摘要
目的：探讨易氧化物检测法在葡萄糖注射液设备清洁验证中应用的可行性。方法：建立淋洗水法清洁葡萄糖注射液生产设备的清洁规程,采用0.02 mol/L高锰酸钾滴定液检测清洁验证样品中的易氧化物,并与总有机碳测定结果进行比对。结果：葡萄糖残留最低限度标准为10 mg/L;易氧化物检测法检测限为3 mg/L,在质量浓度5-30 mg/L范围内线性关系良好（r=0.999 5）;0.02 mol/L高锰酸钾滴定液消耗量不得大于0.35 ml,总有机碳最低限度标准为4 mg/L。批量生产后4次验证结果表明,各取样点最终淋洗水高锰酸钾滴定液消耗量均符合规定,总有机碳测定结果亦符合要求。结论：易氧化物检测法操作简便、成本低,可用于葡萄糖注射液设备的清洁验证,也可为其他含碳有机化合物生产设备的清洁验证提供参考。
OBJECTIVE： To investigate the feasibility of easy oxide detection method in equipment cleaning validation of Glu- cose injection. METHODS： The cleaning procedure of equipment for Glucose injection by rinse water method was established; potassium permanganate titration solution （0.02 mol/L） was used to detect easy oxide, and the results were compared with those of total organic carbon. RESULTS： The limits of residual glucose were 10 mg/L; the detection limit of easy oxide was 3 mg/L. The linear range were 5-30 mg/L （r=0.999 5）. The consumption amount of potassium permanganate titration solution （0.02 mo//L） would not be greater than 0.35 ml, and the limits of residual total organic carbon were 4 mg/L. The results of 4 times of validation tests showed that the amount of potassium permanganate in rinse water of sample sites were in line with the requirements, and the determination result of total organic carbon was concordant with the standard. CONCLUSIONS： The method of easy oxides determination is easy in operation, low in cost, and can be used for equipment cleaning validation of Glucose injection and provide reference for equipment cleaning validation of other organic compounds containing carbon.
出处
《中国药房》
CAS
北大核心
2016年第31期4463-4464,共2页
China Pharmacy
关键词
易氧化物
清洁验证
葡萄糖注射液
淋洗水法
Easy oxide
Cleaning validation
Glucose injection
Rinse water method
