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Chemical Stability of Methylprednisolone Sodium Succinate After Reconstitution in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes

Author(s):  Gupta Vishnu D

Issue:  Mar/Apr 2001 - Compounding for Animals
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Abstract:  The chemical stability of methylprednisolone sodium succinate (10 mg/mL) in 0.9% sodium chloride injection has been studied at 25°C and 5°C in polypropylene syringes by means of a stability-indicating high-performance liquid chromatography assay method. The concentrations of the drug were directly related to the peak height, and the percent relative standard deviation based on five injections was 1.2. Benzyl alcohol, which is added as a preservative, did not interfere with the assay. Two products of decomposition separated from the intact drug. At 25°C, the loss of potency was less than 10% after 4 days of storage. At 5°C, the loss of potency was less than 5% when the injection was stored for 21 days. After 17 days of storage at 25°C, the pH value of the injection decreased from 7.2 to 6.5, and there was no change in the pH value when the injection was stored for 21 days at 5°C. The drug did not adsorb onto the syringes, and the physical appearance of the injection did not change.

Related Keywords: methylprednisolone injection, methylprednisolone stability


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