Pharmeuropa: Four Draft Chapters on Elemental Analysis Published for Comment
Recommendation

Monday, 21 September 2026 14.00 - 16.00 h
Regulatory Landscape: ECHA, USP, Pharmacopoeias and FDA Enforcement
In the Pharmeuropa issue 37.2, four draft chapters on elemental analysis methods were published for public comment. This concerns AES, AAS, ICP-AES, and ICP-MS.
As usual, the texts are available in both English and French. The English titles are:
- 2.2.22. Atomic emission spectrometry
- 2.2.23. Atomic absorption spectrometry
- 2.2.57. Inductively coupled plasma-atomic emission spectrometry
- 2.2.58. Inductively coupled plasma-mass spectrometry
According to the briefing notes, the four texts have undergone a complete revision. Nonetheless,"the changes are primarily editorial, with the addition of certain definitions and explanations. The primary objective of the revision is the harmonisation of equipment performance, system suitability and method validation requirements" within the general chapters for elemental analysis.
The revised texts provide a uniform structure with the following subsections:
- Principle
- Equipment
- Equipment performance
- Procedure
- Validation requirements
The full texts, along with further details on the revision, are available on the Pharmeuropa website after registration. Comments may be submitted until 30 June 2025.
Related GMP News
03.09.2026USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc
02.09.2026USP Publishes Comments Received on Chapter <320>
26.08.2026New USP Requirements for Asbestos Testing in Pharmaceutical Talc
19.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests


