Transcription of IPEC Stability Subcommittee
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IPEC Stability Subcommittee
Copyright 2010 The International Pharmaceutical Excipients Council The ipec Excipient Stability Program Guide 2010 Copyright 2010 The International Pharmaceutical Excipients Council Page i This document represents voluntary guidance for the pharmaceutical excipient industry and the contents should not be interpreted as regulatory requirements. Alternative approaches to those described in this guide may be implemented. FOREWORD ipec is an international industry association formed in 1991 by manufacturers and end-users of excipients. It is an association comprising four regional pharmaceutical excipient industry associations covering the United States, Europe, China and Japan. ipec s objective is to contribute to the development and harmonization of international excipient standards, the introduction of useful new excipients to the marketplace and the development of best practice and guidance concerning excipients.
Page 8 of 14 In selecting the packaging for conducting the stability study, the same care and : :
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