The Japanese pharmacopoeia - Hardcover

Pharmaceutical And Medical Device Regulatory Science Society Of Japan

9784840812023: The Japanese pharmacopoeia

Hardcover

ISBN 10: 4840812020 ISBN 13: 9784840812023

Publisher: Yakuji Nippo-sha, 2012

The Japanese Pharmacopoeia - Sixteenth Edition in English is fully endorsed by the Society of the Japanese Pharmacopoeia. It provides the official Japanese standard for the description and quality of drug substances and products. It comprises in order as follows: -The Ministry of Health -Labour and Welfare -Ministerial Notification -Contents -Preface -General Notices -General Rules for Crude Drugs -General Rules for Preparations -General Tests -Processes and Apparatus -Official Monographs, including Monographs for Crude Drugs -Infrared Reference Spectra -Ultraviolet-visual Reference Spectra General Information -Atomic Weight Table (2010) and Standard Atomic Weights 2010 as Appendix -Cumulative Index (English, Latin and Japanese titles) The Official Monographs section of the Japanese Pharmacopoeia contains approximately 1764 articles, including 106 newly added, 15 updated and 330 revised articles. Main features and revisions of this book are: -Full revision of General Rules for Preparations, including the classification of dosage forms by administration route and application site -The addition of 43 monographs for preparations, and the change of the definitions -Revision of General Notices, Official Monographs and General Information on pharmaceutical water Revisions have been made to the following tests, processes and apparatus: -2.01 Liquid Chromatography -2.46 Residual Solvents Test -2.51 Conductivity Measurement -2.54 pH Determination -2.58 X-Ray Powder Diffraction Method -3.01 Determination of Bulk and Tapped Densities -4.01 Bacterial Endotoxins Test -4.05 Microbial Limit Test -4.06 Sterility Test -5.02 Microbial Limit Test for Crude Drugs -6.03 Particle Size Distribution Test for Preparations -6.07 Insoluble Particulate Matter Test for Injections -6.08 Insoluble Particulate Matter Test for Ophthalmic Solutions -7.02 Test Methods for Plastic Containers -8.01 Sterilization and Aseptic Manipulation

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