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Stability of Dobutamine Hydrochloride 4 mg/mL in 5% Dextrose Injection at 5 and 23 degrees C

Author(s):  Webster Andrew A, English Brett A, McGuire J Michael, Riggs Robert M, Lander Vickie, Buckle Thomas

Issue:  Sep/Oct 1999 - Natural Hormone Replacement Therapy
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Page(s):  412-414

Stability of Dobutamine Hydrochloride 4 mg/mL in 5% Dextrose Injection at 5 and 23 degrees C Page 1
Stability of Dobutamine Hydrochloride 4 mg/mL in 5% Dextrose Injection at 5 and 23 degrees C Page 2
Stability of Dobutamine Hydrochloride 4 mg/mL in 5% Dextrose Injection at 5 and 23 degrees C Page 3

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Abstract:  The stability of dobutamine hydrochloride 4 mg/mL in 5% dextrose injection has been studied using a stability-indicating, high-performance liquid chromatography assay method. The admixture injections were stable for 30 days at 5 and 23°C. Concentrations ranged between 98.5% and 102.6% for the room-temperature samples, and 99.6% and 101.8% for the refrigerated samples, of the initial mean concentrations. The standard curves demonstrated linearity (r2>.999). Variations within and between days were less than 3%. None of the samples appeared to form a visible precipitate or changed in color or clarity and the pH of the samples remained between 3.5 and 3.7.

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