THE JAPANESE PHARMACOPOEIA
JP XVIITHE JAPANESE PHARMACOPOEIASEVENTEENTH EDITIONOfficial from April 1, 2016English VersionTHE MINISTRY OF HEALTH, LABOUR AND WELFARE
Notice: This English Version of the Japanese Pharmacopoeia is publishedfor the convenience of users unfamiliar with the Japanese language. Whenand if any discrepancy arises between the Japanese original and its Englishtranslation, the former is authentic.
The Ministry of Health, Labour andWelfare Ministerial Notification No. 64Pursuant to Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy andSafety of Products including Pharmaceuticals and Medical Devices (Law No. 145,1960), the Japanese Pharmacopoeia (Ministerial Notification No. 65, 2011), whichhas been established as follows*, shall be applied on April 1, 2016. However, in thecase of drugs which are listed in the Pharmacopoeia (hereinafter referred to as previous Pharmacopoeia'') [limited to those listed in the Japanese Pharmacopoeia whosestandards are changed in accordance with this notification (hereinafter referred to as new Pharmacopoeia'')] and have been approved as of April 1, 2016 as prescribedunder Paragraph 1, Article 14 of the same law [including drugs the Minister ofHealth, Labour and Welfare specifies (the Ministry of Health and Welfare MinisterialNotification No. 104, 1994) as of March 31, 2016 as those exempted from marketingapproval pursuant to Paragraph 1, Article 14 of the Same Law (hereinafter referredto as drugs exempted from approval'')], the Name and Standards established in theprevious Pharmacopoeia (limited to part of the Name and Standards for the drugsconcerned) may be accepted to conform to the Name and Standards established in thenew Pharmacopoeia before and on September 30, 2017. In the case of drugs whichare listed in the new Pharmacopoeia (excluding those listed in the previous Pharmacopoeia) and drugs which have been approved as of April 1, 2016 as prescribedunder Paragraph 1, Article 14 of the same law (including those exempted fromapproval), they may be accepted as those being not listed in the new Pharmacopoeiabefore and on September 30, 2017.Yasuhisa ShiozakiThe Minister of Health, Labour and WelfareMarch 7, 2016(The text referred to by the term as follows'' are omitted here. All of them are madeavailable for public exhibition at the Evaluation and Licensing Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, at each Regional Bureau of Health and Welfare, and at each Prefectural Officein Japan).*The term as follows'' here indicates the contents of the Japanese Pharmacopoeia Seventeenth Editionfrom General Notice to Ultraviolet-visible Reference Spectra (pp. 1 – 2405).
ContentsCONTENTSPreface.iThe Japanese Pharmacopoeia, Seventeenth Edition.1General Notices .1General Rules for Crude Drugs.5General Rules for Preparations.7General Tests, Processes and Apparatus.251. Chemical Methods1.01 Alcohol Number Determination .251.02 Ammonium Limit Test .271.03 Chloride Limit Test.281.04 Flame Coloration Test .281.05 Mineral Oil Test .281.06 Oxygen Flask Combustion Method.281.07 Heavy Metals Limit Test .291.08 Nitrogen Determination (SemimicroKjeldahl Method).301.09 Qualitative Tests.311.10 Iron Limit Test .361.11 Arsenic Limit Test .371.12 Methanol Test.381.13 Fats and Fatty Oils Test .381.14 Sulfate Limit Test .401.15 Readily Carbonizable Substances Test .412. Physical MethodsChromatography2.01 Liquid Chromatography.412.02 Gas Chromatography .442.03 Thin-layer Chromatography .462.04 Amino Acid Analysis of Proteins .46Spectroscopic Methods2.21 Nuclear Magnetic ResonanceSpectroscopy.472.22 Fluorometry .492.23 Atomic AbsorptionSpectrophotometry.492.24 Ultraviolet-visible Spectrophotometry.512.25 Infrared Spectrophotometry .52Other Physical Methods2.41 Loss on Drying Test .532.42 Congealing Point Determination .542.43 Loss on Ignition Test.542.44 Residue on Ignition Test .552.45 Refractive Index Determination .552.46 Residual Solvents.552.47 Osmolarity Determination .612.48 Water Determination (Karl FischerMethod).622.49 Optical Rotation Determination .652.50 Endpoint