WHO publishes Draft Working Document on Chromatography

Recommendation
Monday, 29 September 2025 14.00 - 17.00 h
The World Health Organization (WHO) has published a draft proposal for inclusion in The International Pharmacopoeia. The new chapter 1.14.1 Chromatography shall replace the chapters 1.14.1 Thin-layer chromatography, 1.14.4 High-performance liquid chromatography and 1.14.5 Gas Chromatography.
The first draft working document was prepared based on the internationally-harmonized text developed by the Pharmacopoeial Discussion Group (PDG).
The following aspects are covered:
- Introduction: The introduction contains a short section on the definition of chromatography.
- Definitions: The section contains definitions and calculations of common parameters, e.g.
- Distribution constant
- Dwell volume
- Peak-to-valley ratio
- Plate height
- Plate number
- Relative retardation
- Resolution
- Separation factor
- Signal-to-noise ratio
- Symmetry factor
- System repeatability - System suitability: In this section, generally applicable requirements for system suitability are given. Only liquid chromatography and gas chromatography are covered.
- Adjustment of chromatographic conditions: The extent to which the various parameters of a chromatographic test may be adjusted without fundamentally modifying the pharmacopoeial analytical procedures are listed.
- Quantitation: The quantitation approaches that may be used in general texts or monographs are described.
- Other considerations: The new chapter concludes with some general aspects on
- Detector response
- Interfering peaks
- Measurement of peaks
- Reporting threshold
The draft working document (QAS/21.905) is available as a PDF file on the WHO homepage. Comments can be submitted until 25 March 2022.
Related GMP News
27.08.2025FDA Warning Letter: Missing Identity Tests, Unverified CoAs, and Inadequate DEG/EG Controls
20.08.2025USP Responds to Comments on Chapter <202> HPTLC Identification of Fixed Oils
13.08.2025USP publishes Comments rereived on Chapter <317>
13.08.2025FDA Issues Warning Letter to Contract Testing Laboratory for Inadequate OOS Investigations
06.08.2025EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence
06.08.2025FDA Warning Letter: Company Voluntarily Ceases Drug Production