5/6 October 2021
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:
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).