USP-NF Stimuli Article on Chromatographic Screening for Extractables and Leachables

In the Pharmacopeial Forum, PF 49(4), a stimuli article entitled "Proposals for the Development, Composition, and Routine Use of System Suitability Standard Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables" was published. The deadline for submitting comments is 30 September 2023.

In the introduction part, the authors start the article by stating that the purpose of the document "is to discuss reference standard mixtures and to disclose, discuss, and justify the system suitability standard mixtures the USP is developing for the commonly employed hyphenated chromatographic methods used for organic extractables and leachables screening." The introduction continues with a brief explanation of what extractables and leachables are and why they are important. Analytical strategies of targeting extractables and leachables, in particular chromatographic methods for potential organic compunds screening, are adressed. In this context, it is pointed out that "chromatographic methods used for extractables or leachables screening must be suited for this intended purpose." Therefore, different attributes of efficient and effective system suitability test mixtures and the USP perspective on such mixtures are discribed in the article.

In the experimental part, reagents and standards, laboratory items and the preparation of the system suitability standard mixture are outlined.

In the following section on results and discussion, the standard mixture's chromatographic performance is evaluated. Example chromatograms, that were generated by the following methods, are presented:

  • HS-GC/MS
  • GC/MS

In the conclusion, the authors write that "a practical rationale for using standardized reference standard mixtures to support system suitability assessment of chromatographic screening methods used for extractables and leachables has been proposed." USP is looking for feedback from relevant stakeholders. Based on that feedback, "USP will make necessary and appropriate adjustments to the proposed reference standard mixtures."

Finally, the next steps are summarized. Thus include:

  • Collection of feedback from stakeholders
  • Revision of standard mixtures
  • Qualifying batches of materials as reference standards
  • Stability assessment
  • Development of other standard mixtures

The full article is available on PF Online via the USP Website Access Point.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.