| Japanese Pharmacopoeia Sixteenth Edition
£720.00
ISBN: 9784840812023
Author: Society of Japanese Pharmacopoeia
Publication Date: April 2012
Pagination: 2320 pages
Binding: A4
This is the revised Japanese Pharmacopoeia 16th Edition in English.
Japanese Pharmacopoeia 16th Edition main features and revisions:
- Full revision of General Rules for Preparations; including the classification of dosage forms by administration route and application site, etc., 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
- General Tests, Processes and Apparatus which were revised are
- 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
- Official Monographs provides 1764 articles, including 106 articles newly added, 15 articles delated and 330 articles revised
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| The Japanese Pharmacopoeia Fifteenth Edition
£645.50 RRP: £665 You save £19.50 (2.9%)
New Japanese Pharmacopoeia 16th Edition available
ISBN: 9784840809740
Author: Society of Japanese Pharmacopoeia
Publication Date: 27 Jun 2007
Pagination: 1,788 pages
Binding: A4 Hardback
This is the English version of the fifteenth edition of the Japanese Pharmacopoeia. It provides the official Japanese standard for the description and quality of drug substances and products.
It contains over 1,400 articles regarding:
- General rules for crude drugs
- General rules for preparations
- General tests
- Processes and apparatus
- Infrared reference spectra
- Ultraviolet-visual reference spectra
(published every 5 years)
Official from 31 March 2006.
This publication supersedes 'The Japanese Pharmacopoeia - 14th Edition - Supplement II' (ISBN 4840808686, 9784840808682.)
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| Japan's and ICH Guidelines for New Drug Registration 1999
£232.80 RRP: £240 You save £7.20 (3.0%)ISBN:9784840805698
Special Order - 5-7 working days
Provides Japan's latest regulations required for new drug approval applications and the related MHW notification, PAL, ordinance, etc ., including 17 Japan's guidelines with enforcement of GLP ordinance, handling of nonclinical safety data, procedure to conduct GLP on-site review, GLP compliance review guideline, toxicity studies of drugs, general pharmacology studies, nonclinicval pharmacokinetic studies, etc.; 36 ICH guidelines many of which have been implemented (Step 5) in Japan by being adopted with MHW notification published |
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