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  2. Chemical purity - Wikipedia

    en.wikipedia.org/wiki/Chemical_purity

    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.

  3. United States Pharmacopeia - Wikipedia

    en.wikipedia.org/wiki/United_States_Pharmacopeia

    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.

  4. USP 800 - Wikipedia

    en.wikipedia.org/wiki/USP_800

    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".

  5. DEPARTMENT OF HEALTIl AND HUMAN SERVICES FOOD AND DRUG ...

    highline.huffingtonpost.com/miracleindustry/...

    approval any raw material component that contained 1I1mown". contamination of gram negative organisms. Raw lots 0 had lmown contamination with gram negative organisms and were approved for use to manufacture several fmished lots of Children's and Infant's Tylenol drug products, which remain wit . ., th keto

  6. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]

  7. Bioburden - Wikipedia

    en.wikipedia.org/wiki/Bioburden

    The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden ...

  8. Food Chemicals Codex - Wikipedia

    en.wikipedia.org/wiki/Food_Chemicals_Codex

    Monographs may also detail USP Reference Standards and/or other materials needed for test performance. The FCC's appendices contain step-by-step guidance for general physical and chemical tests, and apparatus use, as well as generally useful information, such as food ingredient good manufacturing practices .

  9. Dissolution testing - Wikipedia

    en.wikipedia.org/wiki/Dissolution_testing

    In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]

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