U.S. Pharmacopeia

Bacterial Endotoxias Test (85)," "Biological Reactivity Tests, in vivo (88)," "Particulate Matter ia Injections (788)," and "Purified Water," JJSP 23 The U.S. Pharmacopeia Convention, RockviUe, Md., 1994. 

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. 

In 1949 the World Health Organization adopted the biological activity of 1 mg of an oil solution containing 0.025 p.g of crystalline D as the analytical standard for vitamin D. This standard was discontinued in 1972. USP uses crystalline cholecalciferol as a standard (80). Samples of reference standard may be purchased from U.S. Pharmacopeia Convention, Inc., Reference Standards Order Department, 12601, Twinbrook Parkway, Rockville, Maryland 20852. One international unit of vitamin D activity is that activity demonstrated by 0.025 ]1 of pure crystalline (7 -vitamin D. One gram of vitamin D3 is equivalent to 40 x 10 lU or USP units. The international chick unit (ICU) is identical to the USP unit. 

The United States Pharmacopeia, 22nd ed., U.S. Pharmacopeia Convention, Rockville, Md., 1989. 

U.S. Pharmacopeia National Formulary. (1995) U.S. Pharmacopoeia Convention Inc., Rockville, MD. 

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... 

X-ray powder patterns can be obtained using either a camera or a powder diffractometer. Currently, diffractometers find widespread use in the analysis of pharmaceutical solids. The technique is usually nondestructive in nature. The theory and operation of powder diffractometers is outside the purview of this chapter, but these topics have received excellent coverage elsewhere [1,2]. Instead, the discussion will be restricted to the applications of x-ray powder diffractometry (XPD) in the analysis of pharmaceutical solids. The U.S. Pharmacopeia (USP) provides a brief but comprehensive introduction to x-ray diffractometry [3],... 

In many respects, differential scanning calorimetry (DSC) is similar to the DTA method, and analogous information about the same range of thermal events can be obtained. However, DSC is far easier to use routinely on a quantitative basis, and for this reason it has become the most widely used method of thermal analysis. The relevance of the DSC technique as a tool for pharmaceutical scientists has been amply documented in numerous reviews [3-6,25-26], and a general chapter on DSC is documented in the U.S. Pharmacopeia [27]. 

U.S. Pharmacopeia and FDA, 78 701 uses of succinic acid and succinic anhydride in, 23 428t Pharmaceutical separation... 

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,... 

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. 

Prepare 500 mL of a 2% solution of carboxymethylcellulose, sodium salt, in water in the manner described in the U.S. Pharmacopeia reference above. Since the solution preparation is time-consuming, your instructor may prepare it ahead of time. Using a rotational viscometer with an appropriate spindle and a constant temperature bath, measure the viscosity of this solution at various temperatures. Plot viscosity vs. temperature. 

All FDA-approved drugs products must meet the quality requirements described in the U.S. Pharmacopeia (USP) (1,2). If a drug product is to be manufactured elsewhere in the world but marketed in the United States, compliance with existing USP-NF monographs is crucial. Non-compliance may result in the FDA blocking entry of the product into the U.S. market or removing the product from the market. For other markets compliance with USP standards is not binding. For... 

Since the U.S. Congress passed Dietary Supplement Health and Education Act in October 1994, the landscape of the dietary supplement industry has changed in the United States dramatically. In fact, as early as the late 1980s, the U.S. Pharmacopeia s elected Council of Experts (then known as the USP Committee of Revision) was evoking great interest in the development and establishment of public standards for the multitude of multivitamin and multivitamin-mineral combination products as well other nutritional supplement products marketed in the United States. 

Todd Cecil (359) U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852 USA... 

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