Packaging and storage— Preserve in single-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 depreotide complex expressed as total MBq (or mCi)per mLat the time of calibration;the expiration date and time;the storage temperature;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: not more than 175/VUSP Endotoxin Unit per mLof the Injection,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.

pHá791ñ: between 6.0and 8.0.

Radiochemical purity— Separately apply equal volumes (about 10µL)of Injection,accurately measured,about 1.0cm from the bottom of each of two 1.5-cm ×10-cm instant chromatographic silica gel strips.Do not allow the plates to dry.Immediately develop the chromatograms by ascending chromatography (see Chromatography á621ñ),until the solvents reach the top of the strips,using saturated sodium chloride solution as the developing solvent for one strip (Strip 1),and a mixture of methanol and 1Mammonium acetate (1:1)for the other strip (Strip 2).Remove the strips,and allow to air-dry.Cut Strip 1at an RFvalue of about 0.75,and cut Strip 2at an RFvalue of about 0.40.Separately record the counts for each portion in a dose calibrator.Calculate the percentage of nonmobile impurities in the portion of Injection taken by the formula: in which CMis the count obtained from the bottom portion of Strip 2;and PMis the count obtained from the top portion of Strip 2.Calculate the percentage of Tc 99m pertechnetate,Tc 99m glucoheptonate,and Tc 99m edetate in the portion of Injection taken by the formula: in which PSis the count obtained from the top portion of Strip 1;and CSis the count obtained from the bottom portion of Strip 1:not more than 10%of total impurities is found.

Other requirements— It meets the requirements for Radionuclide identificationand Radionuclidic purityunder Sodium Pertechnetate Tc 99m Injection.It also meets the requirements under Injections á1ñ,except that the Injection is not subject to the recommendation on Volume in Container,and except that it may be distributed or dispensed prior to completion of the test for Sterility,the latter test being started on the date of manufacture.

Assay for radioactivity á821ñ— Using a suitable counting assembly,determine the radioactivity,in MBq (or mCi)per mL,of Injection by use of a calibrated system.

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1853

Phone Number:1-301-816-8305