Kams,
For Europe it is possible to claim compliance with USP and use
alternative analytical methods provided that you have adequate data
to validate the methods as at least equivalent to those in the
monograph. You would also need to be able to demonstrate that your
material would comply with the USP specification if it was tested by
the official methods of analysis.
If a product is approved when there is no USP specification and
subsequently USP specifications are published it would be usual to
amend the authorisation to refer to USP specifications. Again, in
Europe if the monograph title is used as the name of a product
compliance with any monograph would be expected (although of course
priority would be given to compliance with Ph Eur specifications). I
leave to other to confirm whether the same expectation applies in the
US. However, I would advise you also to read the General Notices in
USP.
Regards,
Brian Matthews
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