The USP stipulates qualitative and quantitative biological assays for the determination of the identity and activity of insulin. Insulin products marketed in the United States must, as a rule, comply with these requirements. The test according to USP <121> was established at Labor LS in 2005 and has been inspected by the FDA.
For further information and questions, we are happy to answer your questions at +49 (0)9708/9100-280.
Press release dated 23 April 2018
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