Pharmacopoeia

An official compendium of quality standards, test methods and monographs for medicines. In a Japanese document, an unqualified reference to the pharmacopoeia means the Japanese Pharmacopoeia (日本薬局方, JP), which MHLW establishes under Article 41(1) of the PMD Act. Full revisions have come every five years, with supplements in between, and an English version is available free of charge, in which the Japanese original prevails. The JP has General Tests, for example 4.01 Bacterial Endotoxins Test and 4.06 Sterility Test, and Official Monographs. Some chapters are harmonized with Ph. Eur. and USP through the Pharmacopoeial Discussion Group, but not all, so check the JP text itself for products sold in Japan.