Effect of Lyophilization on the Concentration and Recovery of Potential Leachables in Different Matrices Simulating Biological Media: Poster Presented at PDA Week 2025.

Abstract

Detecting migrant compounds from pharmaceutical packaging and medical devices is crucial for patient safety. Lyophilization, often used to enhance detection limits by removing water and concentrating analytes, may cause analyte losses. This study evaluated the impact of lyophilization on the recovery of antioxidants and UV stabilizers across different matrices. Solutions of six potential leachables-4-hydroxybenzophenone, Uvinul 3030 (UV stabilizers), Irganox 245, Irganox MD 1024, BHT, and Irganox 1010 (antioxidants)-were prepared in acetonitrile/water, saline, and a biological-like matrix. Recovery after lyophilization and reconstitution was quantified using HPLC-DAD, with T-tests (n = 6) comparing analyte retentions. Results showed that high-vapor-pressure antioxidants (e.g., BHT) suffered significant losses, while complex matrices improved retention. Biological-like media provided the highest retention (p < 0.01), exceeding saline and acetonitrile/water. Saline solutions resulted in more significant losses than biological-like media. These findings highlight that lyophilization may be unsuitable for salt-based solutions due to volatile analyte losses. The study illustrates the importance of considering analyte properties and matrix composition when optimizing sample preparation for detecting leachables in pharmaceutical and biological systems.