Phenylephrine hydrochloride ready-to-use solution

A stable, ready-to-use sterile intravenous injection solution of phenylephrine hydrochloride packaged into a vial for injection, wherein the solution consists essentially of:

• from about 0.05 mg/mL to about 0.15 mg/mL phenylephrine hydrochloride as the only active pharmaceutical ingredient in the solution;
• from about 0.1 mg/mL to about 0.3 mg/mL of edetate disodium (EDTA);
• one or more of a preservative, a buffer and/or a pH adjustor;
• sodium chloride;
• and
• water;
• wherein the solution has a pH between 3 and 6.5, is stored in a single use vial, and exhibits 0.2% or less of phenylephrine impurities after exposure to a temperature of 40° C. for a period of 6 months;
• and
• wherein the solution is free of bisulfites or other antioxidants.

A sterile liquid pharmaceutical product that includes a stable, ready-to-use sterile intravenous injection solution of phenylephrine hydrochloride packaged into a vial for injection, the vial having less than 10% by volume oxygen content in a head space of the vial, wherein the solution consists essentially of:

• from about 0.05 mg/mL to about 0.15 mg/mL phenylephrine hydrochloride as the only active pharmaceutical ingredient in the solution;
• from about 0.1 mg/mL to about 0.3 mg/mL of edetate disodium (EDTA);
• sodium chloride;
• and
• water;
• wherein the solution has a pH between 3 and 6.5, is stored in a single use vial, and exhibits 0.2% or less of phenylephrine impurities after exposure to a temperature of 40° C. for a period of 6 months;
• and wherein the solution is free of bisulfites or other antioxidants.

A stable, ready-to-use sterile intravenous injection solution of phenylephrine hydrochloride packaged into a vial for injection, wherein the solution consists essentially of:

• from about 0.05 mg/mL to about 0.15 mg/mL phenylephrine hydrochloride as the only active pharmaceutical ingredient in the solution;
• from about 0.1 mg/mL to about 0.3 mg/mL of edetate disodium (EDTA);
• sodium chloride;
• and
• water;
• wherein the solution is stored in a single use vial and exhibits 0.2% or less of phenylephrine impurities after exposure to a temperature of 40° C. for a period of 6 months;
• and wherein the solution is free of bisulfites or other antioxidants.