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Argatroban Injection is supplied in 2.5-mL solution in single-use vials at the concentration of 100 mg/mL. Each vial contains 250 mg of Argatroban.[2]
Stability/compatibilityArgatroban is a clear, colorless to pale yellow, slightly viscous solution.[2] If the solution is cloudy or if an insoluble precipitate is noted, the vial should be discarded.Solutions prepared as recommended are stable at 25°C (77°F) (permitted range: 15°C to 30°C [59°F to 86°F]) in ambient indoor light for 24 hours; therefore, light-resistant measures such as foil protection for intravenous lines are unnecessary.[2] Solutions are physically and chemically stable for up to 96 hours when protected from light and stored at controlled room temperature, 20°C to 25°C (68°F to 77°F) (see USP), or at refrigerated conditions, 5°C ± 3°C (41°F ± 5°F). Prepared solutions should not be exposed to direct sunlight. No significant potency losses have been noted following simulated delivery of the solution through intravenous tubing. |