About Us
Reference Standards
PMRJ has been registered by the Minister of Health, Labour and Welfare or the Prime Minister as an organization that produces and distributes Japanese Pharmacopoeia (JP) reference standards, Ministerial Ordinance coal-tar color for TLC reference standards, and Japan’s Specifications and Standards for food additives reference standard.
Regarding the use of JP and other compendial reference standards, please also refer to “Instructions for Use”.
Our Products
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Japanese Pharmacopoeia Reference Standard
Specified in the Japanese Pharmacopoeia as follows; (1) The reference standards which are prepared by those who have been registered to prepare them by the Minister of Health, Labour and Welfare, according to the Ministerial ordinance established by the Minister separately in the chapter of 9.01 Reference Standards of the section of General tests, Processes and Apparatus.
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Official Non-pharmacopoeial Reference Standard
Official reference standards used for the tests of pharmaceuticals
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Ministerial Ordinance coal-tar color for TLC Reference Standard
Coal-tar color for thin‐layer chromatography Reference Standards specified in Ministerial Ordinance specifying the coal-tar colors that can be used for pharmaceuticals and others
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Japan’s Specifications and Standards for Food Additives (JSFA) Reference Standard
Specified in the Japan’s Specifications and Standards for Food Additives as follows; (1) For Reference Standards listed in this section, use products manufactured by persons who are registered with the Prime Minister as specified by the Minister in the chapter of 4. Reference Standards of the section of C. Reagent, Solutions, and Other Reference Materials.
Other Reference Standards
Other official reference standards are as follows.
IMWP Reference Standard on Favipiravir
The International Meeting of World Pharmacopoeias (IMWP) is an international official meeting for participation of all WHO Member States’ pharmacopoeias worldwide, be they national, regional or international organized by WHO to discuss information exchange, international cooperation, international harmonization, etc.. The IMWP monographs on Favipiravir and on Favipiravir tablets were developed by the Japanese Pharmacopoeia with support from other pharmacopoeias. In addition, the reference substance IMWP RS on Favipiravir was established to be used for quantification of favipiravir and confirmation of system suitability for the IMWP monographs on Favipiravir and on Favipiravir tablets. PMRJ is responsible for distributing IMWP RS on Favipiravir. For further information on the IMWP monographs on Favipiravir and on Favipiravir tablets. Please see IMWP Website