SUPPLEMENT I TO THE JAPANESE PHARMACOPOEIA …

1 SUPPLEMENT ITOTHE JAPANESEPHARMACOPOEIASEVENTEENTH EDITIONO cial from December 1, 2017 English VersionTHE MINISTRY OF HEALTH, LABOUR AND WELFAREN otice: ThisEnglish Versionof the JAPANESE PHARMACOPOEIA is publishedfor the convenience of users unfamiliar with the JAPANESE language. Whenand if any discrepancy arises betweenthe JAPANESE original and its Englishtranslation, the former is in JapanThe Ministry of Health, Labour andWelfare Ministerial Notification No. 348 Pursuant to Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy andSafety of Products including Pharmaceuticals and Medical Devices (Law No. 145,1960), we hereby revise a part of the JAPANESE PHARMACOPOEIA (Ministerial Notifica-tion No. 64, 2016) as follows*. However, in the case of drugs which are listed in thePharmacopoeia (hereinafter referred to as ``previous PHARMACOPOEIA '') [limited tothose listed in the JAPANESE PHARMACOPOEIA whose standards are changed in accor-dance with this notification (hereinafter referred to as ``new PHARMACOPOEIA '')] anddrugs which have been approved as of December 1, 2017 as prescribed under Para-graph 1, Article 14 of the same law [including drugs the Minister of Health, Labourand Welfare specifies (the Ministry of Health and Welfare Ministerial NotificationNo.)]

2 104, 1994) as of November 30, 2017 as those exempted from marketing approvalpursuant to Paragraph 1, Article 14 of the same law (hereinafter referred to as ``drugsexempted from approval'')], the Name and Standards established in the previousPharmacopoeia (limited to part of the Name and Standards for the drugs concerned)may be accepted to conform to the Name andStandards established in the new Phar-macopoeia before and on May 31, 2019. In the case of drugs which are listed in thenew PHARMACOPOEIA (excluding those listed in the previous PHARMACOPOEIA ) anddrugs which have been approved as of December 1, 2017 as prescribed under theParagraph 1, Article 14 of the same law (including those exempted from approval),they may be accepted as those being not listed in the new PHARMACOPOEIA before andon May 31, Minister of Health, Labour and WelfareDecember 1, 2017(The text referred to by the term ``as follows'' are omitted here.

3 All of them are madeavailable for public exhibition at the pharmaceutical Evaluation Division, Phar- maceutical Safety and Environmental Health Bureau, Ministry of Health, Labourand Welfare, at each Regional Bureau of Health and Welfare, and at each PrefecturalOffice in Japan).*The term ``as follows'' here indicates the content of SUPPLEMENT I to the JAPANESE PharmacopoeiaSeventeenth Edition from General Notice to Ultraviolet-visible Reference Spectra (pp. 2631 2811). iSupplement I to The JAPANESE PHARMACOPOEIA ,Seventeenth 2811 General Rules for Preparations .. 2631 General Tests, Processes and Apparatus .. Ultraviolet-visible Residual Solvents .. Laser Diffraction Measurement ofParticle Digestion Test .. Uniformity of Dosage Units .. Test for Acid-neutralizing Capacityof Gastrointestinal Uniformity of Delivered Dose forInhalations .. AerodynamicParticleSizeMeasure-ment for Reference Standards.

4 Standard Solutions for VolumetricAnalysis .. Reagents, Test Solid Supports/Column Packings 2670O cial 2671 Crude Drugs and Related 2747 Infrared Reference 2805 Ultraviolet-visible Reference 2811 General InformationG2 Solid-state PropertiesLaser Diffraction Measurement of Par-ticle 2813 Powder Fineness .. 2813 Powder 2813 Solid and Particle Densities .. 2814G3 Biotechnological/Biological ProductsAmino Acid 2814 Enzyme-linked Immunosorbent Assay(ELISA).. 2814G5 Crude DrugsPurity Tests on Crude Drugs usingGenetic Information .. 2818On the Scientific Names of Crude Drugslisted in the JP .. 2819G6 Drug FormulationAerodynamicParticleSizeMeasur e-ment for Inhalations by Glass 2820G7 Containers and PackageGlass Containers for PharmaceuticalProducts .. 2822 Moisture Permeability Test for BlisterPackaging of Solid Preparations .. 2824G10 OthersBasic Concepts for Quality Assuranceof Drug Substances and DrugProducts.

5 2826 Criteria for Content Uniformity in RealTime Release Testing by ProcessAnalytical 2826 International Harmonization Imple-mented in the JAPANESE Pharma-copoeia Seventeenth Edition .. 2829 Stability Testing of Drug Substancesand Drug 2841 Index in Latin 2861 Index in 2863iiPREFACEThe 17th Edition of the JAPANESE PHARMACOPOEIA (JP) was promulgated by Ministerial of the Ministry of Health, Labour and Welfare(MHLW) on March 7, July 2016, the Committee on JP established thebasic principles for the preparation of the JP 18th Edi-tion, setting out the roles and characteristics of the JP,the definite measures for the revision, and the date ofthe the Committee, the five basic principles of JP,which we refer to as the ``five pillars'', were estab-lished as follows: 1) Including all drugs which are im-portant from the viewpoint of health care and medicaltreatment; 2) Making qualitative improvement by in-troducing the latest scienceand technology; 3) Furtherpromoting internationalization in response to globali-zation of drug market.