Detection Methods inTitrimetry .662.512.522.532.542.552.56Conductivity Measurement .68Thermal Analysis.69Viscosity Determination .71pH Determination.74Vitamin A Assay .75Determination of Specific Gravity andDensity .762.57 Boiling Point and Distilling RangeTest .782.58 X-Ray Powder Diffraction Method .792.59 Test for Total Organic Carbon .832.60 Melting Point Determination.842.61 Turbidity Measurement .852.62 Mass Spectrometry.862.63 Inductively Coupled Plasma-AtomicEmission Spectrometry and InductivelyCoupled Plasma-Mass Spectrometry .912.64 Glycosylation Analysis of Glycoprotein .952.65 Methods for Color Matching.963. Powder Property Determinations3.01 Determination of Bulk and TappedDensities .983.02 Specific Surface Area by GasAdsorption .1003.03 Powder Particle DensityDetermination .1033.04 Particle Size Determination .1043.05 Water-Solid Interactions: Determination ofSorption-Desorption Isotherms and ofWater Activity .1084. Biological Tests/Biochemical Tests/Microbial Tests4.01 Bacterial Endotoxins Test .1104.02 Microbial Assay for Antibiotics.1144.03 Digestion Test .1174.04 Pyrogen Test .1204.05 Microbiological Examination of Non-sterileProducts.1214.06 Sterility Test.1305. Tests for Crude Drugs5.01 Crude Drugs Test .1345.02 Microbial Limit Test for Crude Drugs andPreparations containing Crude Drugs asMain Ingredient .1386. Tests for Preparations6.01 Test for Metal Particles in OphthalmicOintments.1476.02 Uniformity of Dosage Units .1476.03 Particle Size Distribution Test forPreparations.1506.04 Test for Acid-neutralizing Capacity ofGastrointestinal Medicines.1506.05 Test for Extractable Volume ofParenteral Preparations .1506.06 Foreign Insoluble Matter Test forInjections .151
Contents6.07Insoluble Particulate Matter Test forInjections .1516.08 Insoluble Particulate Matter Test forOphthalmic Solutions.1546.09 Disintegration Test .1556.10 Dissolution Test .1576.11 Foreign Insoluble Matter Test forOphthalmic Liquids and Solutions .1616.12 Methods of Adhesion Testing .1616.13 Release Test for Preparations for CutaneousApplication .1637. Tests for Containers and Packing Materials7.01 Test for Glass Containers for Injections .1667.02 Test Methods for Plastic Containers.1677.03 Test for Rubber Closure for AqueousInfusions .1729. Reference Standards; Standard Solutions;Reagents, Test Solutions; MeasuringInstruments, Appliances, etc.Reference Standards9.01 Reference Standards .174Standard Solutions9.21 Standard Solutions for VolumetricAnalysis .1779.22 Standard Solutions .1899.23 Matching Fluids for Color .191Reagents, Test Solutions, etc.9.41 Reagents, Test Solutions .1919.42 Solid Supports/Column Packings forChromatography .3529.43 Filter Papers, Filters for filtration,Test Papers, Crucibles, etc. .3549.44 Standard Particles, etc.355Measuring Instruments and Appliances,Thermometers, etc.9.61 Optical Filters for Wavelength andTransmission Rate Calibration .3559.62 Measuring Instruments, Appliances.3559.63 Thermometers .356Official Monographs .359Crude Drugs and Related Drugs .1791Infrared Reference Spectra .2015–2222Ultraviolet-visible Reference Spectra .2225–2405General InformationG1 Physics and ChemistryNear Infrared Spectrometry.2409pH Test for Gastrointestinal Medicine .2412System Suitability.2412Test for Trace Amounts of Aluminum inTotal Parenteral Nutrition (TPN)Solutions .2414Validation of Analytical Procedures .2415G2 Solid-state PropertiesLaser Diffraction Measurement ofJP XVIIParticle Size .2418Measurement of the Diameter of ParticlesDispersed in Liquid by Dynamic LightScattering .2422Powder Fineness .2424Powder Flow.2425Solid and Particle Densities .2427G3 Biotechnological/Biological ProductsAmino Acid Analysis .2428Basic Requirements for Viral Safety ofBiotechnological/Biological Productslisted in Japanese Pharmacopoeia .2435Capillary Electrophoresis .2447Isoelectric Focusing .2452Mass Spectrometry of Peptides andProteins .2454Monosaccharide Analysis and OligosaccharideAnalysis/Oligosaccharide Profiling .2456Mycoplasma Testing for Cell Substrates usedfor the Production of Biotechnological/Biological