Technetium Tc 99m Depreotide Injection, chemical structure, molecular formula, Reference Standards
Technetium Tc 99m Depreotide Injection
»Technetium Tc 99m Depreotide Injection is a sterile,aqueous solution suitable for intravenous injection that contains 99mTc in the form of a depreotide complex.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 99mTc as the depreotide complex expressed in megabecquerels (or in millicuries)per mLat the time indicated in the labeling.It may contain reducing agents,stabilizing agents,and buffers.It contains no antimicrobial agents.Other chemical forms of radioactivity do not exceed 10.0percent of the total radioactivity.
Packaging and storage
Preserve in single-dose containers,at controlled room temperature.
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 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 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.
between 6.0and 8.0.
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.
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.
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
Pharmacopeial Forum:Volume No.27(3)Page 2583
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