FDA approves Teva Pharmaceuticals’ CU method

By The Science Advisory Board staff writers

July 7, 2022 -- The U.S. Food and Drug Administration (FDA) approved a content uniformity (CU) method from Teva Pharmaceuticals that uses the Agilent TRS100 Raman quantitative pharmaceutical analysis system.

As an Agilent Raman spectroscopy customer, Teva Pharmaceuticals developed a method of CU that determines how much active pharmaceutical ingredient (API) is inside a tablet or capsule and whether the API is uniform across a batch. The method is a fast, whole-sample analysis that negates the sample preparation stages and allows the test to be completed in a matter of minutes, Teva Pharmaceuticals said.


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