Products.2460Peptide Mapping.2464Qualification of Animals as Origin ofAnimal-derived Medicinal Productsprovided in the General Notices ofJapanese Pharmacopoeia and OtherStandards .2467SDS-Polyacrylamide Gel Electrophoresis .2469Surface Plasmon Resonance .2474Total Protein Assay .2478G4 MicroorganismsDecision of Limit for BacterialEndotoxins .2481Disinfection and Decontamination Methods.2481Media Fill Test (Process Simulation) .2484Microbial Attributes of Non-sterilePharmaceutical Products .2486Microbiological Environmental MonitoringMethods of Processing Areas for SterilePharmaceutical Products .2489Parametric Release of Terminally SterilizedPharmaceutical Products .2494Preservatives-Effectiveness Tests.2499Rapid Counting of Microbes usingFluorescent Staining.2501Rapid Identification of MicroorganismsBased on Molecular Biological Method .2503Rapid Microbial Methods .2505Sterilization and Sterilization Indicators .2507G5 Crude DrugsAnalytical Methods for Aflatoxins in CrudeDrug and Crude Drug Preparations .2513Aristolochic Acid .2515Notification for the Quantitative MarkerConstituents of Crude Drugs and Crude
JP XVIIDrug Preparations .2515Purity Tests on Crude Drugs using GeneticInformation .2516Quantitative Analytical Technique UtilizingNuclear Magnetic Resonance (NMR)Spectroscopy and its Application to Reagentsin the Japanese Pharmacopoeia.2519On the Scientific Names of Crude Drugslisted in the JP .2520Thin-layer Chromatography for Crude Drugsand Crude Drug Preparations .2534G6 Drug FormulationStandard Procedure for Mechanical Calibrationof Dissolution Apparatus .2536Tablet Friability Test .2538G7 Containers and PackageBasic Requirements and Terms for the Packagingof Pharmaceutical Products.2538Basic Requirements for Plastic Containers forPharmaceutical Use and Rubber Closures forContainers for Aqueous Infusions .2542G8 WaterQuality Control of Water for PharmaceuticalUse .2543Water to be used in the Tests of Drugs .2550G9 Reference StandardsReference Standards and Reference MaterialsSpecified in the Japanese Pharmacopoeia.2550G10 OthersBasic Concepts for Quality Assurance of DrugSubstances and Drug Products .2553Basic Concept of Quality Risk Management.2554International Harmonization Implementedin the Japanese Pharmacopoeia SeventeenthEdition.2557AppendixAtomic Weight Table (2010) .2595Standard Atomic Weights 2010 .2596Index .2599Index in Latin name .2616Index in Japanese.2618Contents
PREFACEThe Japanese Pharmacopoeia (JP) is an officialdocument that defines the specifications, criteria andstandard test methods necessary to properly assure thequality of medicines in Japan.Paragraph 2, Article 41 of the Law on SecuringQuality, Efficacy and Safety of Products includingPharmaceuticals and Medical Devices stipulates thatfull-fledged JP revisions shall be presented at leastevery 10 years. Since the JP 9th edition, full-fledgedrevisions have been made every 5 years. In addition tothe full-fledged revisions, a supplement has beenpromulgated twice in every 5 years since the JP 12thedition as well as partial revisions have been made asnecessary to take account of recent progress of scienceand in the interests of international harmonization.The 16th Edition of the JP was promulgated byMinisterial Notification No. 65 of the Ministry ofHealth, Labour and Welfare (MHLW) on March 24,2011.In July 2011, the Committee on JP established thebasic principles for the preparation of the JP 17th Edition, setting out the roles and characteristics of the JP,the definite measures for the revision, and the date ofthe revision.At the Committee, the five basic principles of JP,which we refer to as the five pillars'', were established as follows: 1) Including all drugs which are important from the viewpoint of health care and medicaltreatment; 2) Making qualitative improvement byintroducing the latest science and technology; 3)Promoting internationalization; 4) Making promptpartial revision as necessary and facilitating smoothadministrative operation; and 5) Ensuring transparency regarding the revision, and disseminating the