A Specific HPLC Method to Determine Residual HEPES in [⁶⁸Ga]Ga-Radiopharmaceuticals: Development and Validation.

ABSTRACT:

Background

Nowadays, in Nuclear Medicine, clinically applied radiopharmaceuticals must meet quality release criteria such as high radiochemical purity and radiochemical yield. Many radiopharmaceuticals do not have marketing authorization and have no dedicated monograph within European Pharmacopeia (Ph. Eur.); therefore, general monographs on quality controls (QCs) have to be applied for clinical application. These criteria require standardization and validation in labeling and preparation, including quality controls measurements, according to well defined standard operation procedures. However, QC measurements are often based on detection techniques that are specific to a certain chromatographic system. Several radiosyntheses of [⁶⁸Ga]Ga-radiopharmaceuticals are more eff

SUBMITTER: Migliari S 

PROVIDER: S-EPMC9323806 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature