Chemical Stability of Dexamethasone Sodium Phosphate After Reconstitution in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes
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Abstract: The chemical stability of dexamethasone sodium phosphate
(1 mg/mL and 0.1 mg/mL) in 0.9% sodium chloride injection
was studied at 25°C in polypropylene syringes 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 5 injections was 1.5. The benzyl alcohol
did not interfere with the assay procedure at 278 nm.
The products of decomposition separated from the intact
drug. At a concentration of 1 mg/mL, the loss in potency
was l% after 22 days of storage and less than 3% at a concentration
of 0.1 mg/mL after storage for 22 days. The pH
value of the injection (1 mg/mL) decreased from 7.3 to 7.2
after 22 days of storage and from 6.5 to 6.3 in the 0.1-
mg/mL sample. The physical appearance of the injection
did not change.
Related Keywords:
Dexamethasone sodium phosphate, reconstituted, stability of during storage
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