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JP XVIII THE JAPANESE PHARMACOPOEIA EIGHTEENTH EDITION Official from June 7, 2021 English Version
THE MINISTRY OF HEALTH, LABOUR AND WELFARE
Notice: This English Version of the Japanese Pharmacopoeia is published
for the convenience of users unfamiliar with the Japanese language. When
and if any discrepancy arises between the Japanese original and its English
translation, the former is authentic.
The Ministry of Health, Labour and
Welfare Ministerial Notification No. 220
Pursuant to Paragraph 1, Article 41 of Act on Securing Quality, Efficacy and Safety of
Products Including Pharmaceuticals and Medical Devices (Law No. 145, 1960), this notifica-
tion stated that the Japanese Pharmacopoeia was revised as follows*. TAMURA Norihisa
The Minister of Health, Labour and Welfare June 7, 2021 Japanese Pharmacopoeia
Pursuant to Paragraph 1, Article 41 of Act on Securing Quality, Efficacy and Safety of
Products Including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese
Pharmacopoeia was revised as follows.
(The text referred to by the term ``as follows'' are omitted here. All of the revised Japanese
Pharmacopoeia in accordance with this notification are made available for public exhibition
at the Pharmaceutical Evaluation 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 Office in Japan). Supplementary Provisions (Effective Date) Article 1
This Notification is applied from the date of the notification. (referred to as the
``notification date'' in the next and third articles) (Transitional measures) Article 2
In the case of drugs which are listed in the Japanese Pharmacopoeia (hereinafter
referred to as ``previous Pharmacopoeia'') and have been approved as of the notification
date as prescribed under Paragraph 1, Article 14 of Act on Securing Quality, Efficacy and
Safety of Products Including Pharmaceuticals and Medical Devices [including drugs the
Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare
Ministerial Notification No. 104, 1994) as of the day before the notification date as those
exempted from marketing approval pursuant to Paragraph 1, Article 14 of the same law
(hereinafter referred to as ``drugs exempted from approval'')], the Name and Standards es-
tablished 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 established in the
revised Japanese Pharmacopoeia (hereinafter referred to as ``new Pharmacopoeia'') (limit-
ed to part of the Name and Standards for the drugs concerned) in accordance with this
notification before and on December 31, 2022. Article 3
In the case of drugs which are listed in the new Pharmacopoeia (excluding those
listed in the previous Pharmacopoeia) and have been approved as of the notification date as
prescribed under the 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 Pharmacopoeia
before and on December 31, 2022. Article 4
In the case of drugs which are listed in the new Pharmacopoeia, their commonly
used names established in the previous Pharmacopoeia may be accepted to conform to the
Name established in the new Pharmacopoeia before and on June 30, 2024. Article 5
In the case of drugs which are listed in the new Pharmacopoeia, the previous provi-
sions are applied before and on June 30, 2024, regardless of the Paragraph 34 of General Notices.
*The term ``as follows'' here indicates the contents of the Japanese Pharmacopoeia Eighteenth Edi-
tion from General Notice to Ultraviolet-Visible Reference Spectra (pp. 1 – 2587). Contents CONTENTS 2.50 Endpoint Detection Methods in
Titrimetry .......................................69 2.51
Conductivity Measurement ....................70 2.52
Thermal Analysis.................................72 2.53
Viscosity Determination ........................75
Preface............................................................i 2.54
pH Determination................................77
The Japanese Pharmacopoeia, Eighteenth Edition ...1 2.55
Vitamin A Assay .................................79
General Notices .............................................1 2.56
Determination of Specific Gravity and
Density ...........................................80
General Rules for Crude Drugs.........................5 2.57
Boiling Point and Distilling Range
General Rules for Preparations.........................7
Test ...............................................81 2.58
X-Ray Powder Diffraction Method .........82
General Tests, Processes and Apparatus............25 2.59
Test for Total Organic Carbon ...............86 1. Chemical Methods 2.60
Melting Point Determination..................87 1.01
Alcohol Number Determination ..............25 2.61
Turbidity Measurement .........................89 1.02
Ammonium Limit Test .........................26 2.62
Mass Spectrometry...............................90 1.03
Chloride Limit Test..............................27 2.63
Inductively Coupled Plasma-Atomic 1.04
Flame Coloration Test ..........................27
Emission Spectrometry and Inductively 1.05
Mineral Oil Test ..................................28
Coupled Plasma-Mass Spectrometry .....94 1.06
Oxygen Flask Combustion Method..........28 2.64
Glycosylation Analysis of Glycoprotein ....98 1.07
Heavy Metals Limit Test .......................29 2.65
Methods for Color Matching ................100 1.08
Nitrogen Determination (Semimicro- 2.66
Elemental Impurities ...........................102
Kjeldahl Method)..............................30 3. Powder Property Determinations 1.09
Qualitative Tests..................................31 3.01
Determination of Bulk and Tapped 1.10
Iron Limit Test ...................................36
Densities........................................108 1.11
Arsenic Limit Test ...............................36 3.02 Specific Surface Area by Gas 1.12
Methanol Test.....................................38
Adsorption ....................................110 1.13
Fats and Fatty Oils Test ........................38 3.03 Powder Particle Density 1.14
Sulfate Limit Test ................................40
Determination ................................113 1.15
Readily Carbonizable Substances Test ......40 3.04
Particle Size Determination ..................114 2. Physical Methods 3.05
Water-Solid Interactions: Determination of Chromatography
Sorption-Desorption Isotherms and of 2.01
Liquid Chromatography........................41
Water Activity ................................118 2.02
Gas Chromatography ...........................44 3.06
Laser Diffraction Measurement of Particle 2.03
Thin-layer Chromatography ...................45
Size ..............................................120 2.04
Amino Acid Analysis of Proteins ............46 4.
Biological Tests/Biochemical Tests/ 2.05
Size-Exclusion Chromatography..............47 Microbial Tests Spectroscopic Methods 4.01
Bacterial Endotoxins Test ....................124 2.21 Nuclear Magnetic Resonance 4.02
Microbial Assay for Antibiotics.............127
Spectroscopy....................................48 4.03
Digestion Test ...................................131 2.22
Fluorometry .......................................50 4.04
Pyrogen Test .....................................133 2.23 Atomic Absorption 4.05
Microbiological Examination of Non-sterile
Spectrophotometry............................50
Products........................................134 2.24
Ultraviolet-visible Spectrophotometry.......51 4.06
Sterility Test......................................144 2.25
Infrared Spectrophotometry ...................53 5. Tests for Crude Drugs 2.26
Raman Spectroscopy ............................54 5.01
Crude Drugs Test ...............................147 Other Physical Methods 5.02
Microbial Limit Test for Crude Drugs and 2.41
Loss on Drying Test .............................56
Preparations containing Crude Drugs as 2.42
Congealing Point Determination .............56
Main Ingredient ..............................152 2.43
Loss on Ignition Test............................57 6. Tests for Preparations 2.44
Residue on Ignition Test .......................57 6.01
Test for Metal Particles in Ophthalmic 2.45
Refractive Index Determination ..............58
Ointments......................................161 2.46
Residual Solvents.................................58 6.02
Uniformity of Dosage Units .................161 2.47
Osmolarity Determination .....................64 6.03
Particle Size Distribution Test for 2.48
Water Determination (Karl Fischer
Preparations...................................163
Method)..........................................65 6.04
Test for Acid-neutralizing Capacity of 2.49
Optical Rotation Determination ..............68 Contents JP XVIII
Gastrointestinal Medicines.................164
Ultraviolet-visible Reference Spectra .........2399–2587 6.05 Test for Extractable Volume of General Information
Parenteral Preparations ....................164 G0
Basic Concepts on Pharmaceutical Quality 6.06
Foreign Insoluble Matter Test for
Basic Concepts for Quality Assurance of Drug
Injections ......................................165 Substances and Drug Products 6.07
Insoluble Particulate Matter Test for
.......................................................2591
Injections ......................................165
Basic Concept of Quality Risk Management 6.08
Insoluble Particulate Matter Test for
..........................................2593
Ophthalmic Solutions.......................168
Concept on Impurities in Chemically synthesized 6.09
Disintegration Test .............................169
Drug Substances and Drug Products 6.10
Dissolution Test .................................170
.......................................................2596 6.11
Foreign Insoluble Matter Test for
Stability Testing of Drug Substances and Drug
Ophthalmic Liquids and Solutions ......174
Products .............................2598 6.12
Methods of Adhesion Testing ...............175
Basic Requirements and Terms for the Packaging 6.13
Release Test for Preparations for Cutaneous
of Pharmaceutical Products ....2601
Application ....................................177
Glossary for Quality by Design (QbD), Quality 6.14
Uniformity of Delivered Dose for Inhalations
Risk Management (QRM) and Pharmaceutical
...................................................180
Quality System (PQS) ............2604 6.15
Aerodynamic Particle Size Measurement for G1 Physics and Chemistry
Inhalations.....................................183
Validation of Analytical Procedures 6.16
Rheological Measurements for Semi-solid
.......................................................2607
Preparations...................................191
System Suitability ....................2609 6.17
Insoluble Particulate Matter Test for
Near Infrared Spectrometry .......2611
Therapeutic Protein Injections ...........194 G2 Solid-state Properties 7.
