Abstract:
OBJECTIVE To observe the effects of excipient on the sterile stability of Ioxilan Injection. METHODSThe pH values,free iodide,chromatographic purity and the contents of Ioxilan Injection were measured. The change were calculated before and after sterilization at 120 ℃.RESULTSThe results showed that the injection containing tris(hydroxymethyl) aminomethane 1.0 mg·mL-1 and EDTA disodium calcium 0.1 mg·mL-1 is the stablest. CONCLUSIONIoxilan Injection should contain tris(hydroxymethyl) aminomethane1.0 mg·mL-1 and EDTA disodium calcium 0.1 mg·mL-1.