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Stability Existing Corrected March 2007

www.ema.europa.eu

Drug Substances and Products (CPMP/ICH/2736/99 corr) and sets out the stability testing requirements for existing active substances and related finished products. For the purposes of this guideline, an existing active substance is one that has been authorised previously through a finished product within the European Community1.

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Stability Existing Corrected March 2007

www.ema.europa.eu

CPMP/QWP/122/02, rev 1 corr EMEA 2007 3/18 STABILITY TESTING OF EXISTING ACTIVE SUBSTANCES AND RELATED FINISHED PRODUCTS 1. INTRODUCTION 1.1 Objectives of the Guideline

  Testing, Active, Stability, Substance, Existing, Stability testing, Stability existing, Existing active substances

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Existing, Substances, EXISTING ACTIVE SUBSTANCES, Existing active, Stability Existing, STABILITY TESTING