Stability of Ethacrynate Sodium After Reconstitution in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes for Pediatric Use
Author(s): Gupta Vishnu D, Ling Jie
Issue: Jan/Feb 2001 - Compounding for Pediatric Patients
View All Articles in Issue
Page(s): 73-75
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Abstract: The stability of ethacrynate sodium
(1 mg/mL) in 0.9% sodium chloride injection
has been studied at 25ºC and
5ºC in polypropylene syringes by
using a stability-indicating highperformance
liquid chromatography
assay method. The concentrations of
the drug were directly related to peak
heights, and the percent relative standard
deviation based on 5 injections
was 1.6. Mannitol, which is added as an
excipient in the injection, did not interfere
with the assay procedure. Two
products of decomposition separated
from the intact drug. At 25ºC, there
was no loss in potency after 14 days of
storage or at 5ºC after 22 days of storage.
The pH value (6.5) of the injection
remained constant throughout
the study period. The drug was not
adsorbed onto the syringes, and the
physical appearance of the injection
did not change.
Related Keywords:
ethacrynate, ethacrynate injection, stability, storage
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