Tests for Containers and Packing Materials
Solid and Particle Densities ........2614 7.01
Test for Glass Containers for Injections ..195
Powder Fineness ......................2615 7.02
Test Methods for Plastic Containers.......196
Powder Flow ..........................2616 7.03
Test for Rubber Closure for Aqueous
Measurement of the Diameter of Particles
Infusions .......................................201
Dispersed in Liquid by Dynamic Light 9.
Reference Standards; Standard Solutions;
Scattering ............................2618
Reagents, Test Solutions; Measuring G3
Biotechnological/Biological Products Instruments, Appliances, etc.
Basic Concept of the Quality Control on Reference Standards Biotechnological Products 9.01
Reference Standards ...........................203
(Biopharmaceuticals) .............2621 Standard Solutions
Amino Acid Analysis ...............2625 9.21
Standard Solutions for Volumetric
Peptide Mapping .....................2632
Analysis ........................................207
Mass Spectrometry of Peptides and Proteins 9.22
Standard Solutions .............................218
..........................................2635 9.23
Matching Fluids for Color ...................221
Monosaccharide Analysis and Oligosaccharide Reagents, Test Solutions, etc.
Analysis/Oligosaccharide Profiling 9.41
Reagents, Test Solutions ......................221
.......................................................2637 9.42
Solid Supports/Column Packings for
Isoelectric Focusing ..................2641
Chromatography .............................391
Capillary Electrophoresis ...........2643 9.43
Filter Papers, Filters for filtration,
SDS-Polyacrylamide Gel Electrophoresis
Test Papers, Crucibles, etc. ...............394
..........................................2648 9.44
Standard Particles, etc.........................394
Host Cell Protein Assay ............2653
Measuring Instruments and Appliances,
Surface Plasmon Resonance .....2656 Thermometers, etc.
Enzyme-linked Immunosorbent Assay (ELISA) 9.61
Optical Filters for Wavelength and
........................................2659
Transmission Rate Calibration ...........395
Total Protein Assay ................2662 9.62
Measuring Instruments, Appliances........395
Basic Requirements for Viral Safety of 9.63
Thermometers ...................................396
Biotechnological/Biological Products listed in
Official Monographs ......................................399
Japanese Pharmacopoeia .....2666
Crude Drugs and Related Drugs ...................1939
Mycoplasma Testing for Cell Substrates used for
the Production of Biotechnological/Biological
Infrared Reference Spectra .....................2179–2395
Products ............................2678 JP XVIII Contents
Qualification of Animals as Origin of
Aerodynamic Particle Size Measurement for
Animal-derived Medicinal Products provided
Inhalations by Glass Impingers
in the General Notices of Japanese
.......................................................2741
Pharmacopoeia and Other Standards
Tablet Hardness Determinations
........................................2682
.......................................................2743 G4 Microorganisms
Tablet Friability Test ................2744
Microbial Attributes of Non-sterile
pH Test for Gastrointestinal Medicine
Pharmaceutical Products ........2684
.......................................................2744
Control of Culture Media and Strains of
Test for Trace Amounts of Aluminum in Total
Microorganisms Used for Microbial Tests
Parenteral Nutrition (TPN) Solutions
..........................................2686
..........................................2744
Preservatives-Effectiveness Tests G7 Containers and Package
.......................................................2688
Glass Containers for Pharmaceutical Products
Bacterial Endotoxins Test and Alternative
..........................................2746
Methods using Recombinant Protein-reagents
Basic Requirements for Plastic Containers for
for Endotoxin Assay .............2691
Pharmaceutical Use and Rubber Closures for
Decision of Limit for Bacterial Endotoxins
Containers for Aqueous Infusions
..........................................2693
.......................................................2748
Rapid Microbial Methods ..........2693
Moisture Permeability Test for Blister Packaging
Rapid Identification of Microorganisms Based
of Solid Preparations ...........2749
on Molecular Biological Method
Packaging Integrity Evaluation of Sterile
.......................................................2695
Products .............................2750
Rapid Counting of Microbes using Fluorescent
Leak Tests for Packaging of Sterile Products
Staining ..............................2696
..........................................2753
Disinfection and Decontamination Methods G8 Reference Standards
..........................................2698
Reference Standards and Reference Materials
Sterilization and Sterilization Indicators
Specified in the Japanese Pharmacopoeia
........................................2701
..........................................2756 G5 Crude Drugs GZ Others
On the Scientific Names of Crude Drugs listed in
Water to be used in the Tests of Drugs
the JP ................................2707
.......................................................2758
Notification for the Quantitative Marker
Quality Control of Water for Pharmaceutical
Constituents of Crude Drugs and Crude Drug
Use ...................................2759
Preparations .......................2721
International Harmonization Implemented in the
Thin-layer Chromatography for Crude Drugs
Japanese Pharmacopoeia Eighteenth Edition and Crude Drug Preparations
.........................................2765
.......................................................2722 Appendix
Aristolochic Acid .....................2724
Atomic Weight Table (2017) ...........................2769
Quantitative Analytical Technique Utilizing
Standard Atomic Weights 2017 .......................2771
Nuclear Magnetic Resonance (NMR)
Standard Atomic Weights 2010 .......................2773
Spectroscopy and its Application to Reagents in the Japanese Pharmacopoeia
Index .........................................................2775
.......................................................2724
Index in Latin name .....................................2793
Purity Tests on Crude Drugs using Genetic
Index in Japanese.........................................2795
Information .........................2726
Analytical Methods for Aflatoxins in Crude Drug and Crude Drug Preparations
.......................................................2730
Radioactivity Measurements Method for Crude
Drugs .................................2731 G6 Drug Formulation
Criteria for Content Uniformity in Real Time
Release Testing by Process Analytical
Technology .........................2737
Standard Procedure for Mechanical Calibration
of Dissolution Apparatus .......2739 PREFACE
The Japanese Pharmacopoeia (JP) is an official
and medical treatment. The JP has been prepared with
document that defines the specifications, criteria and
the aid of the knowledge and experience of many
standard test methods necessary to properly assure the
professionals in the pharmaceutical field. Therefore, quality of medicines in Japan.
the JP should have the characteristics of an official
Paragraph 2, Article 41 of the Law on Securing
standard, which might be widely used by all parties
Quality, Efficacy and Safety of Products including
concerned, and it should play an appropriate role of
Pharmaceuticals and Medical Devices stipulates that
providing information and understanding about the
full-fledged JP revisions shall be presented at least
quality of drugs to the public. Moreover, as a phar-
every 10 years. Since the JP 9th edition, full-fledged
maceutical quality standard, it should contribute
revisions have been made every 5 years. In addition to
promoting and maintaining of advancedness as well as
the full-fledged revisions, a supplement has been
international consistency and harmonization of techni-
promulgated twice in every 5 years since the JP 12th e-
cal requirements in the international community. It
dition as well as partial revisions have been made as
was also agreed that JP articles should cover drugs,
necessary to take account of recent progress of science
which are important from the viewpoint of health care
and in the interests of international harmonization.
and medical treatment, clinical performance or merits
The 17th Edition of the JP was promulgated by
and frequency of use, as soon as possible after they
Ministerial Notification No. 64 of the Ministry of reach the market.
Health, Labour and Welfare (MHLW) on March 7,
The target date for the publication of the JP 18th 2016.
Edition (the Japanese edition) was set as April 2021.
