Chemical Stability of Phenylephrine HCl After Reconstitution in 0.9% Sodium Chloride Injection for Infusion
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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:
Phenylephrine hydrochloride, reconstituted for infusion, chemical stability of
Related Categories:
INFUSION, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS
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