Using Metabolite Data to Develop Patient Centric Specification for Amide Impurity in Vildagliptin Tablets
Many specified impurities in vildagliptin's finished product have been disclosed in the literature that are above their qualification threshold. We used the impurity B (amide impurity) as a case example to explore whether existing literature can be leveraged to determine the safe level of impur...
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MDPI AG,
2021-12-01T00:00:00Z.
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