TABLE 1

Quality Control of 99mTc-Rituximab for Clinical Application

ParameterQC specificationQC result
AppearanceClear, colorlessPass
Volume0.5–1.0 mL0.5 mL
Injection dose18.5–37 MBq37 MBq
pH4.0–8.07.0
Radio–thin-layer chromatography>95%>99%
Radio–high-performance liquid chromatography>95%>99%
Ethanol<5%0
Endotoxins<15 EU/mLPass
SterilitySterilePass
Specific activity111 GBq/μmolPass