Moxalactam disodium compatibility with intramuscular and intravenous diluents.
The stability of moxalactam disodium with mannitol injection in combination with intramuscular and intravenous diluents was investigated. Solutions were stored in original glass containers stoppered with butyl rubber closures or in polyvinyl chloride bags. Five diluents were evaluated at an intramuscular concentration of moxalactam 1 g (as the disodium salt) in 3 ml of diluent. Twenty intravenous diluents were evaluated with moxalactam 1 g (as the disodium salt) in 50 or 500 ml of diluent. High-performance liquid chromatography, polarography, thin-layer chromatography, spectrophotometric color evaluations, nephelometry, and pH determinations were performed. Solutions were assayed initially after reconstitution and stored for subsequent assay at refrigerator (5 degrees C) and room (25 degrees C) temperatures. The moxalactam disodium solutions were stable for up to 96 hours when stored at 5 degrees C or 24 hours when stored at 25 degrees C. The color, clarity, and TLC data were satisfactory for all diluent combinations tested. Polarographic, HPLC, and TLC data showed that the degradation products remained within acceptable limits when stored for 96 hours at 5 degrees C or 24 hours at 25 degrees C. The slight pH changes were within regulatory limits for moxalactam. The moxalactam disodium solutions maintained at least 90% of initial potency for up to 96 hours when stored in a refrigerator. If kept at room temperature, the reconstituted solutions should be used within 24 hours.
D002511:Cephalosporins; D002513:Cephamycins / Q000008:administration & dosage; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D003116:Color; D004344:Drug Incompatibility; D005079:Excipients; D006863:Hydrogen-Ion Concentration; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D009070:Moxalactam; D011048:Polarography
D002511:Cephalosporins; D002513:Cephamycins; D005079:Excipients; D009070:Moxalactam