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

Author(s):  Gupta Vishnu D

Issue:  Jul/Aug 2003 - After the Women's Health Initiative Trial
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Abstract:  The stability of cefuroxime sodium (50 mg/mL) in 0.9% sodium chloride injection stored in polypropylene syringes was studied at 25 and 5ºC 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 five injections was 0.9. There were at least two products of decomposition that separated from the intact drug. The loss in potency was less than 10% after 2 days of storage at 25ºC, and the loss in potency was less than 4% after 21 days of storage at 5ºC. The pH value increased from 6.9 to 7.3 when the injection was stored at 25ºC for 2 days, and the pH value increased from 6.9 to 7.0 when the injection was stored at 5ºC for 21 days. The drug was not adsorbed onto the syringes. The intensity of the lightyellow color increased with the storage period at 25ºC but did not change significantly with storage at 5ºC.

Related Keywords: Cefuroxime sodium, stability of, for pediatric use, Stability of cefuroxime sodium for pediatric use


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