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The Japanese Pharmacopoeia, Sixteenth Edition, JP 16, March 2011, English
第十六改正日本薬局方, and may be abbreviated as 日局十六, 日局16, JP XVI or JP 16.
Author: Society of Japanese Pharmacopoeia
The JP XVI is an English edition published by PMRJ (former Society of Japanese Pharmacopoeia), having completely the same content with the Japanese Pharmacopoeia XVI official edition issued by the Ministry of Health, Labour and Welfares, which was promulgated on March 24, 2011 and became effective on April 1, 2011.
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 the following articles: General Notices; General Rules for Crude Drugs; General Rules for Preparations; General Tests Processes and Apparatus; Official Monographs including the monographs for crude drugs (1,764 items); Infrared and Ultraviolet-visible Reference Spectra; General Information.
It comprises in order as follows:
- The Ministry of Health
- Labour and Welfare
- Ministerial Notification
- 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
Extent 2320 pages
Format Hardback Published 25 May 2012