Japanese–English glossary
Monograph
Also called official monograph
モノグラフmonogurafu
Also written 公定書モノグラフ
The pharmacopoeial entry for a single substance or preparation, giving its definition, tests and acceptance criteria. In the Japanese Pharmacopoeia these are the Official Monographs, which sit alongside the General Notices and General Tests. When a Japanese specification cites a JP monograph, the material has to meet that monograph, and meeting the Ph. Eur. or USP monograph for the same substance is not automatically the same thing. That is why certificates for excipients and raw materials sold into Japan often name the JP separately. Monographs change with each JP revision and supplement, so record which version a specification refers to.