Pharmeuropa: Four Draft Chapters on Elemental Analysis Published for Comment
Recommendation
3/4 February 2026
Evaluation, Implementation and Use of Suitable Technologies
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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
15.12.2025FDA Warning Letter Criticises Handling of OOS Results at a Contract Laboratory
15.12.2025FDA Warning: No Recall Conducted Despite Confirmed Benzene Impurity
10.12.2025FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations
26.11.2025FDA Warning Letter Highlights Deficiencies in SST and HPLC Practices
13.11.2025Proposed Revision of USP <1225> Published in the Pharmacopeial Forum