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Pharmacopoeia

Japanese Pharmacopoeia

Published by MHLW / PMDA, Japan

The official pharmacopoeia of Japan and a member of the Pharmacopoeial Discussion Group.

Why it matters to you: Relevant for products exported to Japan; key micro chapters are harmonised with USP and Ph. Eur.

Pharmacopoeia volumes USP, Ph. Eur., IP and JP on a shelf with a magnifier over a chapterUSPPh. Eur.IPJP<61>TAMC

Key references for microbiology

ReferenceTopicIn short
4.05Microbiological examination of non-sterile productsEnumeration and specified organisms
4.06Sterility testHarmonised
4.01Bacterial endotoxins testHarmonised

Practical tips

  • Japanese general information chapters contain useful guidance on EM and water.

Other standards

Summarised in our own words for learning. Always refer to the current official text for exact requirements. How we use references