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目的:探讨利用总有机碳分析仪检测药品包装材料中易氧化物方法的可行性。方法:选择蔗糖对照品作为标准易氧化物,根据不同浓度的蔗糖溶液消耗相应体积的硫代硫酸钠滴定液,建立标准曲线,从而制定一个适宜的易氧化物限度。结果:3批样品按化学滴定法和总有机碳检测法检查,均低于规定的限度。结论:总有机碳分析仪可以用于药品包装材料中易氧化物的检测,具备准确、方便的优点。
Objective: To explore the feasibility of using total organic carbon analyzer to test the method of easy oxide in pharmaceutical packaging materials. Methods: The sucrose reference substance was selected as the standard easy-to-oxidize substance. The corresponding volume of sodium thiosulfate solution was consumed according to different concentrations of sucrose solution, and a standard curve was established to establish a suitable limit of easy oxidation. Results: Three batches of samples were examined by chemical titration and total organic carbon test, both of which were below the prescribed limits. Conclusion: Total organic carbon analyzer can be used in the detection of easily oxidizable substances in pharmaceutical packaging materials, with the advantages of accuracy and convenience.