~(89)SrCl_2注射液的质量控制
Quality Control of ~(89)SrCl_2 Injection
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摘要: 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≤2 mg/L,含锶量≤12.5 g/L,细菌内毒素含量小于15 EU/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。Abstract: 89SrCl2 injection are prepared with neutron radiation reaction of 88Sr(n,γ)89Sr and asepsis technics, which radionuclide purity is not less than 99. 0%,radioconcentration is not less than 37 GBq/L, pH is in the range of 4. 0-7.5, aluminium content is not more than 2 mg/L and strontium content is not more than 12. 5 g/L,bacteria endotoxin content is less than 15 EU/mL and all the results of asepsis test are no growing up of bacteria. In corporation, the internal control standard of 89 SrCl2 injection is established according to quality status of 89SrCl2 injection.