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目的:建立地塞米松磷酸钠原料药细菌内毒素检查方法。方法:参照《中国药典》2010年版二部细菌内毒素检查法进行试验。结果:样品稀释至0.8 mg·ml~(-1)浓度,对鲎试剂与细菌内毒素的反应无干扰作用。其细菌内毒素限值定为1.25EU·mg~(-1)。结论:地塞米松磷酸钠原料药可用细菌内毒素检查法(凝胶法)控制其质量。
Objective: To establish a method for the detection of bacterial endotoxin of dexamethasone sodium phosphate raw material. Methods: According to the Chinese Pharmacopoeia 2010 edition two bacterial endotoxin test method for testing. Results: The sample was diluted to a concentration of 0.8 mg · ml ~ (-1) and did not interfere with the reaction of limulus agents to bacterial endotoxin. The bacterial endotoxin limit set at 1.25EU · mg ~ (-1). Conclusion: Dexamethasone sodium phosphate raw material can be used bacterial endotoxin test (gel method) to control its quality.