Evaluation of alternative methods for radiochemical purity testing of indium-111 capromab pendetide.

To evaluate alternative methods for radiochemical purity testing of indium (In)-111 capromab pendetide after the discontinuation of instant thin-layer chromatography silica gel (ITLC-SG) strips. Descriptive experimental study. United States in 2009. Not applicable. Paper chromatography using Whatman 3MM strips, paper chromatography using Whatman 31ET strips, and mini-column chromatography using silica Sep-Pak cartridges were evaluated in the radiochemical purity testing of 13 consecutive vials of In-111 capromab pendetide prepared for clinical patient imaging procedures. These methods also were evaluated by testing seven aliquots of In-111 capromab pendetide that had been spiked with 5% to 15% In-111 pentetate (diethylene triamine pentaacetic acid). Correlation coefficients, radiochemical purity values for each method compared with ITLC-SG, and procedure times. Correlation coefficients of 0.988, 0.996, and 0.979 were found for ITLC-SG compared with Whatman 3MM, Whatman 31ET, and silica Sep-Pak, respectively. Compared with ITLC-SG, mean (±SD) radiochemical purity values differed by -0.8 ± 0.8 (range -2.5 to 0.4) for Whatman 3MM, -0.8 ± 0.6 (-2.3 to 0) for Whatman 31ET, and -0.5 ± 1.2 (-3.6 to 0.7) for silica Sep-Pak. The approximate time required to develop the chromatography strip or elute the mini-column was 3, 14, 5, and 6 minutes for ITLC-SG, Whatman 3MM, Whatman 31ET, and silica Sep-Pak, respectively. All three methods evaluated were acceptable alternatives to ITLC-SG for radiochemical purity testing of In-111 capromab pendetide. Based on its slightly higher correlation to ITLC-SG, slightly tighter SD and range, and slightly shorter development time, Whatman 31ET is preferred in our facility.

Citation

James A Ponto. Evaluation of alternative methods for radiochemical purity testing of indium-111 capromab pendetide. Journal of the American Pharmacists Association : JAPhA. 2011 May-Jun;51(3):359-62

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PMID: 21555286

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