Compatibility of [99mTc]Tc-EDDA/HYNIC-TOC and [68Ga] Ga-DOTA-TOC in a syringe for intravenous administration

Objective Drug quality in medical devices is not evaluated during the marketing authorization of radiopharmaceuticals. Therefore, the extemporaneous change of packaging made for preparation of patient unit doses in a syringe is the responsibility of radiopharmacists. The present study aimed to determine the impact of packaging and storage in a polypropylene syringe on the quality of hydrophilic drugs [99mTc]Tc-EDDA/HYNIC-TOC (Tektrotyd) and [68Ga]Ga-DOTA-TOC (Somakit-TOC). Methods Appearance, pH, radiochemical purity, sterility, and endotoxin tests were performed according the current European Pharmacopoeia. Subvisible and visible particles tests of the European Pharmacopoeia were adapted due to limited preparation volume (
Source: Nuclear Medicine Communications - Category: Nuclear Medicine Tags: Original Articles Source Type: research