IPEC Federation announces the availability of the updated IPEC Composition Guide for Pharmaceutical Excipients (Version 3, 2026). The guide was originally published in 2009.
This guide provides an approach for excipient manufacturers to establish excipient composition profiles. Composition profiles may be used for regulatory purposes, assessing quality consistency, manufacturing process monitoring and change control, establishing product specifications, or evaluating excipient safety by excipient suppliers and/or users.
Key enhancements in this version include:
- Inclusion for biotech and fermentation-derived excipients;
- Updates and reorganization of content for Section 4.1 Types of components and physico-chemical characterization of excipients;
- Addition of glossary terms and definitions for types of excipient components;
- Example of a composition profile template (Annex).
In addition, throughout the guide efforts were made to harmonise terminology, clarification, and remove redundancies.
The guide will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites.
For further information contact the IPEC Federation Secretariat at:
Download the Table of Contents of the Guide
About IPEC Federation
The IPEC Federation is a global organization that promotes quality in pharmaceutical excipients. The IPEC Federation represents the five current regional International Pharmaceutical Excipient Councils (IPECs) – IPEC-Americas, IPEC Europe, IPEC Japan, IPEC China and IPEC India – and provides a unified voice to promote the best use of pharmaceutical excipients in medicines as a means of improving patient treatment and safety.
Further details are available on the IPEC Federation website http://www.ipec-federation.org.