Ipec excipient stability programme guide

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(See The IPEC Excipient Stability Program Guide, 2010). ICH Q1A(R2) Stability Testing of New Drug Substances and Products. The scope of the ICH Q1A(R2) International Pharmaceutical Excipients Council (IPEC) is an international industry excipient user. 16 The IPEC Excipient Stability Program Guide, 201009/15/2015 - IPEC Federation Publishes Position Paper on Third Party Audit and Certification Programmes Third party auditing and certification of excipient The IPEC Co-processed Excipient Guide for Pharmaceutical Excipients. 2017. First publication date: 2017 The IPEC Excipient Stability Program Guide. This document provides guidance for establishing a stability study program for a pharmaceutical excipient. The IPEC Excipient Stability Program Guide. First publication date: 2010. Latest publication date: 2010. (Version 1). Since excipients are different from. APIs and drug products, this document provides an appropriate guidance for developing supporting studies for excipients.