WHO publishes Draft Working Document on Chromatography

Recommendation
13-15 May 2025
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
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
09.05.2025New ECA Guidance on Sampling and Sample Management
07.05.2025Public Consultation on ICH M13B Guideline on Bioequivalence launched in Switzerland
07.05.2025BioPhorum publishes Guidance for ICH Q2(R2) and Q14 Implementation
23.04.2025OTC Drug Production Ceased after FDA Warning Letter
23.04.2025EMA publishes Draft of ICH M13B Guideline on Bioequivalence
16.04.2025EMA publishes four new product-specific Bioequivalence Guidance