Epinephrine compositions and containers
AssigneeNevakar Injectables Inc.
InventorsPrem Sagar AKASAPU, Kumaresh SOPPIMATH, Reema Ajitkumar PURI, Iouri V. ILITCHEV, Milan PATEL, Pooja H. TENDULKAR
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AssigneeNevakar Injectables Inc.
InventorsPrem Sagar AKASAPU, Kumaresh SOPPIMATH, Reema Ajitkumar PURI, Iouri V. ILITCHEV, Milan PATEL, Pooja H. TENDULKAR
Estimating the term…
A sterile storage stable ready-to-inject epinephrine composition contained within a flexible container and packaged within a secondary container, the composition including an aqueous pharmaceutically acceptable carrier containing epinephrine and a metal ion chelator, the epinephrine being present in a concentration of equal to or less than 0.07 mg/mL, substantially all of the epinephrine being an R-isomer, the composition having a pH of between 3.5-4.7, and the composition having, after storage of at least one month at 25° C., total impurities of equal or less than 0.7% and equal or less than 4% S-isomer content.
A sterile storage stable ready-to-inject epinephrine composition contained within a flexible container and packaged within a secondary container,
Dependencies are inferred from the claim text.