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Stability of Hydrocortisone Sodium Succinate After Reconstitution in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes for Pediatric Use

Author(s):  Gupta Vishnu D, Ling Jie

Issue:  Sep/Oct 2000 - Compounding for Immune System Disorders
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Abstract:  The stability of hydrocortisone 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 concentration of the drug was directly related to the peak height, and the percent relative standard deviation based on 5 injections was 1.2. Benzyl alcohol, which was added as a preservative, did not interfere with the assay procedure. Two products of decomposition separated from the intact drug. At 25°C, the loss in potency was less than 10% after 7 days of storage. At 5°C, it was less than 3% when stored for 21 days. The pH value of the injection decreased from 7.2 to 6.3 when stored at 25°C for 21 days and from 7.2 to 7.0 when stored at 5°C for 21 days. The drug did not adsorb onto the syringes, and the physical appearance of the injection did not change.

Related Keywords: stability, hydrocortisone, storage, reconstitution, assay, chromatographic, chromatography

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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