WHO publishes Draft Working Document on Chromatography

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.

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