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

Recommendation

10-12 October 2023
Barcelona, Spain

Validation of Analytical Test Procedures & Measurement Uncertainty
Qualification and Validation in an uncertain analytical world – a holistic approach

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