Understanding Impurities and Degradation in Drug Substances and Drug Products

Understanding Impurities and Degradation in Drug Substances and Drug Products

Impurity and degradation testing for pharmaceutical development and quality

Impurity and degradation testing is an important part of pharmaceutical development, control, and release. Understanding impurity sources, degradation pathways, and regulatory expectations can help inform appropriate specifications and analytical approaches for drug substances and drug products.

Smithers-Understanding-Impurities-and-Degradation-Whitepaper

In this whitepaper, Smithers experts Michael Creese, Helen Lewis, and Michelle Barnett discuss practical considerations and analytical challenges associated with impurity and degradation testing. The discussion explores impurity management across pharmaceutical development, stability, release testing, and commercial product investigations, with consideration of ICH Q3A(R2) and ICH Q3B(R2).

What is included in the whitepaper:

  • How to define an impurity profile and specification
  • Differences between in-process and degradation impurities
  • The relationship between API and drug product specifications
  • The importance of impurity identification
  • How release specifications relate to analytical method validation
  • Impurity and degradation considerations for excipients
  • How extractables and leachables knowledge supports impurity testing
  • ICH Q3A(R2) and ICH Q3B(R2) requirements
  • Regulatory expectations for leachables
  • How analytical expertise can support impurity investigations and commercial product issues

Download the whitepaper

Learn more about the practical considerations involved in pharmaceutical impurity and degradation testing. Download the whitepaper to explore insights from Smithers experts on impurity identification, degradation, analytical methods, E&L-related leachables, and regulatory expectations.

Smithers-Understanding-Impurities-and-Degradation-Whitepaper

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