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Guideline on the Specification Limits for Residues …
www.ema.europa.euPage 3/34 EXECUTIVE SUMMARY The objective of this guideline is to recommend maximum acceptable concentration limits for the residues of metal catalysts or metal reagents that may be present in pharmaceutical substances or in
Note for guidance on specification limits for …
www.ema.europa.euCPMP/SWP/4446/00 EMEA 2002 1/ 23 NOTE FOR GUIDANCE ON SPECIFICATION LIMITS FOR RESIDUES OF METAL CATALYSTS 1. INTRODUCTION The objective of this guideline is to recommend, for the safety of the patient, maximum