The Ministry of Health, Labour and Welfare Ministerial Notification No. 316 Pursuant to Paragraph 1, Article 41 of the Pharmaceutical AŠairs Law (Law No. 145, 1960), we hereby revise a part of the Japanese Pharmacopoeia (Ministerial Notiˆcation No. 285, 2006) as follows*, and the revised Japanese Pharmacopoeia shall come into eŠect on October 1, 2007. However, in the case of drugs which are listed in the Japanese Pharmacopoeia (hereinafter referred to as ``previous Phar- macopoeia'') [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notiˆcation (hereinafter referred to as ``new Pharmacopoeia'')] and drugs which have been approved as of October 1, 2007 as prescribed under Paragraph 1, Article 14 of the same law [including drugs the Minister of Health, Labour and Welfare speciˆes (the Ministry of Health and Welfare Ministerial Notiˆcation No. 104, 1994) as those exempted from marketing approval pursuant to Paragraph 1, Article 14 of the Pharmaceutical AŠairs Law (hereinafter referred to as ``drugs exempted from approval'')], the Name and Standards estab- lished in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards estab- lished in the new Pharmacopoeia before and on March 31, 2009. In the case of drugs which are listed in the new Pharmacopoeia (excluding those listed in the previous Pharmacopoeia) and drugs which have been approved as of October 1, 2007 as prescribed under Paragraph 1, Article 14 of the same law (including those exempted from approval), they may be accepted as those being not listed in the new Phar- macopoeia before and on March 31, 2009. Further, Standards listed in the section 9.01 Reference Standards of the General Tests, Processes and Apparatus of the previ- ous Pharmacopoeia at the end of application of this notiˆcation may be treated under the previous regulation irrespective of the prescription of the section 9.01(1) Refer- ence Standards of the General Tests, Processes and Apparatus of the new Phar- macopoeia. Yoichi Masuzoe The Minister of Health, Labour and Welfare September 28, 2007 (The text referred to by the term ``as follows'' are omitted here. All of them are made available for public exhibition at the Evaluation and Licensing Division, Pharmaceu- tical and Food Safety Bureau, Ministry of Health, Labour and Welfare, at each Regional Bureau of Health and Welfare, and at each Prefectural Office in Japan). *The term ``as follows'' here indicates the contents of Supplement I to the Japanese Pharmacopoeia Fifteenth Edition from General Notice to Ultraviolet-visible Reference Spectra (pp. 1789 – 1997). CONTENTS Preface ...................................................... i 9.22 Standard Solutions ........................ 1817 Supplement I to The Japanese Pharmacopoeia, 9.41 Reagents, Test Solutions................. 1817 Fifteenth Edition ............................. 1789–1997 9.42 Solid Supports/Column Packings for General Notices ................................... 1789 Chromatography........................... 1824 General Rules for Crude Drugs ............... 1791 O‹cial Monographs ................................ 1825 General Rules for Preparations ............... 1793 Crude Drugs ....................................... 1937 General Tests, Processes and Apparatus ... 1795 1.09 Qualitative Tests ........................... 1795 Infrared Reference Spectra ................ 1971–1986 2.01 Liquid Chromatography ................. 1795 2.02 Gas Chromatography..................... 1799 Ultraviolet-visible Reference Spectra .... 1987–1997 2.48 Water Determination (Karl Fischer Method) ...................................... 1801 General Information 2.49 Optical Rotation Determination ....... 1801 8. International Harmonization Implemented 4.01 Bacterial Endotoxins Test ............... 1802 in the Japanese Pharmacopoeia Fifteenth 4.05 Microbiological Examination of Non- Edition ......................................... 1999 sterile Products............................. 1802 12. Microbial Attributes of Non-sterile 6.01 Test for Metal Particles in Opthalmic Pharmaceutical Products.................. 2004 Ointments.................................... 1813 21. Quality Control of Water for 6.08 Insoluble Particulate Matter Test for Pharmaceutical Use......................... 2006 Ophthalmic Solutions..................... 1813 31. Purity Tests on Crude Drugs Using 6.10 Dissolution Test............................ 1813 Genetic Information........................ 2007 6.11 Foreign Insoluble Matter Test for Ophthalmic Solutions..................... 1814 Index.................................................... 2011 9.01 Reference Standards ...................... 