Failure of Quality Control to Detect Errors in the Preparation of Technetium-99m Disofenin (DISIDA)

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Abstract
Uptake of 99mTc disofenin is so strongly hepatobiliary that striking appearance of radioactivity in the RES is almost certainly caused by improper preparation of the disofenin kit. Four patients who received injections of 99mTc disofenin demonstrated a pronounced RES biodistribution in addition to the expected hepatobiliary pattern. Since routine quality control testing had not forewarned about this gross lack of radiochemical purity, 99mTc disofenin kits were subjected to a variety of insults to elucidate the mechanisms of quality control failure. Assessment of radiochemical purity was conducted using instant TLC (ITLC) and 2 solvent systems. 99mTc pertechnetate and 99mTc sulfur colloid were injected into the cold disofenin kit. Visual inspections were not reliable for verifying the final radiopharmaceutical product because of dilution of the sulfur colloid by pertechnetate. ITLC testing failed because the assay method being used at that time did not accurately assess the hydrolyzed fraction (colloidal component). Recommendations are made to preclude recurrence of the errors that occurred.

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