6 4) Making prompt partialrevision as necessary and facilitating smooth adminis-trative operation; and 5) Ensuring transparency re-garding the revision, and disseminating the JP to thepublic. It was agreed that the Committee on JP shouldmake efforts, on the basis of these principles, toensure that the JP is used more effectively in the fieldsof health care and medical treatment by taking ap-propriate measurements, including getting the under-standing and cooperation of other parties was agreed that the JP should provide an officialstandard, being required to assure the quality of medi-cines in Japan in response to the progress of scienceand technology and medical demands at the time. Itshould define the standards for specifications, as wellas the methods of testing to assure overall quality ofall drugs in principle, and it should have a role inclarifying the criteria for quality assurance of drugsthat are recognized to be essential for public healthand medical JP has been prepared with the aid of theknowledge and experience of many professionals inthe pharmaceutical field.

7 Therefore, the JP shouldhave the characteristics of an official standard, whichmight be widely used by all parties concerned, and itshould play an appropriate role of providing informa-tion and understanding about the quality of drugs tothe public. Moreover, as a pharmaceutical qualitystandard, it should contribute promoting and main-taining of advancedness as well as international con-sistency and harmonization of technical requirementsin the international was also agreed that JP articles should coverdrugs, which are important from the viewpoint ofhealth care and medical treatment, clinical perfor-manceormeritsandfrequencyofuse,as soonaspos-sible after they reach the target date for the publication of JP 18th Edi-tion (the JAPANESE edition) was set as April drafts are discussed in the following committeesthat were established in the Pharmaceuticals andMedical Devices Agency: Expert Committee; Sub-expert Committee; Sub-committee on ManufacturingProcess-related Matters; Committee on Chemicals;Committee on Antibiotics; Committee on Biologicals;Committee on Crude Drugs; Committee on Pharma-ceutical Excipients.

8 Committee on Physico-ChemicalMethods; Committee on Drug Formulation; Commit-tee on Physical Methods; Committee on BiologicalMethods; Committee on Nomenclature for Pharma-ceuticals; Committee on International Harmoniza-tion; and Committee on Reference Standards. Fur-thermore, working groups are established under theCommittee on pharmaceutical Excipients, Committeeon Physico-Chemical Methods and Committee onDrug the Committee on JP, Mitsuru Hashida took therole of chairman fromJanuary 2011 to addition to the regular revision every five years inline with the basic principles for the preparation of theJP it was agreed that partial revision should be done asnecessary to take account of recent progress of scienceand in the interests of international accordance with the above principles, the com-mittees initiated deliberations on selection of articlesand on revisions for General Notices, General Rulesfor Crude Drugs, General Rules for Preparations,General Tests, Monographs and so revisions covering subjects in General No-tices, General Rules for Crude Drugs, General Rulesfor Preparations, General Tests and Monographs.

9 Forwhich discussions were finished between August 2015and March 2017, were prepared for a SUPPLEMENT tothe JP 17. They were examined by the Committee onJP in April 2017, followed by the pharmaceutical Af-fairs and Food Sanitation Council (PAFSC) in June2017, and then submitted to the Minister of Health,Labour and of discussions in the committees to pre-iiiiSupplement I, JP XVIIP refacepare the SUPPLEMENT drafts were as follows: ExpertCommittee (8); Sub-committee on ManufacturingProcess-related Matters (9), Committee on Chemicals(20), Committee on Antibiotics (5); Committee onBiologicals (8); Committee on Crude Drugs (17);Committee on pharmaceutical Excipients (10); Com-mittee on Physico-Chemical Methods (14, including aworking group); Committee on Drug Formulation(27, including working groups); Committee on Physi-cal Methods (8); Committee on Biological Methods(6); Committee on Nomenclature for Pharmaceuticals(7); Committee on International Harmonization (6).

10 And Committee on Reference Standards (4).It should be noted that in the preparation of thedrafts for the SUPPLEMENT , generous cooperation wasgiven by the pharmaceutical Technology Committeeof the Osaka pharmaceutical Manufacturers Associa-tion, the Pharmacopeia and CMC Committee of thePharmaceutical Manufacturer's Association ofTokyo, the Tokyo Crude Drugs Association, the In-ternational pharmaceutical Excipients Council Japan,the Home Medicine Association of Japan, the JapanKampo Medicines Manufacturers Association, theJapan Flavor and Fragrance Materials Association,the Japan Medical Plants Federation, the Japan Phar- maceutical Manufacturers Association, the Federationof pharmaceutical Manufacturers' Association ofJapan, the Parenteral DrugAssociation Japan Chap-ter, the Japan Reagent Association, the Japan Oil-seeds Processors Association, the Japan AnalyticalInstruments Manufacturers' Association.