United States Pharmacopeia/National Formulary

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. 

United States Pharmacopeial Convention, Fourth Supplement of the United States Pharmacopeia— National Formulary, United States Pharmacopeial Convention, Rockville, MD, 1988, pp. 2249-2250. 

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... 

Another source of very useful excipient data is the United States Pharmacopeia-National Formulary (USP-NF). Despite certain limitations, it appears that this compendium may become more useful in the years to come. 

See cuirent United States Pharmacopeia/National Formulary, section <711 >, for general dissolution specifications. All profiles should be conducted on at least 12 individual dosage units. 

United States Pharmacopeia, National Formulary XVIII, United States Pharmacopoeial Convention, Inc., Rockville, MD, pp. 2215-2216(1995). 

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... 

United States Pharmacopeia/National Formulary (USP/NF) magnesium silicate... 

United States Pharmacopeia/National Formulary (USP 23/NF 18) 1995. Water Determination. Rockville, MD U.S. Pharmacopeial Convention, Inc., 1995, pp. 1840-1842. 

United States Pharmacopeia, National Formulary, 24th... 

Throughout this article, the abbreviation USP, when used alone, signifies the United States Pharmacopeial Convention, Inc. The abbreviation USP in italics and followed by Roman numerals signifies a particular revision of the United States Pharmacopeia. The abbreviation USP-NF signifies the United States Pharmacopeia-National Formulary, two books in a single binding. 

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. 

The United States Pharmacopeia National Formulary is a book that contains strength and purity standards for the manufacturing and control of medication. A medication that is listed in the United States Pharmacopeia National Formulary has the letters U.S.P. following its official name. 

Several years after the successful launch of a new product, it is typical for North American pharmaceutical firms to become involved in the United States Pharmacopeia-National Formulary (USP-NF) revision process to allow inclusion of their API and formulations in the USP-NF. The USP-NF and their supplements are a compilation of monographs prepared under the authority of the Pharmacopeial Convention. The purpose of the USP-NF and supplements is to provide authoritative standards and specifications for materials and substances and their preparations that are used in health care or for the improvement or maintenance of health.16 The revision process— as outlined in the USP-NF—begins with inquiries, comments and suggestions for revision in the USP-NF text mailed directly to the USP.17 Participation in this process ensures consideration of the innovator s methods, specifications, and reference standards for inclusion in the USP-NF. Approval for inclusion in the USP-NF is gained after consideration by an Expert Committee of the USP Council of Experts. If the Expert Committee so recommends, the proposed revision is published in the Pharmacopeial Forum (PF) for review and comments by interested readers of the PF. The comments and data submitted by interested readers are reviewed and addressed, and the Expert Committee then decides whether to recommend to the USP Council of Experts that the proposed revision should be adopted in the USP-NF. 

U.S. Code Annotated United States Department of Agriculture United States Pharmacopeia U.S. Pharmacopeial Convention United States Pharmacopeia-Drug Information United States Pharmacopeia-National Formulary Uniformed Services University of the Health Sciences... 

USP/NF United States Pharmacopeia/National Formulary, BP British Pharmacopoeia, EP European Pharmacopoeia, CTFA Cosmetic Toiletry and Fragrance Cosmetic Ingredient Dictionary, CA Codex Alimentarius (F.A.O.). 

The United States Pharmacopeia (USP) is a nongovernmental organization that sets pubhc standards for prescription and over-the-counter medicines, health care products, food ingredients, and dietary supplements. The USP dictates the quality, strength, purity, and consistency of these products if they are sold in the United States. The United States Pharmacopeia-National Formulary (USP-NF) presents standards for all drug products, dietary... 

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). 

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... 

The USP and NF standards give the basic measures required for medical gas strength, quality, and purity. The United States Pharmacopeia/National Formulary is available from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, Maryland 20852. The USP and NF standards include requirements for packaging, labeling, identification, impurity levels, and assay procedures for certain medical gases. 

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