Validation of 5 analytical methods (pH, peptide concentration, loss on drying radiochemical purity, peptide identity and purity) for quality control of the kits used for Ga-68 radiolabeling

Kits are gaining popularity as a known convenient labelling procedure for gallium-68 based radiopharmaceuticals in the Nuclear Medicine clinic. Cold kits are a benefit to small radiopharmaceutical sites, but their quality should be checked in the same way as if they were produced by big pharmaceutical producers. Set of data from different validated methods (pH, concentration, radiochemical purity, identity and loss on drying) are presented. Methods are validated according to European Pharmacopoeia and such are used for quality control of radiopharmaceutical kits.

套件作为一种已知便捷的标签程序，在核医学领域针对镓-68类放射性药物日益受到青睐。对于小型放射性药物机构而言，冷套件具有显著优势，但其质量检验应与大型制药生产商生产的套件相同。本文展示了来自不同验证方法（pH值、浓度、放射性化学纯度、身份鉴定和干燥失重）的数据集。这些方法根据欧洲药典进行验证，并用于放射性药物套件的质量控制。