Amphastar Pharmaceuticals, Inc.

Jie Fei Ding

Jack Yongfeng Zhang

Mary Ziping Luo

Aili Bo

Mary Zi-Ping Luo

Mary Zi-ping Luo

Dingyuan Fei

Zhongli Bao

Kevin Xie

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.

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

Pharmaceutical compositions for long-term sustained release of bisphosphonate drugs are provided. In one embodiment, the composition includes an aqueous suspension of a solid which includes a salt of a bisphosphonate drug and a salt of pentavalent phosphorus oxoacid. The compositions can be used to treat a variety of bone diseases, including osteoporosis.

Long term sustained release pharmaceutical composition containing aqueous suspension of bisphosphonate

A sterile, stable pharmaceutical formulations of oil-in-water emulsions of Propofol containing no preservative are provided that comprise optimal amounts of egg lecithin and soybean oil, with a suitable pH range to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination. The lower pH in the formulation has shown the most antimicrobial activity. The reduced amount of fat in the formulation also allows chronic sedation over extended periods of time with a reduced chance of fat overload in the blood.

Propofol formulation with enhanced microbial inhibition

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Riverside, CA, United States of America

Jie Fei Ding