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Title: Rapid miniaturized chromatography procedures for iodinated monoclonal antibodies: comparison to gel exclusion chromatography

Journal Article · · J. Nucl. Med. Technol.; (United States)
OSTI ID:5952645

Chromatographic quality control testing of radioiodinated monoclonal antibodies (/sup 131/I MOAB) is necessary to assess radiochemical purity prior to patient injection. Conventional gel exclusion chromatography column scanning (GCS) is time consuming and not practical. The authors investigated rapid miniaturized chromatographic procedures for evaluating the radiochemical purity of /sup 131/I MOAB. Three systems were evaluated using Gelman ITLC-SG and three solvents: acetone, 85% methanol, and 0.9% NaCl. Radiochemical analysis was performed on Na/sup 131/I of high radiochemical purity and Na/sup 131/I containing radiochemical impurities, as well as three /sup 131/I MOAB preparations. Five separate measurements were obtained for each preparation and solvent, and the results were compared to GCS. The results demonstrated ITLC-SG and 0.9% NaCl was most accurate in assessing radiochemical purity when compared to GCS. With the ITLC-SG and acetone system, and to a lesser degree, the ITLC-SG and 85% methanol system, no separation between /sup 131/I iodate/periodate and /sup 131/I MOAB was achieved, resulting in some instances in the overestimation of the radiochemical purity of the /sup 131/I MOAB.

Research Organization:
Northwestern Memorial Hospital, Chicago, IL
OSTI ID:
5952645
Journal Information:
J. Nucl. Med. Technol.; (United States), Vol. 15:3
Country of Publication:
United States
Language:
English