A Study of the Preparation of Disofenin and Gluceptate Cold-Unit Doses

摘要

This study evaluated the feasibility of preparing cold-unit doses (CUDs) of disofenin (DISIDA) and gluceptate (GHA) in syringe form. DISIDA and GHA reagent kits were reconstituted with normal saline and divided into single-unit doses (UDs) in accordance with the recommended volume of the manufacturers. These UDs were immediately frozen at -10?°C after preparation. After 5, 10, 12, 24, and 31 days of storage, 4 CUDs from the DISIDA group were randomly selected and radiolabeled with technetium-99m (99mTc) pertechnetate. The CUDs from the GHA group were similarly radiolabeled after 7, 16, 22, and 38 days of storage. Radiochemical impurities of these 99mTc-labeled CUDs were determined and analyzed. The DISIDA CUDs produced 99mTc-DISIDA CUDs with acceptable radiochemical purity (90%) for up to 31 days but the GHA CUDs produced acceptable 99mTc-GHA CUDs only up to 16 days.