Amphastar Pharmaceuticals, Inc.
HIGHLY PURIFIED RECOMBINANT HUMAN INSULIN (RHI) API AND METHODS OF PRODUCING THE SAME

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Abstract:

Methods are disclosed for producing highly purified recombinant human insulin (RHI) having a purity of 99.0% (w/w) or greater, a Total Impurity (not including the related substance desamido Asn.sup.A21-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.

Status:
Application
Type:

Utility

Filling date:

25 Sep 2019

Issue date:

9 Jul 2020