Changes planned for Pharmaceutical Water in the Chinese Pharmacopoeia

The Chinese Pharmacopoeia Committee (CPC) intends to revise monograph 0261 Pharmaceutical Water, as well as the conductivity measurement (0681). In order to ensure the scientific validity and applicability of the changes, the proposed revised text is now being published to solicit professional feedback. The comment period will run until 24 July 2024, and although these are still proposals, it can be assumed that they will be adopted in their current form, presumably by the end of the year.

The planned changes include

  • The authorisation of alternative methods for the production of WFI - that's the big news. However, purified water must still be used as feed water for the production of WFI. This is also the current requirement 
  • Abolition of chemical tests, as these are covered by the conductivity measurement 
  • Updating the conductivity method, which now corresponds to the USP method. The limit values for WFI correspond to both the USP and the European Pharmacopoeia. The limits for Purified Water are analogue to the higher EP limits compared to the USP 
  • A conductivity method for sterilised WFI has also been added, with limits analogous to USP & EP 
  • Greater emphasis on online testing methods

The planned changes are to be welcomed, as they represent further harmonisation between the various global pharmacopoeias.

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