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同位素  2003 

~(89)SrCl_2注射液的质量控制

, PP. 194-194

Keywords: 骨肿瘤治疗,89SrCl2注射液,质量控制

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Abstract:

对本公司研制的89SrCl2注射液的质量进行了分析,结果表明88Sr通过中子辐照反应88Sr(n,γ)89Sr及相关无菌工艺制得的89SrCl2注射液的放射性核纯度不低于99.0%,放射性浓度不低于37GBq/L,pH为4.0~7.5,含铝量≤2mg/L,含锶量≤12.5g/L,细菌内毒素含量小于15EU/mL,无菌检验结果均无细菌生长。根据试生产89SrCl2注射液的质量情况,制定了内控质量标准。

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