Stability of ethacrynate sodium after reconstitution in 0.9% sodium chloride injection and storage in polypropylene syringes for pediatric use.

The stability of ethacrynate sodium (1 mg/mL) in 0.9% sodium chloride injection has been studied at 25 deg C and 5 deg C in polypropylene syringes by using a stability-indicating high-performance 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 25 deg C, there was no loss in potency after 14 days of storage or at 5 deg C 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.