The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Dec. 13, 2022
Filed:
Sep. 25, 2019
Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA (US);
Jie Fei Ding, Riverside, CA (US);
Aili Bo, La Verne, CA (US);
Jack Yongfeng Zhang, Diamond Bar, CA (US);
Mary Zi-ping Luo, Diamond Bar, CA (US);
Zhongli Bao, Chino Hills, CA (US);
AMPHASTAR PHARMACEUTICALS, INC., Rancho Cucamonga, CA (US);
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-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.