Press Release
Brussels (Belgium), 16 November 2022

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces
the availability of the updated IPEC Stability Guide for Pharmaceutical Excipients (Version 2,2022). The guide was originally published in 2010. This guide is widely used globally.
The primary goal of the guide is to offer best practice and guidance when establishing excipientstability programs. The guide provides excipient manufacturers with strategies for assessing an
overall approach to stability and how to set up programs to support regulatory filings, aid inmaintaining the quality of the excipient, and to define and substantiate recommended storage
conditions and shelf-life claims. These include re-evaluation dates, expiration dates, and use-byby dates.
Following this guide provides confidence to the pharmaceutical end user that an excipient willcontinue to meet the excipient manufacturer’s specifications or monograph requirements if theexcipient is stored in an unopened container at its recommended storage condition up to the shelflife claim.
The most significant change to the guide is the re-arrangement of information found under section
2.1, “General Guidelines” for the excipient stability program. The 2010 version had separate
sections for defining and discussing specific requirements for very stable, stable and limited stable
excipients, along with a section on classification. However, the revised guide defines the uniquerequirements for very stable, stable and limited stable excipients within the classification section
and created separate sections, as shown below:
2010• Very stable (2.1.1)• Stable (2.1.2)• Limited stability (2.1.3)• Classification (2.1.4)

2022 revision• Classification (2.1.1) (including very stable,stable and limited stable)• Considerations for New or Chemically Novel
Excipients (2.1.2)• Considerations for Modifications to Excipients(2.1.3)• Ongoing Stability Studies (2.1.4)• Documentation (2.1.5)

Throughout the guide efforts were made to harmonize terminology, add clarification, reorganize
information and remove redundancies. Although limited changes were made to the structure andThe International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
Rue Marie de Bourgogne 52 - 1000, Brussels, Belgium
W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
VAT: BE 08239313 61 - IBAN: BE73 3630 6812 5160 - RPM Brussels Capital Regioncontent for sections 2.2 through 2.4, separate sections were created for out of specification results(2.3.8) and labelling (2.5).
Finally, the guide was converted to an IPEC Federation guide and the reference section wasupdated to include more current regulations and guides/guidelines.
The guide will be available, initially exclusively to IPEC members for a three-month period, on theIPEC Federation and national/regional members’ websites. Thereafter, the guide will be madeavailable to the general public.
For further information contact the IPEC Federation Secretariat at:+32 2 213 74 40 / info@ipec-federation.org

IPEC Federation asbl
The Federation of the International Pharmaceutical Excipients Council
Rue Marie de Bourgogne 52 – 1000 Brussels
T: +32 2 213 74 40

The International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
Rue Marie de Bourgogne 52 - 1000, Brussels, Belgium
W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
VAT: BE 08239313 61 - IBAN: BE73 3630 6812 5160 - RPM Brussels Capital Region