Chapter 5.21 "Chemometric Methods Applied to Analytical Data" to be Published in Ph. Eur. 11.1

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13-15 May 2025
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
During its 172nd session on 22 and 23 March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of general chapter 5.21. Chemometric methods applied to analytical data to be published in Ph. Eur. Supplement 11.1 and be effective as of 01 April 2023. The chapter was revised to reflect the latest developments in the field.
The draft version was published for comment in Pharmeuropa 33.3 last year. According to the EDQM press release, the revision includes:
- "an update of section 1. General aspects with a review of parts on Pre-processing (1.2.2.6) and Assessment and validation of chemometric methods (1.3);
- two new sub-sections on Independent component analysis (2.2) and Decision trees and random forests (2.6);
- a general review of sub-sections on Similarity measures (2.3), Clustering (2.5), Multiple linear regression (2.8), Principal component regression(2.9), Support vector machines for supervised classification (2.11) and Artificial neural networks (2.12);
- a new section, 3. Related application fields, including sub-sections on Chemometrics in chemical imaging (3.1), and Data fusion (3.2);
- an update of the Glossary and the Abbreviations"
In total, the Ph. Eur. Commission adopted revised versions of 71 texts during its 172nd session. For more information, please see the press release “Outcome of the 172nd session of the European Pharmacopoeia Commission, March 2022”.
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