Japanese Pharmacopoeia

The Pharmacopoeia of Japan, The Society of Japanese Pharmacopoeia, Tokyo, Japan, 1987. 

Japanese Pharmacopoeia, 14th edn., Society of Japanese Pharmacopoeia, Japan, 2001, p. 665. 

Sinkers are used for floating or sticking of dosage forms. The description of sinkers in <711> is brief and not detailed. An example of a hand-made USP sinker is shown in Figure 6. In Figure 7, the sinker described in the Japanese Pharmacopoeia (JP) is pictured, but several other sinkers are available commercially. Since <711> contains the statement that other validated sinkers may be used, any of these designs could be considered. 

Compendial Requirements of Dissolution Testing—European Pharmacopoeia, Japanese Pharmacopoeia, United States... 

In the intervening years, the increase in specifications for oral dosage forms dissolution has been less dramatic. The 14th edition of the Japanese Pharmacopoeia (2002) has included additional dissolution tests for tablets and capsules. Out of a total of 61 tablet monographs, dissolution tests are included in 32. From four capsule monographs, one dissolution test is given (19). 

Uchiyama M. Pharmacopeial standards Japanese Pharmacopoeia. In Swarbrick J, Boylan JC, eds. Encyclopedia of Pharmaceutical Technology. Vol. 12. New York Marcel Dekker, 1995 73-79. 

JP. The Japanese Pharmacopoeia. 14th ed. English Version. Tokyo Society of Japanese Pharmacopoeia, 2001. 

Organization (WHO) (16), European Pharmacopoeia (PhEur) (14), Japanese Pharmacopoeia (JP) (15) product 0.05 units of the prescribed valued product... 

Currently, the Japanese Pharmacopoeia (JP) is the only pharmacopeia that requires a specific sinker device for all capsule formulations. The USP recommends a few turns of a nonreac-tive material wire when the dosage form tends to float (12) (see Chapter 2 for illustrations of the Japanese and USP sinkers). Because sinkers can significantly influence the dissolution... 

The Japanese Pharmacopoeia 14th Edition 2001. General Test 15. Dissolution Test Society of Japanese Pharmacopoeia Japan, 2001 33-36. 

The Japanese pharmacopoeia has not yet included a general method description of CE. Ceneral chapter 8 in the Japanese Pharmacopoeia 15. 

TABLE 3 Equations used in European Pharmacopoeia Chapter 2.2.47, Japanese Pharmacopoeia Chapter 8, ° and United States Pharmacopeia Chapters <727> and ... 

Japanese Pharmacopoeia, 15th edition. (2006). General Information, chapter 8, Capillary Electrophoresis. 

Society for the Japanese Pharmacopoeia, Japan Pharmaeopeial Forum, l(l) 20-29 (1992). Pharmaeopeial Forum, 19(4) 5849 (1993). 

Japanese Pharmacopoeia, 14th ed., Chapter 15, Dissolution Test, pp. 33-36, 2001. 

In this chapter we describe characteristic validation procedures of the Heavy Metals Limit Test in the Japanese Pharmacopoeia (JP) [1]. Although an equivalent test is commonly listed in both the United States Pharmacopoeia and the European Pharmacopoeia, there are differences in the color reagents and conditions of sample preparation of the JP procedure. Heavy metals are defined in the JP as poisonous metallic impurities such as Pb, Bi, Cu, Cd, Sn, and Hg that form colored colloidal precipitates with sodium sulfide TS in a slightly acidic solution of pH 3 to 4. The level is expressed as the equivalent quantity of lead. 

Japanese Pharmacopoeia, JP XIV, General Tests, Processes and Apparatus, 26, Heavy Metals Limit Test, p. 43. See http //jpdb.nihs.go.jp/jpl4e/contents.html. 

Spreadsheets that can be used for multiple purposes or that can generate multiple types of information are sometimes preferred over single-purpose spreadsheets. An example is a spreadsheet designed to work for different products or a spreadsheet designed to produce multiple result sets from a single data set [e.g., a content uniformity evaluation according to European Pharmacopoeia (Pharm. Eur.), United States Pharmacopoeia (USP), and Japanese Pharmacopoeia (JP) (prior to ICH harmonization)]. 

The corresponding secretariats may have to add information essential to the understanding of the implementation of the texts (e.g., the description of an analytical procedure or of reagents that do not exist in the pharmacopeia) and a translation is added by the European and Japanese Pharmacopoeias. The style may be adapted to that of the pharmacopeia concerned or global style may be used. A pharmacopeia can add text, either to amplify some of the requirements with additional information or because national requirements and compendial policy dictate that the addition is necessary. However, there must be a clear indication that this additional information is not part of the harmonized document. This will avoid additional text being included after the harmonization process is completed, but will allow interested parties to review a complete text. The three pharmacopeias endeavor to publish the drafts simultaneously or as close together as possible. 

A compendial excipient should comply with the current revision of the official compendium cited. Therefore, when citing an official compendium, the version of the compendium should not be included in the citation. For example, the NF should be cited rather than NF 20. Certain General Chapters in the USP contain a statement that the text of the USP is harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia. However, where a difference appears, or in the event of a dispute, the result obtained from the USP procedure is conclusive. 

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