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.