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Chemical Stability of Dexamethasone Sodium Phosphate After Reconstitution in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes

Author(s):  Gupta Vishnu D

Issue:  Sep/Oct 2002 - Veterinary Compounding
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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

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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