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 Labelingunder Injections á1ñ:the time and date of calibration;the amount of 99mTc as labeled bicisate expressed as total megabecquerels (or millicuries)per mLat 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 6.0hours.

USP Reference standards á11ñ— USP Endotoxin RS.

Bacterial endotoxins á85ñ— It contains not more than 175/VUSP Endotoxin Units per mL,in which Vis 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 5µLof Injection 2cm from the bottom of a 2.5-cm ×7.5-cm thin-layer chromatographic silica gel sheet.Allow the spot to dry for 5to 10minutes.Position the plate in a pre-equilibrated chromatographic chamber containing HPLCgrade ethyl acetate,and develop the chromatogram until the solvent front has moved 5cm from the origin (see Chromatography á621ñ).Remove the plate from the chamber,and allow to dry.Cut the chromatographic sheet 4.5cm 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 Pis the count from the top part of the plate,and Cis the count from the bottom part of the plate:not less than 90%of the total radioactivity is found as Tc99mbicisate.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 2µLof the Injection 1cm 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 0.5Mammonium acetate (60:40),develop to 7cm,remove the plate,and air-dry (see Chromatography á621ñ).Using a suitable calibrated scanner,determine the compounds present by calculating the retention factors for all peaks present.Compounds and approximate RFvalues are as follows:

Other requirements— It meets the requirements of the tests for Radionuclide identificationand Radionuclidic purityunder Sodium Pertechnetate Tc 99m Injection.It meets also the requirements for Injections á1ñ,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 á821ñ— 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:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1853

Phone Number:1-301-816-8305