The Ministry of Health, Labour and Welfare Ministerial Notiˆcation No. 461 In accordance with the provisions of Article 41, Paragraph 1 of the Pharmaceutical AŠairs Law (Law No. 145, 1960), we hereby revise a part of the Japanese Phar- macopoeia (Ministerial Notiˆcation No. 111, 2001) as follows, and the revised Japanese Pharmacopoeia shall come into eŠect on January 1, 2005, [including dele- tion from O‹cial Monographs fro Part II in The Japanese Pharmacopoeia, Four- teenth Edition of the articles of Absorbent Cotton, Puriˆed Absorbent Cotton, Sterile Absorbent Cotton, Sterile Puriˆed Absorbent Cotton and Absorbent Gauze and Sterile Absorbent Gauze (hereinafter referred to as ``sanitary materials'')]. Provi- so: With respect to the drugs which are included in the Japanese Pharmacopoeia (hereinafter referred to as ``the old Japanese Pharmacopoeia'') [limited to those included in the Japanese Pharmacopoeia whose standards are changed with this notiˆcation published (hereinafter referred to as ``the new Japanese Phar- macopoeia'')] and those which are approved as of January 1, 2005 pursuant to the provisions of Article 14, Paragraph 1 of this Law (including cases where it shall apply mutatis mutandis under Article 23 of this Law; the same hereinafter) [including the drugs designated as those exempted from approval (hereinafter referred to as ``the drugs exempted from approval'') among the drugs etc. designated by the Minister of Health, Labour and Welfare as those exempted from manufacturing or import approval pursuant to the provisions of Article 14, Paragraph 1 of the Pharmaceutical AŠairs Law (Ministerial Notiˆcation No. 104, 1994), the standards established in the old Japanese Pharmacopoeia (limited to the standards for the relevant drugs) shall be recognized, up to June 30, 2006, as the standards established in the new Japanese Pharmacopoeia. With respect the drugs which are included in the new Japanese Pharmacopoeia (excluding those which are included in the old Japanese Phar- macopoeia) and those which are approved as of January 1, 2005 pursuant to the provisions of Article 14, Paragraph 1 of this Law (including the drugs exempted from approval), the drugs may be treated, up to June 30, 2006, as those which are not included in the new Japanese Pharmacopoeia. Further, sanitary materials may be treated, up to September 30, 2006, under the previous regulation. Hidehisa Otsuji The Minister of Health, Labour and Welfare December 28, 2004 (The texts 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, Phar- maceutical and Medical Safety Bureau, Ministry of Health, Labour and Welfare, at each Regional Bureau of Health and Welfare and at each Prefectural O‹ce in Japan.) The term ``as follows'' here indicates the contents from Part I to Ultraviolet-visible Reference SpectraintheSupplementIItotheJapanesePharmacopoeiaFourteenthEdition(pp.1669 – 1866). CONTENTS Preface ...................................................... i Supplement II to The Japanese Pharmacopoeia, Supplement II to The Japanese Pharmacopoeia, Fourteenth Edition, Part II................ 1755–1778 Fourteenth Edition, Part I................. 1669–1754 General Rules for Crude Drugs ............... 1755 General Tests, Processes and Apparatus ... 1669 O‹cial Monographs ............................. 1757 6. Bacterial Endotoxins Test................. 1669 39. Nuclear Magnetic Resonance Infrared Reference Spectra ................ 1779–1789 Spectroscopy ................................. 1669 Part I ................................................ 1779 47. Pyrogen Test ................................. 1672 Part II ............................................... 1789 52. Residue on Ignition Test .................. 1672 53. Speciˆc Surface Area Determination... 1673 Ultraviolet-visible Reference Spectra .... 1791–1799 54. Sterility Test .................................. 1673 Part I ................................................ 1791 70. Reference Standards; Reagents, Test Solu- tions; Standard Solutions for Volumetric General Information Analysis; Standard Solutions; Matching 5. International Harmonization Implemented Fluids for Color; Optical Filters for in the Japanese Pharmacopoeia Fourteenth Wavelength and Transmission Rate Edition ......................................... 1801 Calibration; and Measuring Instruments, 20. Amino Acid Analysis ...................... 1814 Appliances .................................... 1677 21. Capillary Electrophoresis.................. 1822 (1) Reference Standards ................. 1677 22. Isoelectric Focusing......................... 1828 (2) Reagents, Test Solutions............ 1677 23. Peptide Mapping ............................ 