IPEC: Stability Guide for Excipients has been Updated
The IPEC Stability Guide for Pharmaceutical Excipients has been updated and is now available as version 3 (2026), as announced on the IPEC (International Pharmaceutical Excipients Council) website.
Following this guide gives pharmaceutical end users confidence that an excipient will continue to meet manufacturer specifications or monograph requirements when stored in an unopened container under recommended conditions throughout its shelf life.
The guide, which was originally published in 2010, provides excipient manufacturers with best practices and frameworks for establishing robust excipient stability programmes. It provides a structured approach to stability assessment, supporting regulatory submissions, ensuring ongoing compliance with quality requirements, and substantiating recommended storage conditions and shelf-life claims (including re-evaluation dates, expiration dates, and use-by dates).
Key enhancements in this version include:
- Three risk-based stability study designs
- Expanded best practice guidance covering a wide variety of topics
- Differentiation between excipient and API requirements
The guide will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites.
Source:
IPEC: Updated: IPEC Excipient Stability Guide for Pharmaceutical Excipients
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
