Packaging and storage— Preserve in single-dose or multiple-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 99mTc as labeled bicisate expressed as total megabecquerels (or millicuries) per mL at the time of calibration; the expiration date and time; the lot number; and the statement “Caution—Radioactive 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 99mTc is 6.0 hours.

USP Reference standards 11— USP Endotoxin RS.

Bacterial endotoxins 85— It contains not more than 175/V USP Endotoxin Units per mL, in which V is the maximum recommended total dose, in mL, at the expiration date or time.

Radiochemical purity— Prepare four vials of Injection and perform the test on each vial. Apply about 5 µL of Injection 2 cm from the bottom of a 2.5-cm × 7.5-cm thin-layer chromatographic silica gel sheet. Allow the spot to dry for 5 to 10 minutes. Position the plate in a pre-equilibrated chromatographic chamber containing HPLC grade ethyl acetate, and develop the chromatogram until the solvent front has moved 5 cm from the origin (see Chromatography 621). Remove the plate from the chamber, and allow to dry. Cut the chromatographic sheet 4.5 cm from the bottom. Separately count the activity on each piece in a dose calibrator or a gamma counter. The activity on the upper portion contains the 99mTc bicisate complex, and the activity on the lower section contains all radioimpurities. Calculate the percentage of radiochemical purity of the 99mTc Bicisate Injection by the formula: in which P is the count from the top part of the plate, and C is the count from the bottom part of the plate: not less than 90% of the total radioactivity is found as Tc99m bicisate. Calculate the mean percent radiochemical purity of the four test vials.

Related radiochemical compounds— [NOTE—This test is performed on the same test specimen used to perform the Radiochemical purity test. Perform the tests in parallel with a minimal delay in spotting of the chromatographic media following the 30-minute Injection incubation period.] Apply about 2 µL of the Injection 1 cm from the bottom of a 2.5-cm × 7.5-cm reverse-phase thin-layer chromatographic plate (or equivalent), and allow the spot to air-dry thoroughly. Place the plate into a developing tank containing a mixture of acetone and 0.5 M ammonium acetate (60:40), develop to 7 cm, remove the plate, and air-dry (see Chromatography 621). Using a suitable calibrated scanner, determine the compounds present by calculating the retention factors for all peaks present. Compounds and approximate RF values are as follows:

Other requirements— It meets the requirements of the tests for Radionuclide identification and Radionuclidic purity under Sodium Pertechnetate Tc 99m Injection. It meets also the requirements for Injections 1, except that the Injection may be distributed or dispensed prior to the completion of the test for Sterility, the latter test being started on the day of manufacture.

Assay for radioactivity 821— Using a suitable counting assembly (see Selection of a Counting Assembly), determine the radioactivity, in Mbq (or in mCi) per mL, of the Injection by use of a calibrated system.

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 2063

Phone Number : 1-301-816-8305