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USP-NF standards also have a role in US federal law; a drug or drug ingredient with a name recognized in USP-NF is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity. USP also sets standards for dietary supplements and food ingredients (as part of the Food Chemicals Codex).
USP grade meets the purity levels set by the United States Pharmacopeia (USP). USP grade is equivalent to the ACS grade for many drugs. NF grade is a purity grade set by the National Formulary (NF). NF grade is equivalent to the ACS grade for many drugs. British Pharmacopoeia: Meets or exceeds requirements set by the British Pharmacopoeia (BP ...
The ingredient name is often followed by the initials NF, indicating that it conforms to the specifications of the National Formulary. Emulsifying wax is created when a wax material (either a vegetable wax of some kind or a petroleum-based wax) is treated with a detergent (typically sodium dodecyl sulfate or polysorbates ) to cause it to make ...
In the U.S., the USP-NF (United States Pharmacopeia – National Formulary) has been issued by a private non-profit organization since 1820 under the authority of a Convention that meets periodically that is largely constituted by physicians, pharmacists, and other public health professionals, setting standards published in the compendia ...
USP started the online version of the FCC since 2008. The FCC is published every two years in print and online formats and is offered as a subscription that includes a main edition and intervening supplements. All proposed standards and revisions for the FCC are first posted in the free, online FCC Forum for a 90-day public comment period.
Pharmacopoeial reference standards are a subset of pharmaceutical reference standards. They are established for the intended use described in pharmacopeial texts (monographs and general chapters). Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where ...
United States National Formulary, later bought out and merged with the United States Pharmacopeia (USP-NF) Farmaceutiska Specialiteter i Sverige (FASS), the Swedish national formulary. Usage of the database is free of charge and it has no promotional texts or advertising. [15]
In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. [6] They are: USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5 °C ) USP Dissolution Apparatus 2 – Paddle (37 °C ± 0.5 °C) USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5 °C)