Reagents for Pharmaceutical Quality Testing and Pharmacopoeia test methods
Fujifilm Wako handles various products that are used in pharmaceutical testing, such as reagents compliant with the general tests of the Japanese Pharmacopoeia, test solutions for disintegration and elution tests, reagents meeting the specifications of three pharmacopeias (Japanese Pharmacopoeia, United States Pharmacopeia [USP], and European Pharmacopoeia [EP]), and reagents for crude drug tests. We also handle devices and special reagents for endotoxin measurement. Fujifilm Wako provides comprehensive support for pharmaceutical testing and inspection.
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About the Japanese Pharmacopoeia
It is a standard for drugs established by the Minister of Health, Labour and Welfare after hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council as stipulated in Article 41 of the Pharmaceutical and Medical Device Act.*
*Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices
The Japanese Pharmacopoeia consists of General Notices, General Rules for Crude Drugs, General Rules for Preparations, General Tests, Processes and Apparatus, and Official Monographs, with a focus on pharmaceuticals commonly used in Japan.
General Notices:
Common rules for the entire Japanese Pharmacopoeia are defined.
- Units used in the Japanese Pharmacopoeia.
- Test conditions (temperature, pH, water to be used, etc.)
- Term definitions (explanation of solubility terms, etc.)
Contents including the above are described.
General Rules for Crude Drugs:
Common rules for crude drugs are defined.
- Descriptions, storage methods, etc. for crude drugs are specified.
General Rules for Preparations:
Common rules for preparations are defined
- General notices for preparations other than crude drugs, general notices for packaging, definition of dosage forms, manufacturing methods, test methods, containers, and storage methods are described.
General Tests, Processes and Apparatus:
Test methods common to each monograph, test methods useful for evaluating the quality of pharmaceuticals, and related items are defined.
- General methods, including chemical test methods (titration test, etc.), physical test methods (liquid chromatography test, etc.), and elution tests, and the grades, preparation methods, etc. of reagents and test solutions to be used in the tests are described.
Official Monographs:
The specifications of individual active pharmaceutical ingredients and preparations are defined. The descriptions of drugs, active pharmaceutical ingredients, and raw materials listed in the Japanese Pharmacopoeia as well as test methods for evaluating them are described.
General Information:
Reference items and test methods necessary to ensure the quality of pharmaceuticals.
Appendix:
Atomic weight table
For research use or further manufacturing use only. Not for use in diagnostic procedures.
Product content may differ from the actual image due to minor specification changes etc.
If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.