In July 2016, the Committee on JP established the
JP drafts are discussed in the following committees
basic principles for the preparation of the JP 18th Edi-
that were established in the Pharmaceuticals and Med-
tion, setting out the roles and characteristics of the JP,
ical Devices Agency: Expert Committee; Sub-expert
the definite measures for the revision, and the date of
Committee; Sub-committee on Manufacturing Proc- the revision.
ess-related Matters; Committee on Chemicals; Com-
At the Committee, the five basic principles of JP,
mittee on Antibiotics; Committee on Biologicals;
which we refer to as the ``five pillars'', were estab-
Committee on Crude Drugs; Committee on Phar-
lished as follows: 1) Including all drugs which are im-
maceutical Excipients; Committee on Physico-Chemi-
portant from the viewpoint of health care and medical
cal Methods; Committee on Drug Formulation; Com-
treatment; 2) Making qualitative improvement by in-
mittee on Physical Methods; Committee on Biological
troducing the latest science and technology; 3)
Methods; Committee on Nomenclature for Phar-
Promoting further internationalization in response to
maceuticals; Committee on International Harmoniza-
globalization of drug market; 4) Making prompt par-
tion; and Committee on Reference Standards.
tial revision as necessary and facilitating smooth ad-
In the Committee on JP, Mitsuru Hashida took the
ministrative operation; and 5) Ensuring transparency
role of chairman from April 2016 to June 2021.
regarding the revision, and disseminating the JP to the
In accordance with the above principles, the com-
public. It was agreed that the Committee on JP should
mittees initiated deliberations on selection of articles
make efforts, on the basis of these principles, to en-
and on revisions for General Notices, General Rules
sure that the JP is used more effectively in the fields of
for Crude Drugs, General Rules for Preparations,
health care and medical treatment by taking appropri-
General Tests, Monographs and so on.
ate measurements, including getting the understanding
Draft revisions covering subjects in General Rules
and cooperation of other parties concerned.
for Preparations, General Tests and Monographs, for
It was agreed that the JP should provide an official
which discussions were finished between August 2015
standard, being required to assure the quality of medi-
and March 2017, were prepared for a supplement to
cines in Japan in response to the progress of science
the JP 17. The draft revisions were examined by the
and technology and medical demands at the time. It
Committee on JP in April 2017, followed by the Phar-
should define the standards for specifications, as well
maceutical Affairs and Food Sanitation Council
as the methods of testing to assure overall quality of
(PAFSC) in June 2017, and then submitted to the
all drugs in principle, and it should have a role in
Minister of Health, Labour and Welfare.
clarifying the criteria for quality assurance of drugs
The supplement was named ``Supplement I to the
that are recognized to be essential for public health
JP 17th Edition'', promulgated on December 1, 2017 i ii Preface JP XVIII
by Ministerial Notification No. 348 of MHLW, and
tibiotics (3); Committee on Biologicals (7); Committee became effective.
on Crude Drugs (15); Committee on Pharmaceutical
Numbers of discussions in the committees to pre-
Excipients (10); Committee on Physico-Chemical
pare the supplement drafts were as follows: Expert
Methods (11, including working group); Committee
Committee (8); Sub-committee on Manufacturing Pro-
on Drug Formulation (19, including working group);
cess-related Matters (9); Committee on Chemicals
Committee on Physical Methods (7); Committee on
(20); Committee on Antibiotics (5); Committee on
Biological Methods (6); Committee on Nomenclature
Biologicals (8); Committee on Crude Drugs (17); Com-
for Pharmaceuticals (5); and Committee on Interna-
mittee on Pharmaceutical Excipients (10); Committee tional Harmonization (4).
on Physico-Chemical Methods (14, including working
It should be noted that in the preparation of the
group); Committee on Drug Formulation (27, includ-
drafts for the supplement, generous cooperation was
ing working group); Committee on Physical Methods
given by the Pharmaceutical Technology Committee
(8); Committee on Biological Methods (6); Committee
of the Kansai Pharmaceutical Industries Association,
on Nomenclature for Pharmaceuticals (7); Committee
the Pharmacopeia and CMC Committee of the Phar-
on International Harmonization (6); and Committee
maceutical Manufacturers' Association of Tokyo, the on Reference Standards (4).
Tokyo Crude Drugs Association, the International
It should be noted that in the preparation of the
Pharmaceutical Excipients Council Japan, the Home
drafts for the supplement, generous cooperation was
Medicine Association of Japan, the Japan Kampo
given by the Pharmaceutical Technology Committee
Medicines Manufacturers Association, the Japan
of the Osaka Pharmaceutical Manufacturers Associa-
Flavor and Fragrance Materials Association, the
tion, the Pharmacopeia and CMC Committee of the
Japan Medicinal Plant Federation, the Japan Phar- Pharmaceutical Manufacturers' Association of
maceutical Manufacturers Association, the Federation
Tokyo, the Tokyo Crude Drugs Association, the Inter-
of Pharmaceutical Manufacturers' Association of
national Pharmaceutical Excipients Council Japan,
Japan, the Parenteral Drug Association Japan Chap-
the Home Medicine Association of Japan, the Japan
ter, the Japan Reagent Association, the Japan Oilseed
Kampo Medicines Manufacturers Association, the
Processors Association, the Japan Analytical Instru-
Japan Flavor and Fragrance Materials Association,
ments Manufacturers' Association, and the Asian So-
the Japan Medicinal Plant Federation, the Japan
ciety of Innovative Packaging Technology. Pharmaceutical Manufacturers Association, the
In consequence of this revision, the JP 17th Edition
Federation of Pharmaceutical Manufacturers' Associ-
carries 2008 articles, owing to the addition of 34 arti-
ation of Japan, the Parenteral Drug Association Japan
cles and the deletion of 3 articles.
Chapter, the Japan Reagent Association, the Japan
Draft revisions covering subjects in General Notices,
Oilseed Processors Association, the Japan Analytical
General Rules for Crude Drugs, General Rules for
Instruments Manufacturers' Association, and the Asi-
Preparations, General Tests and Monographs, for
an Society of Innovative Packaging Technology.
which discussions were finished between December
In consequence of this revision, the JP 17th Edition
2018 and August 2020, were prepared for a supple-
carries 1977 articles, owing to the addition of 32 arti-
ment to the JP 18. The draft revisions were examined
cles and the deletion of 17 articles.
by the Committee on JP in October 2020, followed by
Draft revisions covering subjects in General Notices,
the PAFSC in December 2020, and then submitted to
General Rules for Preparations, General Tests and
the Minister of Health, Labour and Welfare.
Monographs, for which discussions were finished be-
Numbers of discussions in the committees to pre-
tween April 2017 and November 2018, were prepared
pare the revision drafts were as follows: Expert Com-
for a supplement to the JP 17. The draft revisions
mittee (12, including working group); Committee on
were examined by the Committee on JP in January
Chemicals (19); Committee on Antibiotics (3); Com-
2019, followed by the PAFSC in March 2019, and then
mittee on Biologicals (8); Committee on Crude Drugs
submitted to the Minister of Health, Labour and Wel-
(14); Committee on Pharmaceutical Excipients (10, fare.
including working group); Committee on Physico-
The supplement was named ``Supplement II to the
Chemical Methods (7); Committee on Drug Formula-
JP 17th Edition'', promulgated on June 28, 2019 by
tion (20, including working group); Committee on
Ministerial Notification No. 49 of MHLW, and
Physical Methods (7); Committee on Biological became effective.
Methods (7); Committee on Nomenclature for Phar-
Numbers of discussions in the committees to pre-
maceuticals (6); Committee on International Harmoni-
pare the supplement drafts were as follows: Expert
zation (7); and Committee on Reference Standards (7,
Committee (11, including working group); Subcom- including working group).
mittee on Manufacturing Process-related Matters (6);
It should be noted that in the preparation of the re-
Committee on Chemicals (18); Committee on An-
vision drafts, generous cooperation was given by the JP XVIII Preface iii
Pharmaceutical Technology Committee of the Kansai (16)
Specific physical and/or chemical values
Pharmaceutical Industries Association, the Pharmaco- (17) Purity tests
peia and CMC Committee of the Pharmaceutical (18) Potential adulteration
Manufacturers' Association of Tokyo, the Tokyo (19)
Loss on drying or Ignition, or Water
Crude Drugs Association, the International Phar- (20)
Residue on ignition, Total ash or Acid-insoluble
maceutical Excipients Council Japan, the Home Medi- ash
cine Association of Japan, the Japan Kampo Medi- (21)
Tests being required for pharmaceutical prepa-
cines Manufacturers Association, the Japan Flavor rations
and Fragrance Materials Association, the Japan (22) Other special tests
Medicinal Plant Federation, the Japan Pharmaceutical (23) Assay
Manufacturers Association, the Federation of Phar- (24) Containers and storage
maceutical Manufacturers' Association of Japan, the (25) Shelf life
Parenteral Drug Association Japan Chapter, the (26) Others
Japan Reagent Association, the Japan Oilseed Proces- 4.
