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THE JAPANESE PHARMACOPOEIA - NIHS

JP XVIITHE JAPANESE PHARMACOPOEIASEVENTEENTH EDITIONO fficial from April 1, 2016 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 between the JAPANESE original and its Englishtranslation, the former is Ministry of Health, labour andWelfare ministerial notification No. 64 Pursuant to Paragraph 1, Article 41 of theLaw on Securing Quality, Efficacy andSafety of Products including Pharmaceuticals and Medical Devices (Law No.)

The Ministry of Health, Labour and Welfare Ministerial Notification No. 64 Pursuant to Paragraph 1, Article 41 of theLaw on Securing Quality, Efficacy and

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Transcription of THE JAPANESE PHARMACOPOEIA - NIHS

1 JP XVIITHE JAPANESE PHARMACOPOEIASEVENTEENTH EDITIONO fficial from April 1, 2016 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 between the JAPANESE original and its Englishtranslation, the former is Ministry of Health, labour andWelfare ministerial notification No. 64 Pursuant to Paragraph 1, Article 41 of theLaw on Securing Quality, Efficacy andSafety of Products including Pharmaceuticals and Medical Devices (Law No.)

2 145,1960), 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 ``previ-ous 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.]

3 104, 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 Phar-macopoeia) 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, ShiozakiTheMinisterofHealth,LabourandWel fareMarch 7, 2016(The text referred to by the term ``as follows'' are omitted here.

4 All of them are madeavailable for public exhibition at the Evaluation and Licensing Division, Pharmaceu-tical Safety and Environmental Health Bureau, Ministry of Health, labour and Wel-fare, at each Regional Bureau of Health and welfare , and at each Prefectural Officein Japan).*The term ``as follows'' here indicates the contentsof the JAPANESE PHARMACOPOEIA Seventeenth Editionfrom General Notice to Ultraviolet-visible Reference Spectra (pp. 1 2405). JAPANESE PHARMACOPOEIA , Seventeenth Rules for Crude Rules for Tests, Processes and Chemical Alcohol Number Determination.

5 Ammonium Limit Test .. Chloride Limit Flame Coloration Test .. Mineral Oil Test .. Oxygen Flask Combustion Heavy Metals Limit Test .. Nitrogen Determination (Semimicro-Kjeldahl Method).. Qualitative Iron Limit Test .. Arsenic Limit Test .. Methanol Fats and Fatty Oils Sulfate Limit Readily CarbonizableSubstances Test ..412. Physical Liquid Gas Chromatography .. Thin-layer Amino Acid Analysis of Proteins ..46 Spectroscopic Nuclear Magnetic Fluorometry .. Atomic Ultraviolet-visible Infrared Physical Loss on Drying Congealing Point Determination.

6 Loss on Ignition Residue on Ignition Test .. Refractive Index Determination .. Residual Osmolarity Determination .. Water Determination (Karl FischerMethod).. Optical Rotation Determination .. Endpoint Detection Methods inTitrimetry .. Conductivity Measurement .. Thermal Viscosity Determination .. pH Vitamin A Assay .. Determination of Specific Gravity Boiling Point and Distilling RangeTest .. X-Ray Powder Diffraction Method .. Test for Total Organic Carbon .. Melting Point Turbidity Mass Inductively Coupled Plasma-AtomicEmission Spectrometry and InductivelyCoupled Plasma-Mass Spectrometry.

7 Glycosylation Analysis of Glycoprotein .. Methods for Color Powder Property Determination of Bulk and TappedDensities .. Specific Surface Area by GasAdsorption .. Powder Particle DensityDetermination .. Particle Size Determination .. Water-Solid Interactions: Determination ofSorption-Desorption Isotherms and ofWater Biological Tests/Biochemical Tests/Microbial Bacterial Endotoxins Test .. Microbial Assay for Digestion Test .. Pyrogen Microbiological Examination of Sterility Tests for Crude Crude Drugs Microbial Limit Test for Crude Drugs andPreparations containing Crude Drugs asMain Ingredient.

8 1386. Tests for Test for Metal Particles in Uniformity of Dosage Units .. Particle Size Distribution Test Test for Acid-neutralizing Capacity ofGastrointestinal Test for Extractable Volume ofParenteral Preparations .. Foreign Insoluble Matter Test forInjections ..151JP Insoluble Particulate Matter Test forInjections .. Insoluble Particulate Matter Test forOphthalmic Disintegration Test .. Dissolution Foreign Insoluble Matter Test forOphthalmic Liquids and Solutions .. Methods of Adhesion Testing .. Release Test for Preparations for Tests for Containers and Packing Test for Glass Containers for Test Methods for Plastic Test for Rubber Closure for AqueousInfusions.

9 1729. Reference Standards; Standard Solutions;Reagents, Test Solutions; MeasuringInstruments, Appliances, Reference Standards ..174 Standard Standard Solutions for VolumetricAnalysis .. Standard Solutions .. Matching Fluids for Color ..191 Reagents, Test Solutions, Reagents, Test Solid Supports/Column Packings Filter Papers, Filters for filtration,Test Papers, Crucibles, etc.. Standard Particles, Instruments and Appliances,Thermometers, Optical Filters for Wavelength andTransmission Rate Calibration .. Measuring Instruments, Thermometers.

10 356 Official Drugs and Related Reference 2222 Ultraviolet-visible Reference 2405 General InformationG1 Physics and ChemistryNear Infrared Test for Gastrointestinal Medicine ..2412 System for Trace Amounts of Aluminum inTotalParenteralNutrition(TPN)Solutions ..2414 Validation of Analytical Procedures ..2415G2 Solid-state PropertiesLaser Diffraction Measurement ofParticle Size ..2418 Measurement of the Diameter of ParticlesDispersed in Liquid by Dynamic LightScattering ..2422 Powder Fineness ..2424 Powder and Particle Biotechnological/Biological ProductsAmino Acid Analysis.


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