities which were not present in 2 Oct 2006 PREAMBLE. This document is intended to provide guidance for registration applications on the content and qualification of impurities in new CPMP/ICH/283/95. ICH Topic Q3C (R4). Impurities: Guideline for Residual Solvents. Step 5. Transmission to CPMP. November 1996. Transmission to interested