Stability of nafcillin sodium after reconstitution in 0.9% sodium chloride injeciton and storage in polypropylene syringes for pediatric use
Ling, J.; Gupta, V.D.
International Journal of Pharmaceutical Compounding 4(6): 480-481
2000
ISSN/ISBN: 1092-4221 PMID: 23981740 Document Number: 514484
The stability of nafcillin sodium (10 mg/mL) in 0.9% sodium chloride injection has been studied at 25 deg C and 5 deg C in polypropylene syringes by means of a stablilty-indicating high-performance liquid chromatograph assay method. The concentrations of the drug were directly related to peak heights and the percent relative standard deviation based on 5 injections was 1.2. The sodium citrate (added as a buffering agent in the powder) did not interfere with the assay procedure. The product(s) of decomposition separated from the intact drug. At 25 deg C, the loss in potency was less than 2% after 7 days of storage, and at 5 deg C it was also less than 2% when stored for 44 days. The pH values of the injections were between 6.2 to 7.0 throughout this study, except after 14 days of storage at room temperature (potency, 82.3%; pH,5.3). The drug did not adsorb to the syringes, and the physical appearance of the injection did not change. Nafcillin sodium was considered stable for at least 7 days at 25 deg C and 44 days at 5 deg C.