Q 3 B (R2) Impurities in New Drug Products

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GUIDELINE ON TEST PROCEDURES AND ACCEPTANCE …

©EMEA 2005 5/35 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW VETERINARY DRUG SUBSTANCES AND NEW MEDICINALPRODUCTS: CHEMICAL SUBSTANCES 1. INTRODUCTION 1.1 Objective of the Guideline This guideline is intended to assist to the extent possible, in the establishment of a single set