United States Pharmacopeia meetings

Talc sold to the cosmetics and baby powder markets must meet the Cosmetic, Toiletries and Fragrance Association (CTFA) specifications (8). For mote stringent appHcations there ate United States Pharmacopeia (USP) and Pood Codex specifications. 

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. 

Calcium carbonate is one of the most versatile mineral fillers (qv) and is consumed in a wide range of products including paper (qv), paint (qv), plastics, mbber, textiles (qv), caulks, sealants (qv), and printing inks (qv). High purity grades of both natural and precipitated calcium carbonate meet the requirements of the Food Chemicals Codex and the United States Pharmacopeia and are used in dentifrices (qv), cosmetics (qv), foods, and pharmaceuticals (qv). 

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. 

Founded in Tokyo in September 1989 as the Quadripartite Group, the Pharmacopeial Discussion Group (PDG) was originally composed of representatives of the British, European, Japanese, and U.S. Pharmacopeias. The current group includes members from the European, Japanese, and United States Pharmacopeias. At its first meeting at USP headquarters in Rockville, MD, in March 1990, important agreements were reached ... 

This chapter will deal with the objective of manufacturing excipient ingredients to appropriate good manufacturing practices (GMP) requirements, as stipulated by the United States Pharmacopeia (USP) (1) and the International Pharmaceutical Excipients Council excipient GMP guide (2). It is beyond the scope to address the many quality techniques for minimizing variation in excipient quality. However this chapter will address the issues concerning assurance that all excipient material within each batch meets compendial or manufacturer s specification. 

Batch failure of the drug product does not necessarily occur when an individual test result does not meet the specifications outlined in the United States Pharmacopeia (USP), manufacturers new drug application (NDA), or abbreviated new drug application (ANDA). Additionally, an OOS result identified through a thorough laboratory investigation as laboratory error is not necessarily a batch failure. 

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... 

Other designations of chemical purity include Chemically Pure (CP) USP and NF Grade (chemicals produced to meet specifications set down in the United State Pharmacopeia lUSP] or the National Formulary [NF]). Chemicals labeled purified, practical, technical, or commercial grade should not be used in clinical chemical analysis without prior purification. 

Food/medicinal oils are frequently referred to as meeting United States Pharmacopeia (USP) or National Formulary (NF) specifications, usually written as meets USP/NF specifications. USP and NF specifications differ only in specific gravity and viscosity. USP oils must have specific gravities between 0.845 and 0.905 at 25°C and have viscosities greater than 34.5 cSt at 40°C. NF oils must have viscosities less than 33.5 cSt at 40°C and must have densities between 0.818 and 0.880 at 25°C. Further details on specifications are provided later. 

Pharmaceutical or chemical equivalence means that two or more drug products contain equal amounts of the same therapeutically active ingre-dient(s) in identical dosage forms, and that these dosage forms meet the requirements such as purity, content uniformity and disintegration time as established by the United States Pharmacopeia and/ or National Formulary. 

Considerable interest has been shown in poly(ethylene oxide) for diverse applications in food, drug, and cosmetic products. Such uses fall within the scope of the Federal Food, Drug, and Cosmetic Act. The U.S. Food and Drug Administration (FDA) has recognized and approved the use of poly(ethylene oxide) for specific food and food packaging uses. USP/NF grades of Polyox water-soluble resins (The Dow Chemical Co.) that meet all requirments of the United States Pharmacopeia/National Formulary (USP/NF) are available for pharmaceutical applications (105). 

Not required for synthesized air when oxygen component was produced by air liquefaction and meets United States Pharmacopeia (USP) specification [1]. 

Nitrous oxide is available in medical, commercial, and high-purity grades. The medical (USP) grade is the most widely used. Manufacturers typically produce nitrous oxide for this use to the specification published in the United States Pharmacopeia/National Formulary [1]. CGA G-8.2, Commodity Specification for Nitrous Oxide, describes the requirements for particular grades of nitrous oxide [2]. Other specifications to meet particular requirements are available from suppliers. Table 1 from CGA G-8.2 presents the component maxima, in parts per million... 

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