JP tothe public. It was agreed that the Committee on JPshould make efforts, on the basis of these principles,to ensure that the JP is used more effectively in thefields of health care and medical treatment by takingappropriate measurements, including getting theunderstanding and cooperation of other parties concerned.It was agreed that the JP should provide an officialstandard, being required to assure the quality of medicines 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 treatment. The JP has been prepared withthe aid of the knowledge and experience of manyprofessionals in the pharmaceutical field. Therefore,the JP should have the characteristics of an officialstandard, which might be widely used by all partiesconcerned, and it should play an appropriate role ofproviding information and understanding about thequality of drugs to the public. Moreover, as a pharmaceutical quality standard, it should contributepromoting and maintaining of advancedness as well asinternational consistency and harmonization of technical requirements in the international community. Itwas also agreed that JP articles should cover drugs,which are important from the viewpoint of health careand medical treatment, clinical performance or meritsand frequency of use, as soon as possible after theyreach the market.The target date for the publication of JP 17th Edition (the Japanese edition) was set as April 2016.JP Expert Committees were originally organizedwith the following committees: Expert Committee;Sub-expert Committee; Committee on Chemicals;Committee on Antibiotics; Committee on Biologicals;Committee on Crude Drugs; Committee on Pharmaceutical Excipients; Committee on Physico-ChemicalMethods; Committee on Drug Formulation; Committee on Physical Methods; Committee on BiologicalMethods; Committee on Nomenclature for Pharmaceuticals; Committee on International Harmonization;Committee on Pharmaceutical Water and Committeeon JP Reference Standards. Furthermore, workinggroups were established under the Committee onPhysico-Chemical Methods; Committee on Drug Formulation and Committee on Biological Methods toexpedite discussion on revision drafts. Later, the Expert Committees were reorganized in order to solvetechnical issues with preparation of JP drafts; the Subcommittee on Manufacturing Process-related Matterswas newly established and the Committee on JP Reference Standards was re-formed and renamed Committee on Reference Standards. Moreover, workinggroups were established under the Committee on Pharmaceutical Excipients and Committee on InternationalHarmonization.In the Committee on JP, Mitsuru Hashida took therole of chairman from January 2011 to March 2016.In accordance with the above principles, the committees initiated deliberations on selection of articlesand on revisions for General Notices, General Rulesfor Crude Drugs, General Rules for Preparations,i
iiPrefaceGeneral Tests, Monographs and so on.In order to ensure distribution of drugs in the areahit by the 2011 off the Pacific coast of Tohoku Earthquake on March 11, 2011, for those drugs that weredistributed by the distributors in the same quake-hitarea, the expiry date of interim measure of the Supplement II to the JP 15th Edition under the MinisterialNotification No. 425 of the MHLW dated September30, 2009 was extended to June 30, 2013 and that of thePartial Revision of the JP 15th Edition under theMinisterial Notification No. 322 of the MHLW datedJuly 30, 2010 was extended to January 31, 201
previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on September 30, 2017. In the case of drugs which are listed in the new Pharmacopoeia (excluding those listed in the previous Phar-
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study as per IP, API, Unani, Pharmacopoeia, Homoeopathic Pharmacopoeia, Siddha Pharmacopoeia, BHP, Japanese Pharmacopoeia, Chinese Pharmacopoeia, European Pharmacopoeia, USP (dietary supplements), WHO and EMEA guidelines and ESCOP monographs for medicinal products. 07 Unit-4 Quanti
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