Highly purified recombinant human insulin (RHI) API and methods of producing the same

Highly purified recombinant human insulin (RHI) API and methods of producing the same

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 AsnA21-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclose...

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Bibliographische Detailangaben
Hauptverfasser: Luo, Mary Zi-ping, Ding, Jie Fei, Bao, Zhongli, Zhang, Jack Yongfeng, Bo, Aili
Format: Patent
Sprache:eng
Schlagworte:
CHEMISTRY
METALLURGY
ORGANIC CHEMISTRY
PEPTIDES
PERFORMING OPERATIONS
PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
SEPARATION
TRANSPORTING
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Beschreibung
Zusammenfassung: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 AsnA21-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.