JP 17th Edition of Japanese Pharmacopoeia can download free in a pdf file here. Japanese Pharmacopoeia (JP) is used in Japan to ensure the standard of medicine. The English translation of the 17th edition of Japanese Pharmaceuticals (JP XVII) has been fully approved by the Society of Japanese Pharmacopoeia. It describes the specifications, standards and standard testing methods required to ensure the correct quality of medicines in Japan. The Japanese language edition was effective April 1, 2016. Pharmacopoeia is a series in British is known as British Pharmacopoeia similarly in the USA has its own USP Pharmacopoeia.
( United States Pharmacopeia 2020 here)
Features of JP 17th
Followings are the key features of Japanese Pharmacopoeia JP 17th Edition (JP-17)
- General tests, processes and apparatus: 23 new standards and 10 revised standards.
- Infrared reference spectra: 21 new spectra and 2 revised spectra.
- Ultraviolet-visible reference spectra: 14 new spectra and 2 revised spectra.
- General Notices, General Rules for Crude Drugs, General Rules for Preparations: revised and expanded.
- Official monographs: 76 new monographs and 473 revised monographs.
Moto of JP Series:
The main purpose of Japanese Pharmacopoeia is to ensure the quality of drug in Japan such as
1. Include all medications that are important from a healthcare and medical treatment perspective.
2. Improve quality by introducing the latest science and technology.
3. Promote internationalization.
4. Perform quick partial revisions as needed and simplify smooth administrative work.
5. Ensure transparency in the review process, and make the JP public.
That’s why Japanese Pharmacopoeia has updated the JP 17th edition in pdf
The Japanese Pharmacopoeia (JP) is an official document that describes the specifications, standards, and standardized testing methods required to ensure the quality of medicines in Japan.
Paragraph 2, Article 41 of the law stipulates that the quality, efficacy and safety products, including pharmaceuticals and medical devices, must be subject to a full JP review at least every 10 years. Since the 9th edition of JP, a complete review has been done every 5 years. In addition to the full revisions, a supplement has been issued twice every 5 years since the 12th edition of the JP, and a partial revision has been required in view of recent advances in science and the interests of international coherence. The 16th edition of the JP was issued on March 24, 2011, through Ministry Notification No. 65 of the Ministry of Health, Labor and Welfare (MHLW).
In July 2011, the Committee on JP laid down the basic principles for the preparation of the 17th edition of the JP set out the role and characteristics of the JP, definitive steps for revision and the date of revision.
In the committee, the five basic principles of JP,
- including all the medicines that are important from the point of view of health care and medical treatment.
- Improving quality by introducing modern science and technology
- Promoting internationalization
- Necessary partial revision to facilitate smooth and smooth administrative work, and
- Ensuring transparency regarding revision Making, and delivering JP to the people. It was agreed that the Committee on JP should work on the basis of these principles to ensure that JP is properly utilized in the areas of healthcare and medical treatment, including Receiving the understanding and cooperation of others.
Origin of JP in Japan
It was agreed that JP should provide a government standard, which is necessary to ensure the quality of medicines in Japan at present in the development of science and technology and in response to medical requirements. It should specify the standards of specifications as well as the testing methods to ensure the overall quality of all drugs in principle and should have a role in clarifying the quality of drug assurance that is Considered essential for public health. And medical treatment. JP has been developed with the knowledge and experience of many professionals in the field of pharmaceuticals. Therefore, the JP should have the characteristics of a government standard, which can be widely used by all parties concerned, and it should play an appropriate role in providing information and understanding to the public about the quality of medicines. Furthermore, as a benchmark for pharmaceutical standards, it must play its part in promoting and maintaining the technical requirements in the international community, as well as international consistency and coherence. It was also agreed that JP articles should cover medicines as soon as possible after reaching the market in terms of health care and medical treatment, medical performance or merits and frequency of use. The target date for the publication of JP 17th Edition (Japanese Edition) was set for April 2016.
Content of JP Seventeenth Edition
The official monograph section of the Japanese Pharmacopoeia contains about 17,764 articles, including 106 new additions, 15 updated and 330 revised articles.
The main features and revisions of this book are:
- A full revision of General Rules for Preparations, including the classification of dosage forms by administration route and application site.
- The addition of 43 monographs for preparations, and the change of the definitions
Revision of General Notices, Official Monographs and General Information on pharmaceutical water.
The following tests, processes and tools have been reviewed.
- 2.01 Liquid Chromatography
- 2.46 Residual Solvents Test
- 2.51 Conductivity Measurement
- 2.54 pH Determination
- 2.58 X-Ray Powder Diffraction Method
- 3.01 Determination of Bulk and Tapped Densities
- 4.01 Bacterial Endotoxins Test
- 4.05 Microbial Limit Test
- 4.06 Sterility Test
- 5.02 Microbial Limit Test for Crude Drugs
- 6.03 Particle Size Distribution Test for Preparations
- 6.07 Insoluble Particulate Matter Test for Injections
- 6.08 Insoluble Particulate Matter Test for Ophthalmic Solutions
- 7.02 Test Methods for Plastic Containers
- 8.01 Sterilization and Aseptic Manipulation credit: Amazon
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