U.S. Pharmacopeia- National Formulary USP-NF

The U.S. Food and Drug Administration (FDA) regulation 21 CFR 211.194(a)(2) specifically states that users of analytical methods in the U.S. Pharmacopeia/National Formulary (USP/NF) are not required to validate the accuracy and reliability of these methods but merely verify their suitability under actual conditions of use. USP... 

A regulatory analytical procedure is the analytical procedure used to evaluate a defined characteristic of the drug substance or drug product. The analytical procedures in the U.S. Pharmacopeia/National Formulary (USP/NF) are those legally recognized under section 501(b) of the Act as the regulatory analytical procedures for compendial items. 

Reference General Test <731>, U.S. Pharmacopeia-National Formulary, USP 24—NF 19,2000, p. 1954. Remember safety glasses. 

In the early 1900s, the U.S. Pharmacopeia, National Formulary had excellent quality control guidelines and safe dosages for hundreds of herbs [25]. Products that are labeled as conforming to the U.S. Pharmacopeia (USP) or National Formulary (NF) standards should be recommended whenever possible. A product labeled as USP indicates that the active ingredient has been approved by the FDA or, alternately, that the use has been accepted by the USP. If the label contains the NF designation, the product has been neither approved by... 

Throughout this article, the abbreviation USP, when used alone, signifies the U.S. Pharmacopeial Convention, Inc. The abbreviation USP followed by Roman numerals signifies a particular revision of the Pharmacopeia. The abbreviation USP-NF is used to signify the U.S. Pharmacopeia-National Formulary and are taken to be USP24 and NF19, unless otherwise specified. 

The USP was combined as a compendium with the National Formulary (NF) in 1975. Currently, the USP gives information regarding substances considered as having active medicinal properties while pharmaceutically inactive necessities are described in NF. The combined United States Pharmacopeia and National Formulary (USP-NF) is legally recognized under the U.S. Federal Food, Drug and Cosmetic Act. 

U.S. PHARMACOPEIA (USP) A non-profit organization that provides standards for prescription and over-the-counter drugs, nutritional and dietary supplements, and health care products. USP publishes its standards in the United States Pharmacopeia and the National Formulary (USP-NF), which are officially recognized by the U.S. Food and Drug Administration (FDA). USP also has a dietary supplement verification program (DSVP). 

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

U.S. Pharmacopeia XX, (USP XX-NF XV), The United States Pharmacopeial Convention Inc., Rockville, Md., 1980 National Formulary XIW, Amehcan Pharmaceutical Association, Washington, D.C., 1975. 

Reference General Test <905>, U.S. Pharmacopeia and National Formulary, USP 24-NF 19,2000,... 

USP/NF Reagents that meet the purity requirements of the U.S. Pharmacopeia (USP) and the National Formulary (NF). Generally of interest to the pharmaceutical profession, these specifications may not be adequate for reagent use. 

A statement of each method used in the testing of the sample. The statement must 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 used is in the current revision of the U.S. Pharmacopeia (USP), National Formulary (NF), or other recognized standard reference or if it is detailed in an approved NDA, this statement will not be required.)... 

Abbreviations PEG, polyethylene glycol USP, U.S. pharmacopeia NF, National formulary. 

The importance of selecting gravimetry instead of volumetry to measure liquid amounts in the pharmaceutical industry of liquid dosage forms is well illustrated by the volume contraction of water-ethanol and volume expansion of ethyl acetate-carbon disulfide liquid mixtures as well as a CS2-ethyl acetate system. The National Formulary (NF) diluted alcohol is a typical example of the volume nonadditivity of liquid mixtures [29], This solution is prepared by mixing equal volumes of alcohol [U.S. Pharmacopeia (USP)] USP and purified water (USP). The final volume of this solution is about 3% less than the sum of the individual volumes because of the contraction due to the mixing phenomenon [1], In addition, molecular interactions of surfactants in mixed monolayers at the air-aqueous solution interface and in mixed micelles in aqueous media also cause some contraction of volume upon mixing [30],... 

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