Pharmacopeias Japanese Pharmacopoeia

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... 

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

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. 

Note BP, British Pharmacopoeia JP, Japanese Pharmacopoeia PhEur, European Pharmacopoeia USPNF, U.S. Pharmacopeia/National Formulary. All are USPNF specifications, except as indicated below. 

The regulatory authority in Mexico is the Direccion General de Control de Insumos para la Salud (DIGE-CIS). The Health Secretariat issues pharmaceutical registration. Safety and efficacy must be proven by phase III clinical trials in Mexico to register drugs that are new to the Mexican market. All major pharmacopeia (/ntemahona/ Pharmacopoeia, US Pharmacopeia, British Pharmacopoeia, French Pharmacopoeia, Swiss Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia) are acceptable in Mexico. 

The pharmacopeial standard applying to sterile products is that they must be capable of passing a Test for Sterility. A Test for Sterility is described in U.S. Pharmacopeia (USP) under Section 71 and in the European Pharmacopoeia (PhEur) under Section 2.6.1. These were harmonized along with the Japanese Pharmacopoeia and the requirements of the Australian Therapeutic Goods Administration in 1999, but they still have some minor differences in detail. 

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. 

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. 

Methods of Analysis and Excipient Monographs, in 1989 the Ph Eur. the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP) formed a Pharmacopoeial Discussion Group (PDG) (for details of the PDG process see Table 16.3). However, progress is slow. At the time of... 

Stage 3 Publication of the draft text in the forum of each pharmacopoeia Pharmeuropa (Ph Eur), Japanese Pharmacopoeial Forum (Japanese Pharmacopoeia) and Pharmacopeial Forum (United States Pharmacopeia) Comments received and consolidated Preparation of a second draft text ( Stage 4 draft )... 

The full utility of this Guideline is dependent on the successful completion of harmonization of pharmacopoeial procedures for several attributes commonly considered in the specification for new drug substances or new drug products. The Pharmacopoeial Discussion Group of the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia has expressed a commitment to achieving harmonization of the procedures in a timely fashion. 

There are various pharmacopoeias worldwide, which, among other things, define the quality attributes of drug substances and, in some cases, drug products (see Uhapter 9). Some of the most well known ones include the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP). ... 

The United States Pharmacopeia/European Pharma-copoeia/Japanese Pharmacopoeia (USP/EP/JP) rotating paddle apparatus (Figure 1) is recommended for... 

Nihon Yakukyokuho Kaisetusho Henshu Iinkai (Editorial Board of the Manual of Japanese Pharmacopoeia) Dai 13-Kaisei Nihon Yatkyokuho Kaisetusho (Manual of Japanese Pharmacopeia 13th edn.), p. D-227, Tokyo Hirokawa, 1996. 

After several years of negotiation the sterility tests of the European Pharmacopoeia, The United States Pharmacopeia and the Japanese Pharmacopoeia are harmonised [59]. In the next sections the five steps of this harmonised test, as described in Ph. Eur. 2.6.1 will be discussed sampling, sample preparation, inoculation, incubation, and interpretation. Prior to the routine application of the test, a suitability test with a range of specified test organisms shall demonstrate that growth of these organisms is not inhibited due to residual antimicrobial activity of the product. 

Most of the pharmaceutical polymers used in ASD have already been approved for oral applications by major regulatory agencies (e.g., FDA, EMA) and have been published in the pharmacopeias (USP European Pharmacopoeia, Ph. Eur. Japanese Pharmacopoeia, JP). When evaluating safety of excipients used in solid dispersions, several factors have to be considered such as maximum allowable limit (IID) and LD50 (Table 4.7). 

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. 

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... 

The three regional pharmacopeias—the USP, the European Pharmacopoeia (EP), and the Japanese... 

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. 

Copovidone fulfills the requirements of the Copovidone and Copolyvidone monographs in the current versions of the European Pharmacopeia (Ph.Eur. 5) and Japanese Pharmaceutical Excipients (JPE 1993). It also corresponds to the USP-NF draft monograph Copovidone published 2002 [652]. The current phar-macopoeial specifications are listed in Table 153. Several of the parameters are not included in the monographs but are general requirements of the pharmacopoeias. 

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