Subscribe to Newsletter

An Update for Pharmaceutical Stress Testing Enabled by Modern Informatics Technologies

I. Introduction

A. Background on Stress Testing

Stress testing or forced degradation is well recognized as a fundamental part of the drug development process, specifically related to purity through control of stability. Control strategies for stability require “stability-indicating” analytical methods, The development and validation of such methods is built on the foundation of well-designed and conducted stress testing studies. The complete regulatory definition of stress testing is found in Q1A(R2).1 An excerpt of this definition is: “stress testing…can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.” Conditions for stressing include elevated heat and humidity, susceptibility to hydrolysis across a wide pH range, susceptibility to oxidative and photolytic degradation, and in the case of biologics, freeze-thaw cycles and shear (when appropriate).3 The primary goal is to induce pharmaceutically-relevant degradation pathways in a comprehensive manner, at levels that facilitate stability-indicating analytical method development and validation, such that all realistic degradation products (i.e., those formed during manufacturing, handling, and normal storage and distribution conditions) are formed and can be analytically detected. A more comprehensive list of the objectives of stress testing studies can be found elsewhere.4-7 The results of stress testing studies are to “…form an integral part of the information provided to regulatory authorities.”6 More recently, there are additional implications for the control of mutagenic degradation products, as outlined by ICH M7.8

Read the full article now

Log in or register to read this article in full and gain access to The Analytical Scientist’s entire content archive. It’s FREE!

Receive content, products, events as well as relevant industry updates from The Analytical Scientist and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

Related Application Notes
Expand the Typical Breath Analysis into a Dynamic real-time Analysis of Metabolic Changes

| Contributed by Plasmion GmbH

Ultra-sensitive nitrosamine detection via H2: speed up routine analysis up to 50%

| Contributed by Plasmion GmbH

Best practices for sample preparation for Mass Spectrometry

| Contributed by Bertin Technologies

Most Popular
Register to The Analytical Scientist

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Analytical Scientist magazine