Stability of Cefepime Hydrochloride After Reconstitution in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes for Pediatric Use
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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.
Related Keywords:
cefepime, cefepime injection, cefepime stability, cefepime storage
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