1814 Index in Latin Name................................ 2027 9.21 Standard Solutions for Volumetric Index in Japanese.................................... 2029 Analysis ...................................... 1817 PREFACE The 15th Edition of the Japanese Pharmacopoeia drugs, which are important from the viewpoint of (JP) was promulgated by Ministerial Notification No. health care and medical treatment, clinical results and 285 of the Ministry of Health, Labour and Welfare frequency of use, as soon as possible after they reach (MHLW) on March 31, 2006. the market. In July 2006, the Committee on JP established the The target date for the publication of JP 16th Edi- basic principles for the preparation of the JP 16th Edi- tion (the Japanese edition) was set as April 2011. tion, setting out the roles and characteristics of the JP, JP Expert Committees are organized with the fol- the definite measures for the revision, and the date of lowing panels: Panel on the Principles of Revisions; the revision. Sub-committee on the Principles of Revisions; Panel At the above Committee, the five basic principles of on Medicinal Chemicals; Panel on Antibiotics; Panel JP, which we refer to as the ``five pillars'' were estab- on Biologicals; Panel on Crude Drugs; Panel on Phar- lished as follows: 1) Including all drugs which are im- maceutical Excipients; Panel on Physico-Chemical portant from the viewpoint of health care and medical Methods; Panel on Preparations; Panel on Physical treatment; 2) Making qualitative improvement by in- Methods; Panel on Biological Tests; Panel on Nomen- troducing the latest science and technology; 3) clature; Panel on International Harmonization; Panel Promoting internationalization; 4) Making prompt on Pharmaceutical Water; and Panel on Reference partial revision as necessary and facilitating smooth Standards. Furthermore, three working groups under administrative operation; and 5) Ensuring transparen- the Panel on Medicinal Chemicals are established to cy regarding the revision, and disseminating the JP to expedite discussion of revision drafts of Monographs. the public. It was agreed that the Committee on JP In the Committee on JP, Takao Hayakawa took the should make efforts, on the basis of these principles, role of chairman from March 2006 to September 2007. to ensure that the JP is used more effectively in the In addition to the regular revision every five years in fields of health care and medical treatment by taking line with the basic principles for the preparation of the appropriate measurements, including getting the un- JP it was agreed that partial revision should be done as derstanding and cooperation of other parties con- necessary to take account of recent progress of science cerned. and in the interests of international harmonization. It was agreed that the JP should provide an official In accordance with the above principles, the panels standard, being required to assure the quality of medi- initiated deliberations on selection of articles, and on cines in Japan in response to the progress of science revisions for General Notices, General Rules for and technology and medical demands at the time. It Crude Drugs, General Rules for Preparations, Gener- should define the standards for specifications, as well al Tests, Monographs and so on. as the methods of testing to assure overall quality of Draft revisions covering subjects in General No- all drugs in principle, and it should have a role in tices, General Rules for Crude Drugs, General Rules clarifying the criteria for quality assurance of drugs for Preparations, General Tests and Monographs, for that are recognized to be essential for public health which discussions were finished between September and medical treatment. 2005 and March 2007, were prepared for a supplement The JP has been prepared with the aid of the to the JP 15. They were examined by the Committee knowledge and experience of many professionals in on JP in April 2007, followed by the Pharmaceutical the pharmaceutical field. Therefore, the JP should Affairs and Food Sanitation Council (PAFSC) in June have the characteristics of an official standard, which 2007, and then submitted to the Minister of MHLW. might be widely used by all parties concerned. It Numbers of discussions in the panels to prepare the should provide information and understanding about supplement drafts were as follows: Panel on Principles the quality of drugs to the public, and it should be of Revisions (7); Sub-committee on the Principles of conducive to smooth and effective regulatory control Revisions (6); Panel on Medicinal Chemicals (33, in- of the quality of drugs, as well as promoting and cluding the working groups); Panel on Antibiotics (9); maintaining international consistency