In each monograph, the following physical and
sors Association, the Japan Analytical Instruments
chemical values representing the properties and quality
Manufacturers' Association, and the Asian Society of
of the drug are given in the order indicated below, ex-
Innovative Packaging Technology.
cept that unnecessary items are omitted depending on
In consequence of this revision, the JP 18th Edition the nature of drug:
carries 2033 articles, owing to the addition of 33 arti- (1) Alcohol number
cles and the deletion of 8 articles. (2) Absorbance
The principles of description and the salient points (3) Congealing point
of the revision in this volume are as follows: (4) Refractive index 1.
The JP 18th Edition comprises the following (5) Osmolar ratio
items, in order: Notification of MHLW; Contents; (6) Optical rotation
Preface; General Notices; General Rules for Crude (7) Constituent amino acids
Drugs; General Rules for Preparations; General Tests, (8) Viscosity
Processes and Apparatus; Official Monographs; then (9) pH
followed by Infrared Reference Spectra and Ultravio- (10)
Content ratio of the active ingredients
let-visible Reference Spectra; General Information; (11) Specific gravity
Table of Standard Atomic Weights as an appendix; (12) Boiling point and a Cumulative Index. (13) Melting point (14) Acid value 2.
The articles in Official Monographs, Infrared (15) Saponification value
Reference Spectra and Ultraviolet-visible Reference (16) Ester value
Spectra are respectively placed in alphabetical order in (17) Hydroxyl value principle. (18) Iodine value 3.
The following items in each monograph are put 5.
Identification tests comprise the following
in the order shown below, except that unnecessary
items, which are generally put in the order given
items are omitted depending on the nature of the drug: below: (1) English title (1) Coloration reactions (2) Commonly used name(s) (2) Precipitation reactions (3)
Latin title (only for crude drugs) (3) Decomposition reactions (4) Title in Japanese (4) Derivatives (5)
Structural formula or empirical formula (5)
Infrared and/or ultraviolet-visible absorption (6)
Molecular formula and molecular mass spectrometry (7) Chemical name (6)
Nuclear magnetic resonance spectrometry (8)
Chemical Abstracts Service (CAS) Registry (7) Chromatography Number (8) Special reactions (9) Origin (9) Cations (10)
Limits of the content of the ingredient(s) and/or (10) Anions the unit of potency (11) Labeling requirements 6.
Purity tests comprise the following items, which (12) Method of preparation
are generally put in the order given below, except that (13) Manufacture
unnecessary items are omitted depending on the nature (14) Description of drug: (15) Identification tests (1) Color iv Preface JP XVIII (2) Odor
masses of the elements whose atomic weight is (3)
Clarity and/or color of solution
indicated with an interval in the 2015 table were (4) Acidity or alkalinity
determined to conform to the table of ``Atomic (5) Acidity
Weights of the Elements 2007'' (IUPAC). (6) Alkalinity 9.
The following item was newly added to General (7) Chloride
Tests, Processes and Apparatus: (8) Sulfate (1)
2.05 Size-Exclusion Chromatography (9) Sulfite (10) Nitrate 10.
The following items in General Tests, Pro- (11) Nitrite
cesses and Apparatus were revised: (12) Carbonate (1) Preamble (13) Bromide (2) 2.46 Residual Solvents (14) Iodide (3) 2.48 Water Determination (15) Soluble halide (4) 2.51 Conductivity Measurement (16) Thiocyanate (5) 2.52 Thermal Analysis (17) Selenium (6) 2.66 Elemental Impurities (18) Cationic salts (7) 4.06 Sterility Test (19) Ammonium (8) 5.01 Crude Drugs Test (20) Heavy metals (9) 9.01 Reference Standards (21) Iron (10) 9.41 Reagents, Test Solutions (22) Manganese (11)
9.62 Measuring Instruments, Appliances (23) Chromium 11.
The following Reference Standards were (24) Bismuth added: (25) Tin Bicalutamide RS (26) Aluminum Cabergoline RS (27) Zinc Celecoxib RS (28) Cadmium Eribulin Mesilate RS (29) Mercury
Eribulin Mesilate Related Substance C for System (30) Copper Suitability RS (31) Lead Ethyl Loflazepate RS (32) Silver Fenofibrate RS (33) Alkaline earth metals Gefitinib RS (34) Arsenic Glucagon RS (35) Free phosphoric acid Rilmazafone Hydrochloride RS (36) Foreign matters Rosuvastatin Calcium RS (37) Related substances Saccharin RS (38) Isomer Timolol Maleate RS (39) Enantiomer Triazolam RS (40) Diastereomer (41) Polymer 12.
The following Reference Standard was revised (42) Residual solvent in Japanese title: (43) Other impurities Saccharin Sodium RS (44) Residue on evaporation 13.
The following Reference Standards were de- (45)
Readily carbonizable substances
leted from the list of ``9.01 (2) The reference standards 7.
The following paragraph was newly added to
which are prepared by National Institute of Infectious General Notices:
Diseases'' and added to the list of ``9.01 (1) The refer- (1)
Paragraph 34: The provision for elemental im-
ence standards which are prepared by those who have
purities based on ICH Q3D ``Guideline for
been registered to prepare them by the Minister of
Elemental Impurities'' was added.
Health, Labour and Welfare, according to the
Ministerial ordinance established by the Minister sepa- 8.
The following paragraph of General Notices rately'': was revised: Cefepime Dihydrochloride RS (1)
Paragraph 8: Atomic masses adopted in the Cefotiam Hydrochloride RS
Japanese Pharmacopoeia were determined to Ceftriaxone Sodium RS
conform to the table of ``Atomic Weights of the Clarithromycin RS
Elements 2015'' (IUPAC), however, the atomic Epirubicin Hydrochloride RS JP XVIII Preface v Minocycline Hydrochloride RS
Celmoleukin (Genetical Recombination) Piperacillin RS Clinofibrate Roxithromycin RS Clopidogrel Sulfate Sulbactam RS
Colistin Sodium Methanesulfonate Tazobactam RS Dihydroergotoxine Mesilate Vancomycin Hydrochloride RS Dimorpholamine Diphenhydramine 14.
The following substances were newly added to Diphenhydramine Hydrochloride the Official Monographs: Distigmine Bromide Bicalutamide Dorzolamide Hydrochloride Cabergoline Enviomycin Sulfate Celecoxib
Epoetin Alfa (Genetical Recombination) Cloperastine Fendizoate
Epoetin Beta (Genetical Recombination)
Cloperastine Fendizoate Tablets Ergometrine Maleate Copovidone Ethambutol Hydrochloride
Dorzolamide Hydrochloride and Timolol Maleate Ethyl Aminobenzoate Ophthalmic Solution
Filgrastim (Genetical Recombination) Eribulin Mesilate Fradiomycin Sulfate Ethyl Loflazepate Gelatin Ethyl Loflazepate Tablets Purified Gelatin Fenofibrate Gentamicin Sulfate Fenofibrate Tablets Glucose Injection Fludiazepam Tablets Human Menopausal Gonadotrophin Gefitinib Heparin Calcium
Glucagon (Genetical Recombination) Heparin Sodium Heparin Sodium Lock Solution
Low Substituted Hydroxypropylcellulose
Heparin Sodium Solution for Dialysis Hypromellose
Irinotecan Hydrochloride Injection
Insulin Human (Genetical Recombination) Methotrexate for Injection
Insulin Aspart (Genetical Recombination) Miglitol Tablets
Insulin Glargine (Genetical Recombination) Phenobarbital Tablets Kallidinogenase
Pitavastatin Calcium Orally Disintegrating Tablets Kitasamycin Acetate
Rilmazafone Hydrochloride Hydrate Kitasamycin Tartrate
Rilmazafone Hydrochloride Tablets Anhydrous Lactose Rosuvastatin Calcium Lactose Hydrate Rosuvastatin Calcium Tablets Lauromacrogol
Silodosin Orally Disintegrating Tablets
Lenograstim (Genetical Recombination)
Telmisartan and Amlodipine Besilate Tablets Levofloxacin Hydrate Triazolam Levofloxacin Fine Granules Zopiclone Levofloxacin Injection Zopiclone Tablets Levofloxacin Tablets Byakkokaninjinto Extract Lysozyme Hydrochloride Unseiin Extract Methylcellulose 15.