1830 (3) Standard Solutions for Volumetric 24. Rapid Identiˆcation of Microorganisms Analysis ................................. 1685 Based on Molecular Biological 74. Powder Particle Density Method ........................................ 1833 Determination................................ 1685 25. Solid and Particle Densities .............. 1835 O‹cial Monographs ............................. 1687 26. Total Protein Assay ........................ 1836 Index.................................................... 1841 Index in Japanese.................................... 1857 Preface The Fourteenth Edition of the Japanese Phar- and to securing and maintaining international con- macopoeia was promulgated on March 30, 2001 by sistency. Ministerial Notiˆcation No. 111 of the Ministry of It was also agreed that JP articles should cover Health, Labour and Welfare. To keep pace with drugs which are important from the viewpoint of progress in medical and pharmaceutical sciences, in health care and medical treatment, clinical results and November 2001, the Council, at a meeting of the frequency of use, as soon as possible after they reach Committee on Japanese Pharmacopoeia (JP), estab- the market. lished the basic principles for the preparation of the It was also decided to make a deˆnite rule for selec- JP Fifteenth Edition, setting out the characteristics tion of articles by clarifying the standards for selec- and roles of the JP, the deˆnite measures for the tion. The rule was shown in the verdict ``What the revision, the date of the revision, and the organization future Japanese Pharmacopoeia should be'' by the of the Subcommittee on JP. Pharmaceutical AŠairs and Food Sanitation Council At the above meeting, the following ``ˆve pillars'' (PAFSC) on December 2002. The JP Fifteenth were established as the basic principles of the JP: Edition was decided to be slated for completion in Making it more substantial by including all drugs April 2006. which are important from the viewpoint of health care The panels on JP was reorganized into the following and medical treatment; Making prompt partial eleven panels in accordance with the recommendation revision as necessary and facilitating smooth adminis- of the PAFSC: Panel on Planning and Revisions; trative operation; Promoting international harmoni- Panel on Nomenclature for Pharmaceuticals; Panel zation; Ensuring transparency regarding the revision on Excipients; Panel on Physico-chemical Tests; Panel and dissemination to the public of the JP; and on Medicinal Chemicals; Panel on Biologically Positively introducing contemporary analytical tests Derived Drugs; Panel on Biological Tests; Panel on and developing reference standards. It was decided at Antibiotics; Panel on Crude Drugs; Provisional Panel the meeting that each panel set up under the Subcom- on Planning and Revisions and Panel on Phar- mittee on JP should make eŠorts, on the basis of these macopoeial Harmonization (PDG), followed by the principles, to ensure that the JP is used more eŠective- establishment of new panels: Panel on Water for ly in the ˆelds of health care and medical treatment by Pharmaceutical Preparations, Panel on JP Reference taking appropriate measures, including getting the Standards, and three working groups under Panel on understanding and cooperation of other parties con- Medicinal Chemicals to expedite discussion of revision cerned. drafts of drug monographs. The JP should comprise an o‹cial standard being In the Committee on Japanese Pharmacopoeia, required to assure the quality of drugs in this country Mitsuru Uchiyama took the role of chairman from in response to the progress in science and technology January 2001 to December 2002, Tadao Terao from and clinical demands at the time, it should deˆne the January to June 2003, and Takao Hayakawa from standards for speciˆcations as well as the methods of July 2003 to December 2004. tests to assure the overall quality of all drugs in It was decided that the JP will be revised not only principle, and it should have a role in clarifying the every ˆve years, in line with the basic principles for the criteria for quality of drugs which are recognized to be preparation of the JP Fifteenth Edition, but also as important from the viewpoint of medical treatment. necessary to take account of recent progress of science At the same time, it was agreed that the JP should and in the interests of international harmonization. be prepared with the aid of the knowledge and In accordance with the revision principles, the experience of many persons involved in the phar- panels continued discussions on selection of articles, maceuticals, that it should have the characteristics of and revisions for General Notices, General Rules for an o‹cial standard, which