Improved quality control of [¹⁷⁷Lu]Lu-PSMA I&T.

ABSTRACT:

Background

Targeted radionuclide therapy with [¹⁷⁷Lu]Lu-PSMA I&T (zadavotide guraxetan) has proven high efficacy and safety in treating patients with advanced prostate cancer worldwide. Several methods to determine the radiochemical purity have been reported but also limitations in the HPLC analysis due to retention of the sample and tailing effects when using standard gradients containing trifluoroacetic acid (TFA). We here report on the validation of a method for quality control of [¹⁷⁷Lu]Lu-PSMA I&T including determination of radiochemical purity, identity testing and limit test for PSMA I&T by HPLC using a Phosphate buffer /Acetonitrile gradient system, complemented with a TLC system with 0.1N Citrate buffer pH 5 as mobile phase including validation of the

SUBMITTER: Kraihammer M 

PROVIDER: S-EPMC10043144 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature