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USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
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.
The Articles of Confederation, ratified by the colonies in 1781, provided: . The United States in Congress assembled shall also have the sole and exclusive right and power of regulating the alloy and value of coin struck by their own authority, or by that of the respective states—fixing the standards of weights and measures throughout the United States.
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)
ACS grade is the highest level of purity, and meets the standards set by the American Chemical Society (ACS). The official descriptions of the ACS levels of purity is documented in the Reagent Chemicals publication, issued by the ACS. [3] [4] It is suitable for food and laboratory uses. Reagent grade is almost as stringent as the ACS grade.
Certified reference materials (CRMs) are 'controls' or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. [1] A certified reference material is a particular form of measurement standard.
A primary standard in metrology is a standard that is sufficiently accurate such that it is not calibrated by or subordinate to other standards. Primary standards are defined via other quantities like length, mass and time. Primary standards are used to calibrate other standards referred to as working standards. [1] [2] See Hierarchy of Standards.