Work

Development and Validation of an HPLC Method to Determine Chemical and Radiochemical Purity of [18F]Florbetazine Injection

Year: 2025

Type: article

Abstract: ABSTRACT [18F]Florbetazine injection, a radiotracer that could target Aβ plaques and achieve diagnosis of Alzheimer's disease (AD), is a novel positron emission tomography (PET) imaging agent currently in the investigational new drug (IND) application stage. The active ingredient of [18F]Florbetazine injection, [18F]Florbetazine, is a diaryl‐azine derivative. Chemical and radiochemical purity is critical quality attributes (CQAs) for [18F]Florbetazine injection, and thus, we have developed and validated a relevant HPLC method. This study describes the specificity, linearity, accuracy, repeatability, and limit of quantification (LOQ) of the HPLC method. The stability of three sample batches was investigated using the established method. The validation results demonstrated the accuracy, precision, and sensitivity of the method, making it suitable for implementation as part of the quality control (QC) process for [18F]Florbetazine injection. The stability of three sample batches revealed a decrease in concentration and radiochemical purity over 10 h. However, all samples maintained a radiochemical purity of over 90% after 10 h. The results provided a foundation for establishing quality standards for [18F]Florbetazine injection. The same methodology employed in this study could be applied and modified for QC protocols of other 18F‐labeled radiopharmaceuticals.

Source: Journal of Labelled Compounds and Radiopharmaceuticals

DOI: 10.1002/jlcr.4140

Authors: Fuhai Wu, Xiaoming Wang, Huan Chen, Xu Zhou, Hailong Zhao, Mengchao Cui

Institutions: Beijing University of Technology, China Science and Technology Publishing & Media, Beijing Normal University

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: bronze

Funders: Beijing Municipal Science and Technology Commission, State Administration for Science, Technology and Industry for National Defense