摘要
建立了来昔决南钐[153Sm]注射液的质量控制指标及方法,主要包括pH检查、细菌内毒素检查、无菌检查、性状鉴别、含游离依地四膦酸量、来昔决南钐含量、放射性核纯度、放化纯度、放射性浓度。分析方法适用于来昔决南钐[153Sm]注射液的常规检验,为该药的质量控制提供了可靠的分析手段。
The quality control indices and analysis methods for Samarium Sm-153 Lexidronam Injection were established including radionuclide purity, sterility test, bacterial endotoxin, radionuclide identification , radiochemical purity, EDTMP, samarium , pH, radioactive. The solution is applicable for the routine inspection of Samarium Sm 153 Lexidronam Injection, It provides a reliable analysis method for the drug quality control.
出处
《同位素》
CAS
2015年第3期140-147,共8页
Journal of Isotopes
