British pharmacopeia

Benzaldehyde is sold as technical grade or as meeting the specifications of the NationalVormulary (NF) (7), the Vood Chemicals Codex (FCC) (8), or the British Pharmacopeia (BP) (9) (Tables 4 and 5). The test methods used for the analysis of benzaldehyde are standard methods, with the exception of the assay method. 

Table 5. British Pharmacopeia and Technical Grade Specifications ...

British Pharmacopeia, Her Majesty s Stationery Office, London, 1988, pp. 62—63. 

Benzoic acid is available in industrial and technical grades, and in grades meeting the specifications of the United States Pharmacopeia (18), the Pood Chemicals Codex (19), or the British Pharmacopeia (20). Typical specifications are Hsted in Table 5. Analytical methods required for testing to meet the specifications listed in regulatory texts are described in those texts. 

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). 

The contribution of Rubiaceae to Western pharmaceuticals and medicine is substantial because it is the source for Uncaria gambier (Hunt.) Roxb. (Catechu, British Pharmaceutical Codex, 1963), Cephaelis ipecacuanha (Brot.) A. Rich. (uragoga ipecacuanha, Brazilian ipecacuanha), or Cephaelis acuminata Karsten (Cartagena ipecacuanha) (Ipecacuanha, British Pharmacopeia, 1963), Cinchona calisaya (yellow... 

In contrast to aspirin itself, the U.S.P. monograph for aspirin tablets has undergone considerable changes. For some reason, U.S.P. does not use the ferric salt test for free salicylic acid, as does the British Pharmacopeia of 1973. Apparently, certain excipients such as citric and tartaric acid interfere with this reaction.77 Already in 1913, a double titration method was developed78 which was made an official method in 1926.79 This method was used as the assay method when the aspirin tablets monograph was introduced into U.S.P. XII in 1942. 

British Pharmacopeia Commission (1973) British Pharmacopeia. London, HMSO, p. 221. 

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. 

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

Abbreviations. PEG, polyethylene glycol NF, National formulary BP, British Pharmacopeia. 

Uses.—Opoponax was formerly employod in medicine, hut it is now banished from the Materia Medica as enumerated in the British Pharmacopeias, It is adapted to the same eases as the other gum-resins of this doss. Dr. PEretra is of opinion, that it is more allied to ammoniacurn than to any other of these substances. 

Several officially recognized compendia describe specifications for components and finished product (e.g., U.S. Pharmacopeia, Food Chemicals Codex, British Pharmacopeia, and European Pharmacopeia). These specifications have been established by an advisory board to each compendium and represent the views of many manufacturers and government based on a history of the component or product. Such specifications are reviewed and updated as the need arises when new information becomes available. These compendia are very useful and should always be used as a guide whenever possible. In the case of the USP, for example, if a monograph exists for a component or product, U.S. drug manufacturers are required to satisfy those specifications as a minimum requirement. 

The British Pharmacopeia", Her Majesty s Stationary Office, Cambridge (1980). 

Reference material is obtainable from both the U.S. Pharmacopeia and the British Pharmacopeia (13-14). 

Assessment of indomethacin powder had been specified in the U.J5. XIX and the British Pharmacopeia, 1980 as a back titration with hydrochloric acid after alkaline hydrolysis(13,14). This method can attain a precision of + 0.8%(62). A direct titration for tablets and capsules is described using sodium hydroxide. If performed rapidly with phenolphthalein indicator, a precision of +0.3% is attainable. 8 The latter procedure serves to differentiate ester formation as well as hydrolysis products from intact material. The presence of parachlorobenzoic acid and 5-methoxy-2-methylindole-3-acetic acid are cause for positive error. 

The USP XX monograph requires the specific rotation to be between -30° and -36°, calculated on the dried basis and determined at 7 mg/ml in methanol solution [25], In the British Pharmacopeia the levorotatory optical activity is used as an identification test [27]. 

Pharmaceutical or Practical. These chemicals meet the specifications of the U.S. Pharmacopeia (USP) or the National Formulary (NF). USP/NF quality chemicals are approximately 97% pure and can be used for almost all photographic work. In Great Britain, they are labeled either BP (British Pharmacopeia) or BPC (British Pharmaceutical Codex). 

Although the British Pharmacopeia (BP) directs that proguanil hydrochloride should be protected from light, studies suggest that it is a very stable compound with only small amounts of its major decomposition product (4-chloroaniline) formed during thermal and photochemical stress.188... 

Of the four pharmacopoeias, the U.S. Pharmacopeia (USP) has the strictest requirements for delivered-dose uniformity. Although the British Pharmacopeia (BP) allows the same performance range, the USP defines the range around the label claim, and the BP defines the range around the average value. FDA expectations for delivered-dose uniformity is currently tighter than those specified in all the pharmacopeias. 

This distinction was expressed well by the late C.A. Johnson of the British Pharmacopeia ... 

Both are legal instruments, both are recognized in the laws of countries other than those of origin, both establish standards for dosage forms as well as for bulk pharmaceutical chemicals. Both use experts from industry, academia, and government at all stages of standards development. Also, for most of its history, the British Pharmacopeia was not a direct government effort. 

There are national pharmacopeias established by governments to meet perceived needs for compendial standards for locally produced articles. A number of these have published recent editions as evidence of continuing commitment, but it is often difficult to locate a U.S. bookseller for these. Cities of publication are Berlin, Paris, Prague, Rome, Tokyo, Peking, Seoul, Stuttgart, and Taipei. Most countries require imported articles to conform to one or another widely recognized pharmacopeia, such as the USP or the British Pharmacopeia. 

Many similarities existed between the British Pharmacopeia and the USP. Common elements of origin, continuing commerce, and a long history of cooperation have resulted in close correspondence in critical details. 

Dry-heat sterilization is generally a less complicated process than steam sterilization it is, however, relatively slow and requires higher temperatures and/or longer exposure times. This is because of the fact that microbial lethality is lower with dry heat than that for steam at the same temperature. There are various temperatures and periods of treatment for dry heat depending on the pharmacopeia. The U.S. Pharmacopeia (USP) states that the dry-heat sterilization process for containers for sterile pharmaceutical products should be at a temperature of 160-170°C for a period of 2-4 hr. The British Pharmacopeia states that items sterilized by dry heat should be kept at a temperature not less than 160°C for at least 1 hr. For the Pharmacopeia Nordica, the recommendation is 30 min at 180°C. Different materials and sterilization equipment used account for the discrepancies between these pharmacopeias, but there is also a lack of sufficient information concerning dry-heat sterilization. ... 

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