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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.
In 2013, the first recommendations for auxiliary label usage in the United States were published as USP Chapter <17>. [4] This included a recommendation to limit the use of auxiliary labels to evidence-based labels with critical information, and without pictures unless evidence shows increased efficacy when a picture is used.
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)
USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".
The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products. [4] It is important when conducting these tests to ensure that the testing method does not either introduce bacteria into the test sample or kill bacteria in the test sample. [4]
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.
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