Japanese Pharmacopeia

Citric acid specifications are defined in a number of compendia including Vood Chemicals Codex (FCC), United States Pharmacopeia (USP), British Pharmacopeia (BP), European Pharmacopeia (EP), and Japanese Pharmacopeia (fP). 

Water for injection (WFI) is the most widely used solvent for parenteral preparations. The USP requirements for WFI and purified water have been recently updated to replace the traditional wet and colorimetric analytical methods with the more modern and cost-effective methods of conductivity and total organic carbon. Water for injection must be prepared and stored in a manner to ensure purity and freedom from pyrogens. The most common means of obtaining WFI is by the distillation of deionized water. This is the only method of preparation permitted by the European Pharmacopoeia (EP). In contrast, the USP and the Japanese Pharmacopeias also permit reverse osmosis to be used. The USP has also recently broadened its definition of source water to include not only the U.S. Environmental Protection Agency National Primary Drinking Water Standards, but also comparable regulations of the European Union or Japan. 

Figure 7 The sinker required in the Japanese Pharmacopeia. (Courtesy of VanKel, a member of the Varian, Inc. Life Science Business, Cary, North Carolina, U.S.A.)...

Currently the U.S., European, and British pharmacopeias specify different requirements for delivered dose uniformity. Table 5 describes these requirements as well as proposed FDA expectations [33]. The Japanese pharmacopeia does not speeify a delivered dose uniformity requirement. Current compendia should be eonsulted as referenees. 

United States, European, and Japanese pharmacopeia have described general requirements, specifications, and tests for monitoring microbial bioburden in nonsterile pharmaceutical products. Although there are minor differences in the expectations of the pharmacopeia, the general principles for microbial bioburden monitoring remain similar as described below. 

Abbreviations. JP, Japanese Pharmacopeia NF, National Formulary BP, British Pharmacopeia USP, Unitied States Pharmacopeia Ph Eur, European Pharmacopeia. 

Abbreviations. PhEur, European Pharmacopeia J Ph, Japanese Pharmacopeia. 

Water for injection. Japanese Pharmacopeia. 14th ed. Tokyo Hirokawa, p. D-751... 

Control of excipients is often built around the various pharmacopeial standards including the British Pharmacopoeia (BP), European Pharmacopoeia (PhEur), Japanese Pharmacopeia (JP) and the United States Pharmacopeia/National Formulary (USP/NF). The use of excipients that conform to a compendium ensures that the material meets the established specifications and acceptance criteria. This provides a handle on the batch-to-batch variability of the excipients used, as well as an option to select from multiple vendors for controlling the cost of goods. However, the pharmaceutical industry has long recognized that these standards are... 

SMV, sample mean value RSD, relative standard deviation w, number of replicates USP, United State Pharmacopeia IP, Japanese Pharmacopeia EP, European Pharmacopeia. 

There is a Japanese pharmacopeia that sets official standards and diverse government agencies that perform tasks undertaken by an FDA. It is rumored that... 

The establishment of reference standards is adopted at the suggestion of the related panels after due consideration of the opinion of the NIHS, which is directly responsible for establishing those reference standards in cooperation with the Society of Japanese Pharmacopoeia. The Society of Japanese Pharmacopeia (Shibuya 2-12-19, Shibuya, Tokyo 150-0002, Japan) is a non-profit private organization that carries out activities in support of MHW administration and regulation of pharmaceuticals. The Society plays several roles and, in particular, makes reference standards available including a part of the pharmacopeial reference standards. It also distributes Pharmacopeia and related informative documents, such as the JP Forum, and convenes public meetings and symposia. 

After finalization by each panel, all drafts for revision are opened for public comment through the JP Forum, a vehicle for notification and commentary. The JP Forum is published quarterly by the Society of Japanese Pharmacopeia under the auspices of the JP secretariat. The JP Forum was first published in January 1992 as a medium for both local and international communication. It will continue to provide a more open revision process for the JP and announce revisions and future directions of the JP committees. The JP Forum is issued in Japanese, primarily for domestic users, but articles related to the international community and commentary will be issued in English concurrently with the Japanese version. Therefore, we anticipate that the JP Forum will aid in the process of international harmonization and will promote a better understanding of and increased trust in the JP. 

After comments are reviewed and changes are made, the revised draft is reviewed by the Committee on the Japanese Pharmacopeia and then by the Executive Committee of the Central Pharmaceutical Affairs Council before it is submitted for publication in the JP. 

In the licensing process, it is essential for each regulatory authority to recognize as equivalent those test procedures that have been harmonized and adopted as validated methods by the PDG. This concept is already included in the Japanese Guidelines for Preparation of Section B of the Documents Accompanying New Drug Applications as of September 1995 in its assertion that, The analytical procedures in the Japanese Pharmacopeia and other compendia and those which are accepted through international harmonization are considered to be validated methods. ... 

Society of Japanese pharmacopeia. In The Japanese Pharmacopeia, 13th Ed. Yakuji Nippo, Ltd. Tokyo, 1996 http // WWW. y akuj i. CO. jp. 

Society of Japanese pharmacopeia. In Japanese Pharmacopeial Forum Society of Japanese Pharmacopeia Tokyo, http //www.sjp.or.jp. 

Efforts are under way to make the USP-NF more useful worldwide. Incorporation of monographs for multi-vitamin products, biotechnology-derived products, veterinary drugs, and botanicals and other dietary supplements help. The US AN and USP Dictionary of Drug Names has wide international applicability, thereby making it a repository of International Names Nomenclature (INN) and British Adopted Names (BAN), as well as U.S. Adopted Names (USAN). Pharmacopeial Forum now contains announcements of proposals from the Japanese Pharmacopeia and European Pharmacopeia for revision of standards for international harmonization. 

ICH). It was drafted by the Japanese Pharmacopeia and agreed on by the European Pharmacopeia and the USP. In adopting the harmonized BET, the USP chapter introduced radical changes. The text was simplified to make it easier to understand and follow. Whereas the previous version was a gel-clot test only, the new BET provides standardization for both gel-clot and photometric LAL methods. Any validated method may be used for a USP article however, the gel-clot method is the referee test in the unlikely case of a dispute. 

Pharmacopeial Standards European Pharmacopeia / 2829 Pharmacopeial Standards Japanese Pharmacopeia / 2836 Pharmacopeial Standards United States Pharmacopeia and Nationai... 

Mitsuru Uchiyama / Society of Japanese Pharmacopeia, Tokyo, Japan Merlin L. Utter / Wyeth Research, Pearl River, New York, U.S.A. 

Section 1, Nonproprietary Names, lists the excipient names used in the current British Pharmacopoeia, European Pharmacopeia, Japanese Pharmacopeia, and the United States Phar-macopeia/National Formulary. 

Section 9, Pharmacopeial Specifications, briefly presents the compendial standards for the excipient. Information included is obtained from the British Pharmacopoeia (BP), European Pharmacopeia (PhEur), Japanese Pharmacopeia (JP), and the United States Pharmacopeia/National Formulary (USP/ USPNF). Information from the JP, USP and USPNF are included if the substance is in those compendia. Information from the PhEur is also included. If the excipient is not in the PhEur but is included in the BE, information is included from the BP. Pharmacopeias are continually updated with most now being produced as annual editions. However, although efforts were made to include up-to-date information at the time of publication of this edition, the reader is advised to consult the most current pharmacopeias or supplements. 

Japanese Pharmacopeia, 14th edn. and supplement. Tokyo Yakuji Nippo, 2001. 

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