COA Guideline - IPEC-AMERICAS
This document offers best practice and guidance on the content of an excipient . Certificate of Analysis (COA). TABLE OF CONTENTS . FOREWORD i. ACKNOWLEDGEMENTS iii. 1 INTRODUCTION 1. 1.1 Purpose 1. 1.2 Scope 1. 1.3 Principles Adopted 1. 2 GENERAL GUIDANCE 1. 3 DESIGN AND REQUIRED ELEMENTS OF A COA 1. 4 COA CONTENT 3. 4.1 Identifying ... ................
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