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.
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.
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:
100CM/(CM+PM),
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:
100PS/(CS+PS),
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.