New USP proposal for updating identity checks in U.S. Pharmacopeia

In the Pharmacopeial Forum 41(2), an article entitled 'Stimuli to the Revision Process' on the modernisation of the general chapter on identity checks <191> has been published in USP/NF. The same issue of PF 41(2) also contains the proposal to revise this existing general chapter <191>.

The chapter <191> treats the identification of ions or counterions in active substances that exist as salt compounds. The plan is to replace the existing flame test from <191> since it is not particularly meaningful. In future, selecting the options for identity checks in chapter <191> will be more flexible. Users will be able to apply other methods as long as they have been properly validated.

The following instrumental methods are being considered: 

  • X-ray fluorescence (XRF) 
  • Atom spectrometry (AA) 
  • ICP-OES 
  • ICP-MS 
  • IR 
  • Raman 
  • Ion chromatography

Other methods can also be used. However, the prerequisite here is that the user must document the specificity of a method as part of the validation.

For detailed information on the USP proposal, please see the USP website of Pharmacopeial Forum (PF).

Source: USP

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