Norepinephrine compositions and methods therefor

A method of preparing a sterile, ready-to-administer norepinephrine composition, comprising the steps of:

• (a) combining norepinephrine or a salt thereof, a chelating agent, a tonicity adjusting agent, and an aqueous acidic solution to form a liquid parenteral composition, wherein the norepinephrine comprises at least 95% of R-isomer of norepinephrine, wherein the norepinephrine or salt thereof is present in the liquid parenteral composition in an amount of between 10 μg/ml and 100 μm/ml, wherein the chelating agent is present in the liquid parenteral composition in an amount of between 1 μg/ml and 100 μm/ml, and wherein the tonicity adjusting agent is present in the liquid parenteral composition in an amount of between 0.6 wt % and 1.2 wt %;
• (b) adjusting the pH of the liquid parenteral composition to a pH range of between 3.7 and 4.3;
• (c) filling the liquid parenteral composition into a container;
• and
• (d) heat sterilizing the liquid parenteral composition in the container to sterility to form the sterile, ready-to-administer norepinephrine composition;
• wherein the sterile, ready-to-administer norepinephrine composition is substantially free of antioxidants;
• and
• wherein the sterile ready-to-administer norepinephrine composition comprises at least about 90% R-isomer of norepinephrine after storage at 25±2° C. and 60±5% relative humidity, over at least three months as determined by HPLC.