Radiopharmaceutical production system and quality control system utilizing high performance liquid chromatography

摘要

Apparatus for real-time automated quality control testing of radiopharmaceuticals, comprising a syringe pump (520) for introducing sample into the QC module, an endotoxicity sample vessel (521), an injection valve (516), a pH detector (513), a sample loop (517), an HPLC pump (503) for introducing mobile phase (509), a radiation detector (522) comprising two probes (542), a UV-light detector (502), an HPLC column (515) and a refractive index detector (505). One radiation probe (542) detects radioactivity of the sample before it passes through the HPLC column (515), the other detects the radioactivity of the separated sample. An associated method for automated quality control testing in real-time of radiopharmaceuticals is also disclosed, which also comprises the method steps of synthesising a radiopharmaceutical. When used as part of an integrated PET biomarker radiopharmaceutical production system, the present general inventive concept permits a manufacturer to produce product and conduct quality control tests with lower per dose costs.