The following monographs were revised: Methylergometrine Maleate Aprindine Hydrochloride Mexiletine Hydrochloride Azathioprine Tablets Montelukast Sodium Bepotastine Besilate Nafamostat Mesilate Bleomycin Hydrochloride
Nartograstim (Genetical Recombination) Bleomycin Sulfate
Norgestrel and Ethinylestradiol Tablets Calcitonin Salmon Olmesartan Medoxomil Calcium Folinate Hydrate Oxybuprocaine Hydrochloride
Calcium Paraaminosalicylate Hydrate Oxygen Carmellose Calcium Oxytocin Carmellose Sodium
Paroxetine Hydrochloride Hydrate Croscarmellose Sodium Pitavastatin Calcium Hydrate Cefoperazone Sodium Pitavastatin Calcium Tablets vi Preface JP XVIII Polymixin B Sulfate Jujube Seed Povidone Kamikihito Extract Povidone-Iodine Kamishoyosan Extract Protamine Sulfate Keishibukuryogan Extract Pullulan Lilium Bulb Saccharin Lycium Fruit Saccharin Sodium Hydrate Magnolia Bark Scopolamine Butylbromide Powdered Magnolia Bark
Scopolamine Hydrobromide Hydrate Mentha Oil Purified Shellac Moutan Bark White Shellac Powdered Moutan Bark Silodosin Nelumbo Seed Silodosin Tablets Notopterygium Sodium Lauryl Sulfate Nuphar Rhizome Wheat Starch Nutmeg Sucrose Nux Vomica
Teceleukin (Genetical Recombination) Nux Vomica Extract Powder Tetracaine Hydrochloride Orengedokuto Extract Valaciclovir Hydrochloride Perilla Herb Valsartan Peucedanum Root Vasopressin Injection Phellodendron Bark Voriconazole Powdered Phellodendron Bark Voriconazole for Injection Plantago Herb Alpinia Officinarum Rhizome Plantago Seed Asiasarum Root Pogostemon Herb Asparagus Root Polyporus Sclerotium Atractylodes Lancea Rhizome Powdered Polyporus Sclerotium Bearberry Leaf Poria Sclerotium Belladonna Root Powdered Poria Sclerotium Bupleurum Root Pueraria Root Cardamon Quercus Bark Cinnamon Bark Ryokeijutsukanto Extract Cinnamon Oil Saffron Clove Salvia Miltiorrhiza Root Powdered Clove Sappan Wood Cnidium Rhizome Scopolia Rhizome Powdered Cnidium Rhizome Scopolia Extract Powder Coptis Rhizome
Scopolia Extract and Ethyl Aminobenzoate Powder Powdered Coptis Rhizome Sophora Root Cornus Fruit Powdered Sophora Root Curcuma Rhizome Toad Cake Dioscorea Rhizome Tokakujokito Extract Ephedra Herb Trichosanthes Root Euodia Fruit Uncaria Hook Gardenia Fruit 16.
A part or all of the commonly used names Powdered Gardenia Fruit
were deleted from the following monographs (chemi- Glycyrrhiza cal drugs, etc): Goreisan Extract Acebutolol Hydrochloride Goshuyuto Extract Acetazolamide Hangekobokuto Extract
Acetylcholine Chloride for Injection Houttuynia Herb Acetylcysteine Imperata Rhizome Aclarubicin Hydrochloride Ipecac Syrup Acrinol Hydrate Powdered Japanese Gentian Adrenaline Injection Japanese Zanthoxylum Peel Adrenaline Solution
Powdered Japanese Zanthoxylum Peel Afloqualone JP XVIII Preface vii Aldioxa Betamethasone Dipropionate Aldioxa Granules Betamethasone Sodium Phosphate Aldioxa Tablets Betamethasone Valerate Alimemazine Tartrate
Betamethasone Valerate and Gentamicin Sulfate Alprenolol Hydrochloride Cream Alprostadil
Betamethasone Valerate and Gentamicin Sulfate Alprostadil Alfadex Ointment
Aluminum Potassium Sulfate Hydrate Betaxolol Hydrochloride Amantadine Hydrochloride Bethanechol Chloride Ambenonium Chloride Bifonazole Amikacin Sulfate Biperiden Hydrochloride Amikacin Sulfate for Injection Bismuth Subgallate Amikacin Sulfate Injection Bisoprolol Fumarate Aminophylline Hydrate Bisoprolol Fumarate Tablets Amiodarone Hydrochloride Bleomycin Hydrochloride
Amiodarone Hydrochloride Tablets Bleomycin Sulfate Amitriptyline Hydrochloride
Freeze-dried Botulism Antitoxin, Equine
Amitriptyline Hydrochloride Tablets Bromhexine Hydrochloride Amlodipine Besilate Bromocriptine Mesilate Amlodipine Besilate Tablets Bufetolol Hydrochloride Amosulalol Hydrochloride Buformin Hydrochloride
Amosulalol Hydrochloride Tablets
Buformin Hydrochloride Delayed-release Tablets Amoxicillin Hydrate Buformin Hydrochloride Tablets Anhydrous Ampicillin Bunazosin Hydrochloride Ampicillin Hydrate
Bupivacaine Hydrochloride Hydrate Ampicillin Sodium Buprenorphine Hydrochloride Aprindine Hydrochloride Butenafine Hydrochloride
Aprindine Hydrochloride Capsules Butenafine Hydrochloride Cream Arbekacin Sulfate
Butenafine Hydrochloride Solution Arbekacin Sulfate Injection Butenafine Hydrochloride Spray Argatroban Hydrate Butropium Bromide L-Arginine Hydrochloride Caffeine and Sodium Benzoate
L-Arginine Hydrochloride Injection Caffeine Hydrate Arotinolol Hydrochloride Calcitonin Salmon Arsenic Trioxide
Precipitated Calcium Carbonate Fine Granules Aspoxicillin Hydrate
Precipitated Calcium Carbonate Tablets Atropine Sulfate Hydrate Calcium Chloride Hydrate Atropine Sulfate Injection Calcium Folinate Hydrate Azelastine Hydrochloride Calcium Gluconate Hydrate
Azelastine Hydrochloride Granules Calcium Hydroxide Bacampicillin Hydrochloride Calcium Lactate Hydrate Beclometasone Dipropionate Calcium Levofolinate Hydrate Bekanamycin Sulfate Calcium Oxide Benidipine Hydrochloride
Calcium Paraaminosalicylate Hydrate
Benidipine Hydrochloride Tablets
Dibasic Calcium Phosphate Hydrate Benserazide Hydrochloride
Monobasic Calcium Phosphate Hydrate Benzalkonium Chloride Calcium Sodium Edetate Hydrate
Benzalkonium Chloride Concentrated Solution 50 Camostat Mesilate Benzalkonium Chloride Solution
Carbazochrome Sodium Sulfonate Hydrate Benzethonium Chloride Carbidopa Hydrate Benzethonium Chloride Solution Carbon Dioxide
Benzylpenicillin Benzathine Hydrate Carteolol Hydrochloride Benzylpenicillin Potassium Cefadroxil for Syrup Berberine Chloride Hydrate Cefalexin for Syrup Betahistine Mesilate
Cefatrizine Propylene Glycolate for Syrup Betahistine Mesilate Tablets
Cefcapene Pivoxil Hydrochloride Hydrate viii Preface JP XVIII
Cefcapene Pivoxil Hydrochloride Fine Granules Clobetasol Propionate
Cefcapene Pivoxil Hydrochloride Tablets
Clocapramine Hydrochloride Hydrate Cefditoren Pivoxil Clofedanol Hydrochloride
Cefditoren Pivoxil Fine Granules Clomifene Citrate Cefditoren Pivoxil Tablets Clomifene Citrate Tablets
Cefepime Dihydrochloride Hydrate Clomipramine Hydrochloride
Cefepime Dihydrochloride for Injection Clonidine Hydrochloride Cefixime Hydrate Cloperastine Hydrochloride Cefmenoxime Hydrochloride Cloxacillin Sodium Hydrate Cefminox Sodium Hydrate Cocaine Hydrochloride Cefotiam Hydrochloride Codeine Phosphate Hydrate
