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

Gupta, Vishnu D; Ling, Jie

Abstract

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

Author(s): Gupta Vishnu D, Ling Jie

Issue: Mar/Apr 2001 - Compounding for Animals

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Page(s): 151-152

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Abstract

A stability-indicating high-performance liquid chromatography (HPLC) assay method was used to study the stability of cefepime hydrochloride (20 mg/mL) in 0.9% sodium chloride injection at 25°C and 5°C in polypropylene syringes. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on five injections was 1.1. L-arginine that is added to the powder for injection did not interfere with the assay. Two products of decomposition separated from the intact drug. At 25°C, the loss in potency was less than 6% after 2 days of storage, and at 5°C the loss in potency was less than 3% when stored for 21 days. The pH value of the injection did not change when stored at 25°C for 2 days and at 5°C for 21 days. The drug was not adsorbed onto the syringes, and the physical appearance of the injection did not change during 2 days of storage at 25°C and 21 days at 5°C.

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