Japanese Pharmacopoeia 18th edition

The Japanese Pharmacopoeia is the pharmaceutical standard that the Japanese Minister of Health, Labour and Welfare (MHLW) establishes to regulate the properties and quality of drugs.

The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria and standard test methods necessary to properly assure the quality of medicines in Japan. 

In July 2016, the Committee on JP established the basic principles for the preparation of the JP 18th Edition, setting out the roles and characteristics of the JP, the definite measures for the revision, and the date of the revision.
The JP 18th Edition carries 2033 articles, owing to the addition of 33 articles and the deletion of 8 articles.

1. The JP 18th Edition comprises the following items, in order: Notification of MHLW; Contents; Preface; General Notices; General Rules for Crude Drugs; General Rules for Preparations; General Tests, Processes and Apparatus; Official Monographs; then followed by Infrared Reference Spectra and Ultraviolet-visible Reference Spectra; General Information; Table of Standard Atomic Weights as an appendix; and a Cumulative Index.

2. The articles in Official Monographs, Infrared Reference Spectra and Ultraviolet-visible Reference Spectra are respectively placed in alphabetical order in Principle.

The following items in each monograph are put in the order shown below, except that unnecessary items are omitted depending on the nature of the drug: 
(1) English title
(2) Commonly used name(s)
(3) Latin title (only for crude drugs)
(4) Title in Japanese
(5) Structural formula or empirical formula
(6) Molecular formula and molecular mass
(7) Chemical name
(8) Chemical Abstracts Service (CAS) Registry Number
(9) Origin
(10) Limits of the content of the ingredient(s) and/or the unit of potency
(11) Labeling requirements
(12) Method of preparation
(13) Manufacture
(14) Description
(15) Identification tests
(16) Specific physical and/or chemical values
(17) Purity tests
(18) Potential adulteration
(19) Loss on drying or Ignition, or Water
(20) Residue on ignition, Total ash or Acid-insoluble ash
(21) Tests being required for pharmaceutical preparations
(22) Other special tests
(23) Assay
(24) Containers and storage
(25) Shelf life
(26) Others

In each monograph, the following physical and chemical values representing the properties and quality of the drug are given in the order indicated below, except that unnecessary items are omitted depending on the nature of drug:
(1) Alcohol number
(2) Absorbance
(3) Congealing point
(4) Refractive index
(5) Osmolar ratio
(6) Optical rotation
(7) Constituent amino acids
(8) Viscosity
(9) pH
(10) Content ratio of the active ingredients
(11) Specific gravity
(12) Boiling point
(13) Melting point
(14) Acid value
(15) Saponification value
(16) Ester value
(17) Hydroxyl value
(18) Iodine value

Identification tests comprise the following items, which are generally put in the order given below:
(1) Coloration reactions
(2) Precipitation reactions
(3) Decomposition reactions
(4) Derivatives
(5) Infrared and/or ultraviolet-visible absorption
(6) Nuclear magnetic resonance spectrometry
(7) Chromatography
(8) Special reactions
(9) Cations
(10) Anions
Purity tests comprise the following items, which are generally put in the order given below, except that unnecessary items are omitted depending on the nature of drug:
(1) Color
(2) Odor
(3) Clarity and/or color of solution
(4) Acidity or alkalinity
(5) Acidity
(6) Alkalinity
(7) Chloride
(8) Sulfate
(9) Sulfite
(10) Nitrate
(11) Nitrite
(12) Carbonate
(13) Bromide
(14) Iodide
(15) Soluble halide
(16) Thiocyanate
(17) Selenium
(18) Cationic salts
(19) Ammonium
(20) Heavy metals
(21) Iron
(22) Manganese
(23) Chromium
(24) Bismuth
(25) Tin
(26) Aluminum
(27) Zinc
(28) Cadmium
(29) Mercury
(30) Copper
(31) Lead
(32) Silver
(33) Alkaline earth metals
(34) Arsenic
(35) Free phosphoric acid
(36) Foreign matters
(37) Related substances
(38) Isomer
(39) Enantiomer
(40) Diastereomer
(41) Polymer
(42) Residual solvent
(43) Other impurities
(44) Residue on evaporation
(45) Readily carbonizable substances

The following paragraph was newly added to General Notices:

(1) Paragraph 34: The provision for elemental impurities based on ICH Q3D ``Guideline for Elemental Impurities'' was added.
The following paragraph of General Notices was revised: 
Paragraph 8: Atomic masses adopted in the Japanese Pharmacopoeia were determined to conform to the table of ``Atomic  
Weights of the Elements 2015'' (IUPAC), however, the atomic masses of the elements whose atomic weight is indicated with an interval in the 2015 table were determined to conform to the table of ``Atomic Weights of the Elements 2007'' (IUPAC). 
The following item was newly added to General Tests, Processes and Apparatus: (1) 2.05 Size-Exclusion Chromatography

The following items in General Tests, Processes and Apparatus were revised:
(1) Preamble
(2) 2.46 Residual Solvents
(3) 2.48 Water Determination
(4) 2.51 Conductivity Measurement
(5) 2.52 Thermal Analysis
(6) 2.66 Elemental Impurities
(7) 4.06 Sterility Test
(8) 5.01 Crude Drugs Test
(9) 9.01 Reference Standards
(10) 9.41 Reagents, Test Solutions
(11) 9.62 Measuring Instruments, Appliances

The following Reference Standards were added:
Bicalutamide RS
Cabergoline RS
Celecoxib RS
Eribulin Mesilate RS
Eribulin Mesilate Related Substance C for System
Suitability RS
Ethyl Loflazepate RS
Fenofibrate RS
Gefitinib RS
Glucagon RS
Rilmazafone Hydrochloride RS
Rosuvastatin Calcium RS
Saccharin RS
Timolol Maleate RS
Triazolam RS

The following Reference Standard was revised in Japanese title:
Saccharin Sodium RS







Post a Comment


Table of Contents