Pharmacopoeia Grades Explained
USP, EP and BP describe the same material against three different monographs. Which one your formulation has to name, and why it matters at customs.
USP, EP and BP are not three qualities of material. They are three monographs — the United States, European and British pharmacopoeias — each describing tests and limits for what is often the same product from the same plant.
Which one you need is decided by where the finished formulation is registered, not by where the material is bought. A product filed against a European monograph has to be made with material tested against that monograph, and a certificate naming a different one does not substitute for it, however similar the limits look.
The monographs overlap heavily and diverge in specifics: the test methods, the reported limits and the impurities each one names are not identical. Material can meet one and fail another on a single line.
It matters at the border as well as in the plant. Where a grade is declared, the documents have to say the same thing the certificate of analysis says. Tell the technical desk which monograph your registration names and the material is offered against that one.
