3PC-022 Optimisation of quality controlfor 68Ga-edotreotide (SomaKit): time is of the essence..
Year: 2025
Type: conference-paper
Abstract: Background and Importance Edotreotide (SomaKit), radiolabelled with 68Ga, is used in PET imaging to study somatostatin receptor overexpression. Quality control (QC), as outlined in the product summary (SmPC), includes determining radiochemical purity (RCP) via a two-system radiochromatographic method. The eluent migration step is the most time-consuming in this process. Aim and Objectives This study aimed to optimise the radiochromatographic method by reducing the migration distance (Dm) while maintaining acceptable analytical performance. Material and Methods Ten trials were conducted, each with two radiochromatographic systems: System 1: ITLC-SG stationary phase and 77g/L ammonium acetate in a 50:50 water/methanol mobile phase. System 2: ITLC-SG stationary phase and 0.1 mol/L sodium citrate in water mobile phase. Each trial used four chromatography strips: two following the SmPC (12 cm strips with 9 cm Dm) and two with an alternative method (4 cm strips with 3 cm Dm). Migration times (Tm) were recorded, and radiochromatograms were analysed with Gina software for RCP and resolution (Rs). Results were expressed as mean ± standard deviation, and a significance level of α = 0.05 was used to compare RCP means. All chromatograms required Rs > 1.5 (EANM standard). Results For System 1, the average migration times were 22.67 ± 1.53 minutes for a 9 cm Dm and 2.67 ± 0.29 minutes for a 4 cm Dm. For System 2, the average migration times were 7.08 ± 0.80 minutes for a 9 cm Dm and 1.50 ± 0.50 minutes for a 4 cm Dm. The average RCP was 98.39 ± 1.16% for a 9 cm Dm and 97.98 ± 1.65% for a 4 cm Dm. There was no significant difference in RCP between the two Dm values (p = 0.7). All radiochromatograms showed an acceptable resolution (Rs > 1.5). On average, the optimised method with a reduced Dm of 4 cm resulted in a time saving of approximately 20 minutes. Conclusion and Relevance Reducing the migration distance significantly reduced QC time while maintaining satisfactory analytical characteristics (Rs > 1.5) and comparable RCP to the reference method (p ≥ 0.05). This time saving, taking into account the radioactive half-life of 68Ga (67.8 minutes), allowed us to increase the average number of doses dispensed per preparation. References and/or Acknowledgements Conflict of Interest No conflict of interest
Institution: Hospices Civils de Lyon
Language: English
Subfield: Radiology, Nuclear Medicine and Imaging
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408376641