Reagents in pharmacopoeal tests

[marina1111]

Good evening! In pharmacopoeal tests do I have to use regents prescribed by pharmacopoeia? Such as ACS for USP? Reagents R for EP? Can I use pure reagents such as HPLC grade or analytical grade instead? If I perform method verification (repeatability, accuracy) for pharmacopeal tests such as HPLC tests, do I still have to use reagents given by pharmacopoeia or reagents that I used during verification can be used? I am asking from compliance point of view, not analytical point of view. If this is not right discussion group, can you direct me to correct discussion group? Thank You

[Hollow]

I would look at the specification of the substance in pharmacopoeia and compare it with the one you want to use.
if all parameter are fulfilled it should be ok, if some points are missing you can test them by yourself or buy one that has the specified label.
If a supplier sell them as "reag xyz" grade only means that they've tested it according to the Pharmacopoeia tests.

[Alfred88]

Dear marina1111.
I my view (compliance), using the grades as required in the monographs is the best option, since you do not need to explain/justify.
You may choose the multi-grade reagents/materials, e.g. EP/USP/JP in certain cases.
Alfred