WebDec 10, 2003 · It is the opinion of the Author that U.S. Pharmacopeia Testing per Class VI (one part of USP <88> testing), is not alone sufficient in determining the biological reactivity to that material. Additionally, the materials should be tested in accordance with USP <87>, in vitro testing with mammalian cells, to better determine potential ... WebUSP <87> Biological Reactivity Tests –. In Vitro. We offer market-leading expertise in cytotoxicity assays. Our scientists use cell culture assays to assess the biocompatibility of a material or extract through an in vitro reaction of mammalian cells following exposure. These may be plastics or elastomers used as containers or to seal ...
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WebLearn more! 〈87〉 Biological Reactivity Tests, In Vitro. The following tests are designed to determine the biological reactivity of mammalian cell cultures following contact with the … WebJun 21, 2024 · If the Biological Reactivity Tests, In Vitro <87> fail, the recommendation is to perform Biological Reactivity Tests, In Vivo <88>; for products where USP <88> … high falls tennessee
Biological Reactivity Testing What Does It Imply - Docest
WebThree in vitro cytotoxicity tests are used to assess systemic biological reactivity without the need for in vivo animal testing. These tests are direct contact, agar diffusion, and elution … WebThe USP <87> test is designed to determine the biological reactivity of mammalian cell cultures following direct or indirect contact with the test article or from specific extracts … Webthe biological in vivo testing (systemic injection, intra-cutaneous, and implantation tests). In 1988, in vitro tests were explored, and USP concluded that in vitro assay(s) could serve as a decision point as to whether or not a sample would be tested in animals. In 1990, USP XXII added <87> Biological Reactivity Tests, to the Compendia. how high does ph scale go