来昔决南钐<sup>153</sup>Sm注射液质量控制标准

来昔决南钐¹⁵³Sm注射液质量控制标准

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。

Abstract: 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.