United States Pharmacopeia Standards

Quality Control. Because fine chemicals are sold according to specifications, adherence to constant and strict specifications, at risk because of the batchwise production and the use of the same equipment for different products ia multipurpose plants, is a necessity for fine chemical companies. For the majority of the fine chemicals, the degree of attention devoted to quahty control (qv) is not at the discretion of the iadividual company. This is particularly the case for fine chemicals used as active iagredients ia dmgs and foodstuffs (see Fine chemicals, standards). Standards for dmgs are pubHshed ia the United States Pharmacopeia (USP) ia the United States (6) and the European Pharmacopeia ia Europe (7). 

United States Pharmacopeia. Reference standards are requited in many USP and NF tests, and in a few FCC tests. The USPC distributes such standards domestically and has authorized international distribution by a number of organizations or companies. There are well over 1000 USP Reference Standards, including several for melting points, and also specimens of narcotics and other controlled substances. New standards are constantly under development as needed in various USP, NF, and FCC testing methods. 

Specifications and standards for various vitamin E forms and preparations for use in pharmaceutical appHcations ate given in the United States Pharmacopeia (52). AH products should contain not less than 96.0% or more than 102.0% of the appropriate form. The products must be labeled to indicate both the chemical and stereochemical forms contained in the product. 

Both recycled and non-recycled essential oils met the standards for specific gravity, angular rotation and refractive index of the Food Chemicals Codex [22] and United States Pharmacopeia [23] for cold-pressed lemon peel oil. Results of gas chromatography analysis show the same compounds and levels in both systems, specially for the oxygenated compounds as citral (neral and geranial). Therefore, recycling the aqueous discharges to the extractor does not cause undesirable modifications. 

USPC, The United States Pharmacopeia is a compendium of information on drug products. The standards set forth in the USP are recognized in both federal and state law. 

A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (If the method employed is in the current revision of the United States Pharmacopeia, National Formulary, Association of Official Analytical Chemists, Book of Methods, or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall be verified under actual conditions of use. 

Trade associations and the compendia also played an important role in drug product control and quality during the nineteenth and twentieth centuries. The United States Pharmacopeia (USP) and National Formulary (NF) established standards of potency and... 

The United States Pharmacopeia (USP) (or other national or regional pharmacopeia) provides standards for a large number of drug substances and drug products. Some of these standards are particularly relevant to bioequivalency. First, USP products are... 

All bioassays are comparative in nature, requiring parallel assay of a standard preparation against which the sample will be compared. Internationally accepted standard preparations of most biopharmaceuticals are available from organizations such as the World Health Organization (WHO) or the United States Pharmacopeia. 

U.S. Pharmacopeia (USP), 12 151, 16 701 suture standards of, 24 207 United States Pharmacopeia and National Formulatory, in fine chemical production, 11 435 U.S. proof, conversion of, 10 549t U.S. steel products, net shipments of,... 

The United States Pharmacopeia describes a pyrogen test using rabbits as a model (USP, 1995b). This test, which is the standard for limiting risks of a febrile reaction to an acceptable level, involves measuring the rise in body temperature in a group of three rabbits for 3 h after injection of 10 ml of test solution. 

Department of Standards Development, United States Pharmacopeia, Rockville, Maryland, U.S.A. 

Pharmaeopeial harmonization is challenging. Differences exist because of the different histories of the pharmacopoeias. There are many factors. The most obvious are content, language, legalities, speed, and the audiences for the standards. United States Pharmacopeia applies also to the practice of pharmacy, both in a com-... 

The United States Pharmacopeia, or USP (Figure 5.19), publishes methods for the pharmaceutical industry. The publication is called the United States Pharmacopeia — National Formulary, or USP-NF. It is published every 5 years and is a resource for drug standards and for ensuring the quality of... 

General standards for drugs are typically published in the so-called national pharmacopoeia. The names of the different national pharmacopoeia are formed by pharmacop(o)eia combined with the name of the country, for example, the United States Pharmacopeia and National Formulary (USP-NF). Attempts to generalize and unify the different national pharmacopoeia have continued for over a century. The European Community signed a convention that resulted in issuance of the European Pharmacopoeia [11 ]. Finally, the WHO (United Nations World Health Organization) publishes a Pharmacopoeia Internationalis [12]. 

At the present time the United States Pharmacopeia (USP) is the premier book of pharmaceutical standards throughout the world. It is enforced as the book of drug standards and is used by the FDA to define quality in the United States during inspections and reviews. 

United States Pharmacopeia, General Chapters Physical Tests and Determinations <711 > Dissolution, Official Compendia of Standards, USP 25, NF 20, p. 2011, 2002. 

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