Packaging and storage
Preserve in adequately shielded single-dose containers, at controlled room temperature.
Labeling
Label it to include the following, in addition to the information specified for
Labeling under
Injections 1: the time and date of calibration; the amount of
111In as labeled satumomab pendetide expressed as total megabecquerels (or millicuries) and concentration as megabecquerels (or millicuries) per mL at the time of calibration; the expiration date; and the statement, CautionRadioactive Material. The labeling indicates that, in making dosage calculations, correction is to be made for radioactive decay and also indicates that the radioactive half-life of
111In is 67.3 hours.
Bacterial endotoxins 85
It contains not more than 175/
V USP Endotoxin Units per mL of the Injection, when compared with USP Endotoxin RS, in which
V is the maximum recommended total dose, in mL, at the expiration date or time.
Radiochemical purity
Mix equal parts of Injection with 0.05 M diethylenetriamine pentaacetic acid in a clean glass vial. Apply a drop of this solution 1 cm from the bottom of a 1-cm × 8-cm instant thin-layer chromatographic silica gel strip. Allow the spot to air-dry, and develop the strip by ascending chromatography, using 0.9% sodium chloride solution as the solvent. Allow the solvent front to migrate 6 cm from the origin. Remove the strip from the solvent, and air-dry. Determine the distribution of radioactivity on the chromatogram by scanning with a suitable collimated radiochromatogram strip scanner, or cut the strip 1.6 cm from the bottom and determine the radioactivity of each piece in a suitable detector. Not less than 90% of the In-111 activity must be present as a band between RF = 0 and 0.1.