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KMID : 0869619970140040321
Journal of Korean Society of Hospital Pharmacists
1997 Volume.14 No. 4 p.321 ~ p.327
Stability of Dexamethasone in Extemporaneous Suspension





Abstract
The stability of a dexamethasone disodium phosphate in suspension was studied. Suspensions of dexamethasone disodium phosphate were prepared from commercially available amples (Dexamethasone suspension ¥°) and from bulk powder (Dexamethasone suspension ¥±) to yield a suspension with a theoretical dexamethasone disodium phosphate concentration of 0.5§·/§¢.
The suspension was divided into portion and stored in plastic bottles under fluorescent light or in light - protective vinyl package at room temperature (25¡¾1¡É) or refrigerated temperature(4¡¾1¡É) for 6 months. The concentration of dexamethasone disodium phosphate in the samples was determined by a stability - indicating High Performance Liquid Chromatographic (HPLC) assay at 0, 1, 2, 4 and 6 months. Also at these times, the pH of the sample was measured and the samples were inspected for evidence of the color, odor and microbial growth.
The concentration of dexamethasone disodium phosphate in the samples remained more than 90% of the initial concentration throughout the study period. No important change of the color and odor in the samples were noted throughout the study period. No important change in the pH of the samples were noted for 6 months under all storage conditions. Visible evidence of microbial growth was noted in dexamethasone suspension ¥± stored at room temperature on 4 months. This extemporaneous suspension of dexamethasone disodium phosphate prepared form bulk powder and from commercially available injections is stable for at least 4 months when stored in light - protective vinyl package at refrigerated temperature.
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