The International Pharmaceutical Excipients Council

Excipient Stability
Guide
For Pharmaceutical Excipients

Version 22022

Copyright © 2022 The International Pharmaceutical Excipients Council

This document represents voluntary guidance for the excipient industry and the contents
should not be interpreted as regulatory requirements. Alternatives to the approaches in thisguide may be used to achieve an equivalent level of assurance for excipient quality.
This guide was created to help companies understand current expectations on this topic and is
not intended for use by third party certification bodies to conduct audits or to certify
compliance with the guide.
The content of this guide cannot be reproduced without the written authorisation of the IPEC
Federation Management Body.

FOREWORD
The International Pharmaceutical Excipients Council (IPEC) is an international industry
association formed by excipient manufacturers, distributors and users. At the time of writing there
are regional pharmaceutical excipient industry associations located in the Americas, Europe,Japan, China, and India. IPEC’s objective is to contribute to international excipient standards
development and harmonization, provide information useful for new excipient development andintroduction, and offer best practice and guidance concerning excipient development.
IPEC has three major stakeholder groups:
1. Excipient manufacturers and distributors, defined as suppliers in this document,
2. Medicinal (drug) product manufacturers, defined as users in this document, and3. Public health and regulatory authorities.

This guide is intended to be voluntary, to indicate best practice, and to be globally applicable.
However, it should be recognized that the rules and regulations applying to excipients will varyfrom region to region and country to country. In addition, the rules and regulations are continually
evolving. It is the responsibility of the reader to review the latest version of the applicableregulatory guidance; however, the version referenced in the guide will be based on the version
available at the time the guide was published.

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Copyright © 2022 The International Pharmaceutical Excipients Council.

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 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

In this guide, pharmaceutical excipient(s) will be referred as excipient(s). This guide may be
applied to veterinary medicines, as appropriate with reference to specific veterinary guidance andregulations.
Throughout the guide, justification implies that a decision is made based on a scientific, quality
and/or regulatory considerations.
This guide offers best practice and guidance in the establishment of an excipient stability program.
The excipient supplier may be a manufacturer or a distributor (or both). The guide highlights thefactors to consider when planning and executing a scientific study that will determine the stabilityof an excipient.
Note:

Refer to the “International Pharmaceutical Excipients Council Glossary: General
Glossary of Terms and Acronyms [1]” for definitions. The first use of a term found in theglossary will be in BOLD.

2 of 16Copyright © 2022 The International Pharmaceutical Excipients Council.

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 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

Table of Contents
ACKNOWLEDGEMENTS .......................................................................................................... 41INTRODUCTION ............................................................................................................. 5

1.1Purpose ......................................................................................................................... 5

1.2

Scope ............................................................................................................................ 5

1.3

Principles Adopted ....................................................................................................... 52

EXCIPIENT STABILITY PROGRAMS ............................................................................. 6

2.1

General Guidelines ....................................................................................................... 6

2.1.1

Classification of Excipients ...................................................................................... 6

2.1.2

Considerations for New or Chemically Novel Excipients ....................................... 7

2.1.3

Considerations for Modifications to Excipients ...................................................... 7

2.1.4

Ongoing Stability Studies ......................................................................................... 72.1.5

Documentation .......................................................................................................... 72.2

Stability Studies ........................................................................................................... 8

2.3

Stability Protocols ........................................................................................................ 9

2.3.1

Objective ...................................................................................................................102.3.2

Scope ........................................................................................................................102.3.3

Selection and justification of representative batches ............................................102.3.4

Selection of packaging for stability studies ...........................................................102.3.5

Storage Conditions...................................................................................................112.3.6

Sampling Plan ...........................................................................................................112.3.7

Stability Test Methods..............................................................................................122.3.8

Out of Specification Results ....................................................................................122.3.9

Acceptance Criteria ..................................................................................................122.3.10

Approval Process .....................................................................................................13

2.4

Stability Reports ..........................................................................................................13

2.5

Labelling ......................................................................................................................13

3REFERENCES ...............................................................................................................15

3 of 16Copyright © 2022 The International Pharmaceutical Excipients Council.

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 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

ACKNOWLEDGEMENTS
This guide was developed by representatives from International Pharmaceutical Excipients
Council (IPEC) member companies. IPEC is an industry association whose members consist ofexcipient manufacturers, distributors, and users.
IPEC greatly appreciates the many hours devoted by the core team of individuals and othercontributors listed below, to make this guide available to IPEC members and the broader excipientcommunity. Equally, IPEC extends thanks to the employers of those same contributors whoprovide the necessary time and resources, without which, this guide would not be possible.
The company representatives who worked on this guide are listed below:

Contributors from IPEC-Americas
Michael Weedon, MilliporeSigma - Chair
Elizabeth Febbo, Henkel
David Fillar, Perrigo
Joseph Herforth, Colorcon
Charlotte McIlvaine, Univar Solutions
Evan Tarrant, Dow
Katherine Ulman, KLU Consulting
Priscilla Zawislak, IFF

Contributors from IPEC Europe
Jessica Kovac, Evonik
Anne (Lisa) Mitter, SymrisePatrick Oberjat, KLK Kolb
Bev Stout, GSK

Contributor from IPEC China
Shine Gao, Ron Pharm

Contributors from IPEC India
Several members from IPEC India represented through their US colleagues.

4 of 16Copyright © 2022 The International Pharmaceutical Excipients Council.

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 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region