摘要 |
PROBLEM TO BE SOLVED: To provide radiolabeling compositions with ease of use as an "instant" kit involving a single lyophilized vial and a liquid diluent vial, having high radiochemical purity upon radiolabeling, for preparation of a cancer detection agent for use in sentinel lymph node biopsy for melanoma and breast cancer diagnosis.SOLUTION: There is provided a composition comprising the following (a) to (f) for radiolabeling, with technetium-99, a dextran conjugated with diethylenetriaminepentaacetic acid (DTPA) as a chelating agent: (a) a DTPA-dextran with a concentration less than or equal to 0.50 mg/vial ; (b) a non-reducing disaccharide with a concentration less than or equal to 2% (w/v); (c) a non-sulfhydryl antioxidant with a concentration of about 0.5 mg/vial; (d) a stannous salt in which the concentration of the dihydrate form of the stannous salt is less than or equal to 75 μg/vial; (e) a pH buffer with a concentration less than or equal to about 0.5 mg/vial; and (f) a water for injection (WFI) degassed and deaerated with an inert gas. |