Cefotiam Hydrochloride for Injection 1z Codeine Phosphate Powder Cefozopran Hydrochloride 10z Codeine Phosphate Powder
Cefozopran Hydrochloride for Injection Codeine Phosphate Tablets Cefpirome Sulfate Colestimide Cefpodoxime Proxetil Colistin Sulfate Cefpodoxime Proxetil for Syrup Cortisone Acetate Cefroxadine Hydrate Croconazole Hydrochloride Cefroxadine for Syrup Cyclopentolate Hydrochloride Ceftazidime Hydrate Cyclophosphamide Hydrate Cefteram Pivoxil
Cyproheptadine Hydrochloride Hydrate Cefteram Pivoxil Fine Granules Dantrolene Sodium Hydrate Cefteram Pivoxil Tablets Daunorubicin Hydrochloride Ceftibuten Hydrate Deferoxamine Mesilate Ceftriaxone Sodium Hydrate Dehydrocholic Acid Injection Cefuroxime Axetil
Demethylchlortetracycline Hydrochloride Cetirizine Hydrochloride
Dextran Sulfate Sodium Sulfur 5
Cetirizine Hydrochloride Tablets
Dextran Sulfate Sodium Sulfur 18
Cetotiamine Hydrochloride Hydrate
Dextromethorphan Hydrobromide Hydrate Cetraxate Hydrochloride Dibekacin Sulfate
Chloramphenicol Sodium Succinate
Dibekacin Sulfate Ophthalmic Solution
Chlorhexidine Gluconate Solution Dibucaine Hydrochloride Chlorhexidine Hydrochloride Dicloxacillin Sodium Hydrate Chlormadinone Acetate Diethylcarbamazine Citrate Chlorphenesin Carbamate
Diethylcarbamazine Citrate Tablets
Chlorphenesin Carbamate Tablets Difenidol Hydrochloride Chlorpheniramine Maleate Diflorasone Diacetate
Chlorpheniramine Maleate Injection Diflucortolone Valerate
Chlorpheniramine Maleate Powder Dihydrocodeine Phosphate
Chlorpheniramine Maleate Tablets
1z Dihydrocodeine Phosphate Powder d-Chlorpheniramine Maleate
10z Dihydrocodeine Phosphate Powder Chlorpromazine Hydrochloride Dihydroergotamine Mesilate
Chlorpromazine Hydrochloride Injection Dihydroergotoxine Mesilate
Chlorpromazine Hydrochloride Tablets Dilazep Hydrochloride Hydrate Cibenzoline Succinate Diltiazem Hydrochloride Cibenzoline Succinate Tablets Dimemorfan Phosphate Ciclosporin Dinoprost Cilazapril Hydrate Diphenhydramine Hydrochloride
Ciprofloxacin Hydrochloride Hydrate
Diphenhydramine and Bromovalerylurea Powder Citric Acid Hydrate
Freeze-dried Diphtheria Antitoxin, Equine Clebopride Malate Distigmine Bromide Clemastine Fumarate Distigmine Bromide Tablets Clindamycin Hydrochloride Dobutamine Hydrochloride
Clindamycin Hydrochloride Capsules Donepezil Hydrochloride Clindamycin Phosphate
Donepezil Hydrochloride Fine Granules
Clindamycin Phosphate Injection
Donepezil Hydrochloride Tablets JP XVIII Preface ix Dopamine Hydrochloride
Gentamicin Sulfate Ophthalmic Solution
Dopamine Hydrochloride Injection Glutathione Doxapram Hydrochloride Hydrate Glyceryl Monostearate Doxazosin Mesilate Glycine Doxazosin Mesilate Tablets Gonadorelin Acetate Doxorubicin Hydrochloride Guaifenesin
Doxorubicin Hydrochloride for Injection Guanabenz Acetate
Doxycycline Hydrochloride Hydrate
Freeze-dried Habu Antivenom, Equine
Doxycycline Hydrochloride Tablets
L-Histidine Hydrochloride Hydrate Ecabet Sodium Hydrate Homatropine Hydrobromide Emedastine Fumarate
Homochlorcyclizine Hydrochloride Enalapril Maleate Hydralazine Hydrochloride Enalapril Maleate Tablets
Hydralazine Hydrochloride for Injection Enviomycin Sulfate
Hydralazine Hydrochloride Powder Eperisone Hydrochloride
Hydralazine Hydrochloride Tablets Ephedrine Hydrochloride Hydrocortisone Acetate
Ephedrine Hydrochloride Injection Hydrocortisone Butyrate
10z Ephedrine Hydrochloride Powder
Hydrocortisone Sodium Phosphate
Ephedrine Hydrochloride Tablets
Hydrocortisone Sodium Succinate Epirizole Hydrocortisone Succinate Epirubicin Hydrochloride
Hydrocotarnine Hydrochloride Hydrate Ergocalciferol Hydroxocobalamin Acetate Ergometrine Maleate Hydroxyzine Hydrochloride Ergometrine Maleate Injection Hydroxyzine Pamoate Ergometrine Maleate Tablets Hypromellose Ergotamine Tartrate Hypromellose Acetate Succinate Erythromycin Ethylsuccinate Hypromellose Phthalate Erythromycin Lactobionate Idarubicin Hydrochloride Erythromycin Stearate
Idarubicin Hydrochloride for Injection Estradiol Benzoate Ifenprodil Tartrate
Estradiol Benzoate Injection (Aqueous Suspension)
Ifenprodil Tartrate Fine Granules Ethambutol Hydrochloride Ifenprodil Tartrate Tablets Ethenzamide Imidapril Hydrochloride Ethyl L-Cysteine Hydrochloride
Imidapril Hydrochloride Tablets
Ethylmorphine Hydrochloride Hydrate Imipenem Hydrate Etilefrine Hydrochloride Imipramine Hydrochloride
Etilefrine Hydrochloride Tablets
Imipramine Hydrochloride Tablets Faropenem Sodium Hydrate
Insulin Human (Genetical Recombination) Fentanyl Citrate
Insulin Human (Genetical Recombination) Injection Ferrous Sulfate Hydrate Ipratropium Bromide Hydrate Fexofenadine Hydrochloride Irsogladine Maleate Flavoxate Hydrochloride
Irsogladine Maleate Fine Granules Flecainide Acetate Irsogladine Maleate Tablets Flecainide Acetate Tablets Isepamicin Sulfate Fludrocortisone Acetate Isepamicin Sulfate Injection Flurazepam Hydrochloride l-Isoprenaline Hydrochloride Fluvoxamine Maleate Isosorbide Dinitrate Fluvoxamine Maleate Tablets Isosorbide Dinitrate Tablets Formoterol Fumarate Hydrate
Isosorbide Mononitrate 70z/Lactose 30z Fosfomycin Calcium Hydrate Isoxsuprine Hydrochloride Fradiomycin Sulfate
Isoxsuprine Hydrochloride Tablets Fursultiamine Hydrochloride Josamycin Propionate Gabexate Mesilate Kainic Acid Hydrate b-Galactosidase (Aspergillus) Kanamycin Monosulfate b-Galactosidase (Penicillium) Kanamycin Sulfate Gentamicin Sulfate Ketamine Hydrochloride x Preface JP XVIII Ketoconazole Solution Midecamycin Acetate Ketotifen Fumarate Minocycline Hydrochloride Kitasamycin
Minocycline Hydrochloride for Injection Kitasamycin Acetate
Minocycline Hydrochloride Tablets Kitasamycin Tartrate Morphine Hydrochloride Hydrate Labetalol Hydrochloride
Morphine Hydrochloride Injection
Labetalol Hydrochloride Tablets Morphine Hydrochloride Tablets Lactose Hydrate
Morphine and Atropine Injection Lauromacrogol Morphine Sulfate Hydrate Lenampicillin Hydrochloride Mosapride Citrate Hydrate Levallorphan Tartrate Mosapride Citrate Powder
Levallorphan Tartrate Injection Mosapride Citrate Tablets Levofloxacin Hydrate Mupirocin Calcium Hydrate Levomepromazine Maleate Nafamostat Mesilate Levothyroxine Sodium Hydrate Naloxone Hydrochloride Lidocaine Injection Naphazoline Hydrochloride Limaprost Alfadex Naphazoline Nitrate
