Stability assessment of PET radiopharmaceuticals under extreme conditions: an ICH-compliant study on radiochemical and enantiomeric purity.

ABSTRACT:

Background

The stability testing of radiopharmaceuticals is a critical aspect of drug development and regulatory approval. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) provides comprehensive guidelines for stability testing, as outlined in the ICH Harmonised Tripartite Guideline Q1A(R2). In this study, the stability of o-(2-[¹⁸F]fluoroethyl)-L-tyrosine ([¹⁸F]FET) and methyl-[¹¹C]-L-methionine ([¹¹C]MET) was evaluated under GMP conditions to ensure their quality and safety. These radiopharmaceuticals are widely used in brain tumor imaging, yet their stability remains insufficiently studied. Given the short half-life of [¹¹C]MET (20 min), rapid pre

SUBMITTER: Forgacs V 

PROVIDER: S-EPMC12612456 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature