WHO has published the draft of the new chapter of the International Pharmacopoeia on chromatography, entitled 1.41.1 Chromatography. The text is intended to replace the current chapters 1.14.1 (Thin-layer chromatography), 1.14.4 (High-performance liquid chromatography) and 1.14.5 (Gas Chromatography).
The roadmap for the publication of the new chapter plans to present the draft at the 56th meeting of the Committee of Experts on the Specifications of Pharmaceutical Preparations, between April 25 and May 2, 2022.
The guideline text of the PDG on chromatography
The draft represents the decision by the WHO to include in the International Pharmacopoeia the text - harmonized at international level - prepared by the PDG (Pharmacopeial Discussion Group).
The PDG has four representatives: WHO, USP (United States Pharmacopoeia), Ph.Eur. (European) and JP (Japanese).
In November 2021 he published his own General Chapter, entitled Chromatography, after a long coordination work promoted by Ph.Eur. and started as early as 2009.
The text focuses on the core requirements for chromatographic tests (CT, HPLC and GC), and is designed to integrate with the approaches adopted by each Pharmacopoeia, promoting the development of specific monographs through a common philosophy.
The structure of the new chapter
The WHO General Chapter is divided into six main parts:
Introduction: contains a brief description of the chromatographic separation techniques;
Definitions: lists in detail the parameters used to establish the acceptability criteria;
System suitability: specific for liquid and gas chromatography, this part describes the requirements for chromatographic systems and the tests necessary for their validation;
Adaptation of chromatographic conditions: specifies the limits and conditions within which it is possible to adapt a chromatographic test without modifying the analytical procedures of the pharmacopoeia;
Quantification: describes the quantitative approaches that can be used in the development of the chapters / monographs of each pharmacopoeia;
Other considerations: includes some considerations on certain issues: sensor response, interference peaks, peak measurement and the signaling threshold.
USP and JP announced the publication of their chromatography monographs by December 2022, while Ph.Eur. will publish its text in June 2022.
Source:
WHO - 1.14.1 CHROMATOGRAPHY Draft proposal for inclusion in The International Pharmacopoeia
European Council press release - PDG signs-off on milestone harmonized general chapter on chromatography
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