Lincomycin Hydrochloride Hydrate Neostigmine Methylsulfate
Lincomycin Hydrochloride Injection
Neostigmine Methylsulfate Injection Lisinopril Hydrate Nicardipine Hydrochloride Lobenzarit Sodium
Nicardipine Hydrochloride Injection Loxoprofen Sodium Hydrate Noradrenaline Injection L-Lysine Acetate Noscapine L-Lysine Hydrochloride
Noscapine Hydrochloride Hydrate Lysozyme Hydrochloride Olopatadine Hydrochloride Magnesium Sulfate Hydrate
Olopatadine Hydrochloride Tablets Maltose Hydrate Opium Alkaloids Hydrochlorides
Freeze-dried Mamushi Antivenom, Equine
Opium Alkaloids Hydrochlorides Injection Manidipine Hydrochloride
Opium Alkaloids and Atropine Injection
Manidipine Hydrochloride Tablets
Opium Alkaloids and Scopolamine Injection D-Mannitol
Weak Opium Alkaloids and Scopolamine Injection D-Mannitol Injection Orciprenaline Sulfate Maprotiline Hydrochloride Oxapium Iodide Meclofenoxate Hydrochloride Oxprenolol Hydrochloride Mefloquine Hydrochloride Oxybuprocaine Hydrochloride Mepenzolate Bromide
Oxycodone Hydrochloride Hydrate Mepivacaine Hydrochloride Compound Oxycodone Injection
Mepivacaine Hydrochloride Injection
Compound Oxycodone and Atropine Injection Mercaptopurine Hydrate Oxytetracycline Hydrochloride Meropenem Hydrate Pancuronium Bromide Metenolone Acetate Papaverine Hydrochloride Metenolone Enanthate
Papaverine Hydrochloride Injection Metenolone Enanthate Injection
Paroxetine Hydrochloride Hydrate Metformin Hydrochloride Pentoxyverine Citrate
Metformin Hydrochloride Tablets Peplomycin Sulfate Methylbenactyzium Bromide
Peplomycin Sulfate for Injection Methyldopa Hydrate Perphenazine Maleate
dl-Methylephedrine Hydrochloride Perphenazine Maleate Tablets
10z dl-Methylephedrine Hydrochloride Powder Pethidine Hydrochloride Methylergometrine Maleate
Pethidine Hydrochloride Injection
Methylergometrine Maleate Tablets 10z Phenobarbital Powder Metoprolol Tartrate Phenol Metoprolol Tartrate Tablets Phenol and Zinc Oxide Liniment Mexiletine Hydrochloride Phenylephrine Hydrochloride Miconazole Nitrate Phenytoin Micronomicin Sulfate Phenytoin Powder JP XVIII Preface xi Phenytoin Tablets Riboflavin Butyrate Phenytoin Sodium for Injection Riboflavin Sodium Phosphate Phytonadione
Riboflavin Sodium Phosphate Injection Pilocarpine Hydrochloride Ribostamycin Sulfate
Pilocarpine Hydrochloride Tablets Ritodrine Hydrochloride Pioglitazone Hydrochloride
Ritodrine Hydrochloride Tablets
Pioglitazone Hydrochloride Tablets
Roxatidine Acetate Hydrochloride Pipemidic Acid Hydrate
Roxatidine Acetate Hydrochloride Extended-release Piperazine Phosphate Hydrate Capsules Piperazine Phosphate Tablets
Roxatidine Acetate Hydrochloride Extended-release
Pirenzepine Hydrochloride Hydrate Tablets Pitavastatin Calcium Hydrate
Roxatidine Acetate Hydrochloride for Injection Pivmecillinam Hydrochloride Saccharin Sodium Hydrate
Pivmecillinam Hydrochloride Tablets Salbutamol Sulfate Polymixin B Sulfate Sarpogrelate Hydrochloride Polyoxyl 40 Stearate
Sarpogrelate Hydrochloride Fine Granules Povidone
Sarpogrelate Hydrochloride Tablets
Prasterone Sodium Sulfate Hydrate Scopolamine Butylbromide Prazosin Hydrochloride
Scopolamine Hydrobromide Hydrate Prednisolone Acetate Freeze-dried Smallpox Vaccine Prednisolone Sodium Phosphate Sodium Acetate Hydrate Prednisolone Succinate Sodium Bisulfite
Prednisolone Sodium Succinate for Injection Sodium Carbonate Hydrate Procainamide Hydrochloride
Isotonic Sodium Chloride Solution
Procainamide Hydrochloride Injection Sodium Citrate Hydrate
Procainamide Hydrochloride Tablets Disodium Edetate Hydrate Procaine Hydrochloride
Dibasic Sodium Phosphate Hydrate
Procaine Hydrochloride Injection Sodium Picosulfate Hydrate Procarbazine Hydrochloride Sodium Starch Glycolate
Procaterol Hydrochloride Hydrate Dried Sodium Sulfite Prochlorperazine Maleate Sodium Thiosulfate Hydrate
Prochlorperazine Maleate Tablets Sorbitan Sesquioleate Promethazine Hydrochloride D-Sorbitol Propafenone Hydrochloride D-Sorbitol Solution
Propafenone Hydrochloride Tablets
Spectinomycin Hydrochloride Hydrate Propantheline Bromide Spiramycin Acetate Propiverine Hydrochloride Corn Starch
Propiverine Hydrochloride Tablets Potato Starch Propranolol Hydrochloride Rice Starch
Propranolol Hydrochloride Tablets Wheat Starch Protamine Sulfate Streptomycin Sulfate Protamine Sulfate Injection
Streptomycin Sulfate for Injection Protirelin Tartrate Hydrate Sucralfate Hydrate Pyridostigmine Bromide Sulfamethoxazole Pyridoxal Phosphate Hydrate Sulfamonomethoxine Hydrate Pyridoxine Hydrochloride Sulpyrine Hydrate
Pyridoxine Hydrochloride Injection Sultamicillin Tosilate Hydrate Quinapril Hydrochloride Sultamicillin Tosilate Tablets
Quinapril Hydrochloride Tablets Suxamethonium Chloride Hydrate Quinidine Sulfate Hydrate
Suxamethonium Chloride Injection Quinine Hydrochloride Hydrate
Suxamethonium Chloride for Injection Quinine Sulfate Hydrate Tacalcitol Hydrate Ranitidine Hydrochloride Talampicillin Hydrochloride 0.1z Reserpine Powder Taltirelin Hydrate Retinol Acetate Tamoxifen Citrate Retinol Palmitate Tamsulosin Hydrochloride xii Preface JP XVIII
Tamsulosin Hydrochloride Extended-release Tablets Vancomycin Hydrochloride Temocapril Hydrochloride
Vancomycin Hydrochloride for Injection
Temocapril Hydrochloride Tablets Verapamil Hydrochloride Terbinafine Hydrochloride
Verapamil Hydrochloride Tablets
Terbinafine Hydrochloride Cream Vinblastine Sulfate
Terbinafine Hydrochloride Solution
Vinblastine Sulfate for Injection
Terbinafine Hydrochloride Spray Vincristine Sulfate
Terbinafine Hydrochloride Tablets Zinc Sulfate Hydrate Terbutaline Sulfate Zolpidem Tartrate Testosterone Enanthate Zolpidem Tartrate Tablets
Testosterone Enanthate Injection 17.
The following monographs were deleted: Testosterone Propionate Cholera Vaccine
Testosterone Propionate Injection
Diphtheria-Tetanus Combined Toxoid Tetracaine Hydrochloride Gas Gangrene Antitoxin, Equine Tetracycline Hydrochloride Japanese Encephalitis Vaccine
Thiamine Chloride Hydrochloride
Freeze-dried Japanese Encephalitis Vaccine
Thiamine Chloride Hydrochloride Injection Methylrosanilinium Chloride
Thiamine Chloride Hydrochloride Powder
Live Oral Poliomyelitis Vaccine Thiamine Nitrate
Weil's Disease and Akiyami Combined Vaccine L-Threonine Tiapride Hydrochloride 18.
