Development and validation of a headspace gas chromatographic method for the determination of residual solvents in [18F]FDG

Velickovska, Maja and Jolevski, Filip and Atanasova, Marija and Cocevska, Maja and Kolevska, Katerina and Ugrinska, Ana and Janevik-Ivanovska, Emilija (2024) Development and validation of a headspace gas chromatographic method for the determination of residual solvents in [18F]FDG. In: 11th Balkan Congress of Nuclear Medicine, 30 May - 02 Jun 2024, Skopje, North Macedonia. (Unpublished)

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Abstract

[18F]FDG is the most widely used radiopharmaceutical for molecular imaging by positron emission tomography (PET). Fludeoxyglucose [18F] injection is a sterile solution of fluorine-18 in the form of 2-deoxy-2-[18F]fluoro-α-D-glucopyranose, intended for intravenous administration. The quality control of [18F]FDG produced at University Institute of Positron Emission Tomography is in accordance with quality requirements of EP monograph 01/2014:1325. Residual solvents is one of the post-release parameters applied on every produced batch. Considering the synthesis of [18F]FDG injection, ethanol and acetonitrile occur as residual solvents. According to EP general chapter 5.4., ethanol is placed into Class 3 solvents with recommended concentration limit 5000 ppm, and acetonitrile is placed into Class 2 solvents with recommended concentration limit 410 ppm.
Headspace gas chromatographic method was developed and validated for the determination of ethanol and acetonitrile. Shimadzu gas chromatographic system GC-2010 plus was used, equipped with FID and head space injector HS-20. The method involved use of DB-624 column (30 m x 0,53 mm, 3µm) with split injection, temperature gradient elution with helium as carrier gas. Method validation was done by evaluating parameters as selectivity, linearity and range, detection limit, quantitation limit, precision and accuracy. The range of the method was evaluated from the Quantitation limit to the maximum allowed limit showing suitable accuracy and precision, and correlation coefficient above 0,99 for both, ethanol and acetonitrile.
This method was successfully applied for the quantitative determination of ethanol and acetonitrile in [18F]FDG injection as a simple and reliable solution for routine analyses.

Item Type:	Conference or Workshop Item (Poster)
Subjects:	Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Maja Cocevska
Date Deposited:	01 Jul 2024 07:27
Last Modified:	01 Jul 2024 07:27
URI:	https://eprints.ugd.edu.mk/id/eprint/34357

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