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

Author(s):  Gupta Vishnu D

Issue:  May/Jun 2002 - Health, Wellness, Geriatrics
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Abstract:  A stability-indicating high-performance liquid chromatographic assay method was used to study the stability of cefotaxime sodium (50 mg/mL) in 0.9% sodium chloride injection in polypropylene syringes at 5°C and 25°C. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on 5 injections was 1.1. There were at least three products of decomposition that separated from the intact drug. At 5°C, the decomposition was less than 3% when stored for 18 days, and at 25°C, the loss in potency was less than 10% after 1 day of storage. When stored for 18 days at 5°C, the pH value decreased from 5.3 to 5.2. The pH value of the injection decreased from 5.3 to 5.0 when stored at 25°C for 1 day. The drug was not adsorbed onto the syringes, and the intensity of the light yellow color did not change significantly during storage at 5°C but increased during storage at 25°C.

Related Keywords: Cefotaxime sodium, stability of, Cefotaxime sodium, pediatric use of


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