The following articles were newly added to Ul- Tiapride Hydrochloride Tablets
traviolet-visible Reference Spectra: Tiaramide Hydrochloride Bicalutamide
Tiaramide Hydrochloride Tablets Cabergoline Ticlopidine Hydrochloride Celecoxib Timepidium Bromide Hydrate Cloperastine Fendizoate Timolol Maleate Ethyl Loflazepate Tipepidine Hibenzate Fenofibrate Tipepidine Hibenzate Tablets Gefitinib Tizanidine Hydrochloride
Rilmazafone Hydrochloride Hydrate Tocopherol Rosuvastatin Calcium Tocopherol Acetate Triazolam Tocopherol Calcium Succinate Zopiclone Tocopherol Nicotinate 19.
The following articles were newly added to In-
Todralazine Hydrochloride Hydrate frared Reference Spectra: Tolnaftate Bicalutamide Tolnaftate Solution Cabergoline Tolperisone Hydrochloride Celecoxib Tosufloxacin Tosilate Hydrate Cloperastine Fendizoate Tosufloxacin Tosilate Tablets Copovidone Trehalose Hydrate Ethyl Loflazepate Trichomycin Fenofibrate Triclofos Sodium Gefitinib Triclofos Sodium Syrup
Rilmazafone Hydrochloride Hydrate Trihexyphenidyl Hydrochloride Rosuvastatin Calcium
Trihexyphenidyl Hydrochloride Tablets Sodium Lauryl Sulfate Trimebutine Maleate Triazolam Trimetazidine Hydrochloride Zopiclone
Trimetazidine Hydrochloride Tablets
Trimetoquinol Hydrochloride Hydrate
Those who were engaged in the preparation of JP 18 Tulobuterol Hydrochloride are as follows: L-Tyrosine ABE Misato Ursodeoxycholic Acid ABE Yasuhiro Ursodeoxycholic Acid Granules AITA Youhei Ursodeoxycholic Acid Tablets AKAO Kenichi
Valaciclovir Hydrochloride Tablets ARATO Teruyo JP XVIII Preface xiii ARIMOTO Keiko ITO Ryoichi ARUGA Naoki ITO Yuji ASAI Yumi IZUTANI Yusuke ASAMA Hiroshi IZUTSU Kenichi ASHIZAWA Kazuhide KAIDA Naoki ASO Shinichiro KAMMOTO Toshihiro ASO Yukio KANEBAKO Makoto DEMIZU Yosuke KATAYAMA Hirohito EMURA Makoto KATO Kumiko FUCHINO Hiroyuki KATORI Noriko FUJII Hirosato KAWAHARA Nobuo FUJII Makiko KAWAI Tamotsu FUJII Norikazu KAWAMATA Tomomi FUJIMOTO Yuzo KAWANISHI Toru FUKAMI Toshiro KAWANO Noriaki FUKASAWA Masayoshi KAWARASAKI Yoshihiko FUKAZAWA Hidesuke KAWASAKI Nana FUKUDA Shinji KIJIMA Keiji FUKUHARA Kiyoshi KIKUCHI Yutaka FURUICHI Harumi KIKUCHI Yuuichi FURUKAWA Hiromitsu KIMURA Noritaka GODA Yukihiro KISHIMOTO Yasuhiro GOTO Takashi KITADA Mitsukazu GOTO Tamami KITAJIMA Akihito HAISHIMA Yuji KITTAKA Atsushi HAKAMATA Hideki KIUCHI Fumiyuki HAKAMATSUKA Takashi KOBAYASHI Takashi HANADA Kentaro KOCHI Rika HANAJIRI Ruri KOHAMA Ai HARAZONO Akira KOHITA Hideki HASEGAWA Atsuhiro KOIDE Tatsuo HASHIDA Mitsuru* KOJIMA Takashi HASHII Noritaka KOKUBO Hiroyasu HATANO Rika KOMATSU Katsuko HAYAKAWA Masako KONDA Toshifumi HAYASHI Ai KONDO Seizo HAYASHI Akira KUBOSAKI Atsutaka HAYASHI Yoshinori KUBOTA Kiyoshi HIGANO Taro KUMASAKA Kenichi HIGUCHI Yasuhiko KURIHARA Masaaki HIRAI Kenichi KUROIWA Yuki HIYAMA Yukio KUSUNOKI Hideki HORI Masatoshi MAEKAWA Keiko HYUGA Masashi MAKIURA Toshinobu ICHINOSE Koji MARUYAMA Takuro IGOSHI Nobukazu MASADA Sayaka IIMORI Jumpei MATSUMOTO Kazuhiro IKARASHI Yoshiaki MATSUMOTO Makoto IKEDO Shingo MATSUMURA Hajime IKEGAMI Kazuhiko MATSUURA Tadashi IMAMOTO Tsuyoshi MIKAMI Eiichi INOUE Takayuki MISAWA Takashi ISHIDA Masato MITSUHASHI Takao ISHII Akiko MIYATA Naoki ITAI Shigeru MIYAZAKI Takashi ITO Michiho MIYAZAKI Tamaki xiv Preface JP XVIII MIZUNO Takeshi SATO Kyoko MORI Mitsuo SATO Norihisa MORIBE Kunikazu SEGAWA Masashi MORIMOTO Seiki SEKIGAWA Fujio MORIMOTO Takashi SEKIGUCHI Michiko MORISAKI Takahito SHIBATA Hiroko MORITA Osamu SHIBAYAMA Keigo MORIYASU Takako SHIBAZAKI Keiko MURABAYASHI Mika SHIDA Shizuka MURAI Toshimi SHIMADA Yasuo MUROI Masashi SHIMAZAWA Rumiko NAKA Nobuyuki SHIMIZU Masaro NAKAGAWA Hidehiko SHIMOKAWA Sayuri NAKAGAWA Shinsaku SHINOHARA Katsuaki NAKAGAWA Tsutomu SHIRATORI Makoto NAKAGAWA Yukari SHIROTA Osamu NAKAI Toru SHODA Takuji NAKAJIMA Emi SUDO Hirotaka NAKAKO Mayumi SUDO Keiichi NAKANO Tatsuya SUGAI Motoyuki NAKASHIMA Tatsumi SUGIMOTO Chishio NANAURA Mitsuo SUGIMOTO Naoki NASU Masao SUZUKI Mikio NISHIHARA Yutaka SUZUKI Noriyuki NISHIKAWA Noriaki SUZUKI Ryoji NISHIMURA Masahiro SUZUKI Shigeo NOGUCHI Shuji SUZUKI Tomoyuki OBA Sumiaki TACHIBANA Katsumi OBARA Sakae TADA Minoru OCHIAI Masaki TADAKI Shinichi OGAWA Toru TAGUCHI Nobuo OGURA Yasumitsu TAKAHASHI Yoshikazu OGURI Kazuki TAKAI Yoshiaki OHGAMI Yasutaka TAKANO Akihito OHTA Shigeru TAKAO Masaki OKUBO Tsuneo TAKEBAYASHI Kenji OKUDA Akihiro TAKEDA Osami OKUDA Haruhiro TAKEDA Tomoko OMURA Koichi TAKEUCHI Hirohumi ONO Makoto TAKEUCHI Hisashi ONODA Hiroshi TANABE Toyoshige OSUMI Yuko TANAKA Masakazu OTSUKA Masami TANAKA Satoshi OUCHI Tadashi TANAKA Setsuko SAITO Hideyuki TANAKA Tomohide SAITO Yoshiro TANIMOTO Tsuyoshi SAKAI Eiji TAOKA Yukako SAKAMOTO Tomoaki** TERABAYASHI Susumu SANTA Tomofumi TERADA Katsuhide SASAKI Hiroshi TERAOKA Reiko SASAKI Kunio TOKUMOTO Hiroko SASAKI Satoshi TOKUNAGA Hiroshi SASAKI Yuko TOKUOKA Shogo SASAOKI Kazumichi TOMIOKA Kiyoshi SATO Hiroyasu TOMITSUKA Hiroyuki SATO Koji TOYODA Taichi
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