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Chemical Stability of Phenylephrine HCl After Reconstitution in 0.9% Sodium Chloride Injection for Infusion

Author(s):  Gupta Vishnu D

Issue:  Mar/Apr 2004 - Overview of USP Chapter <797>
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Abstract:  The chemical stability of phenylephrine hydrochloride (0.2 and 0.1 mg/mL) in 0.9% sodium chloride injection stored in polyvinyl chloride bags was studied at 25°C by means of a stability-indicating high-performance liquid chromatographic assay method. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on five injections was 1.0. The excipients present in the injection did not interfere with the assay procedure. The products of decomposition separated from the intact drug. At both concentrations (0.2 and 0.1 mg/mL), the loss in potency was less than 1.0% after 14 days of storage at room temperature. The pH value of the 0.2-mg/mL injection decreased from 4.3 to 4.0 after 14 days of storage, and the pH value of the 0.1-mg/mL injection decreased from 4.4 to 4.2. The physical appearance of the injection did not change.

Related Keywords: Gupta, Vishnu D, PhD, Phenylephrine hydrochloride, reconstituted for infusion, chemical stability of


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