The Japanese Pharmacopoeia (JP) is a comprehensive reference book that contains official standards for the quality, safety, and efficacy of drugs and medical devices used in Japan. The 14th edition of the JP was published in 2021 and it is the most recent version of this important reference.
The JP 14th edition contains standards for over 4,700 drugs and medical devices, including traditional Japanese medicines, herbal medicines, and synthetic drugs. It is an essential resource for manufacturers, regulators, and healthcare professionals who need to ensure that the products they produce, approve, or prescribe meet the high standards required for use in Japan.
The JP 14th edition is organized into four volumes, with each volume covering a different aspect of the standards for drugs and medical devices. The first volume covers general information and requirements for drugs and medical devices, including quality control and packaging requirements. The second volume covers standards for drugs, including chemical and physical properties, identification tests, and purity tests. The third volume covers standards for traditional Japanese medicines, including herbal medicines and crude drugs. The fourth volume covers standards for medical devices, including materials, performance, and safety requirements.
The JP 14th edition also includes new and updated standards, including revised standards for impurities in drug substances, new standards for traditional Japanese medicines, and updated requirements for medical device labeling and instructions for use.
The JP 14th edition is published by the Ministry of Health, Labor, and Welfare in Japan, and it is recognized as the official pharmacopeia for drugs and medical devices in Japan. It is also used as a reference by other countries in Asia and around the world, making it an important international standard for drug and medical device quality and safety.
In conclusion, the Japanese Pharmacopoeia 14th edition is an essential resource for anyone involved in the production, regulation, or use of drugs and medical devices in Japan. Its comprehensive standards and updated requirements ensure that products meet the high standards required for use in Japan and are recognized internationally.
This is the English version of the 14th edition of the "Japanese Pharmacopoeia". It provides the official Japanese standard for the description and quality of drug substances and products. It contains over 1,300 articles regarding: general rules for preparations; processes and apparatus; monographs on drugs; and infrared reference spectra and ultraviolet-visible reference spectra.
"synopsis" may belong to another edition of this title.
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