Technetium Tc 99m Gluceptate Injection
D-glycero-D-gulo-Heptonic acid,technetium-99mTccomplex.
Technetium-99mTc D-glycero-D-gulo-heptonate complex. »Technetium Tc 99m Gluceptate Injection is a sterile,aqueous solution,suitable for intravenous administration,of sodium gluceptate and stannous chloride that is labeled with 99mTc.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 99mTc as stannous gluceptate complex expressed in megabecquerels (microcuries or millicuries)per mLat the time indicated in the labeling.It may contain antimicrobial agents and buffers.Other chemical forms of radioactivity do not exceed 10.0percent of the total radioactivity. Packaging and storage— Preserve in single-dose or in multiple-dose containers,at a temperature between 2and 8. 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 stannous gluceptate expressed as total megabecquerels (microcuries or millicuries)and concentration as megabecquerels (microcuries or millicuries)per mLat the time of calibration;the expiration date and time;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 The limit of endotoxin content is not more than 175/VUSP Endotoxin Unit per mLof the Injection,when compared with the USP Endotoxin RS,in which Vis the maximum recommended total dose,in mL,at the expiration date or time. pHá791ñ: between 4.0and 8.0. Radiochemical purity— Place a measured volume of Injection,appropriately diluted,such that it provides a count rate of about 20,000counts per minute,about 25mm from one end of a 25-×300-mm strip of chromatographic paper (see Chromatography á621ñ),and allow to air-dry.With no delay,develop the chromatogram over a suitable period of time by ascending chromatography,using acetone that has been purged with oxygen-free nitrogen for not less than 10minutes.Allow the chromatogram to dry,and determine the radioactivity distribution by scanning with a suitable collimated radiation detector.Not less than 90.0%of the total radioactivity is found as stannous gluceptate (at the point of application). Biological distribution— Constitute 1vial of Injection with 5mLto 10mLof Sodium Pertechnetate Tc 99m Injection.Inject intravenously 0.25mLof the resulting undiluted Injection into the caudal vein of each of three 150-to 250-g rats.Discard any injections in which extravasation occurs.Approximately 1hour after the injection,anesthetize the animals and exsanguinate,collecting the blood into a suitable container.Dissect the animals,and place the kidneys,liver,gastrointestinal tract,and a specimen of blood,accurately weighed,in separate,suitable counting containers,and determine the radioactivity,in counts per minute,in each container with an appropriate detector using the same counting geometry.Determine the percentage of radioactivity in the kidneys,liver,and gastrointestinal tract taken by the formula: 100Ai/A, in which Aiis the net radioactivity in the organ,and Ais the total radioactivity,in MBq (µCi),injected,both corrected to injection time.Determine the percentage of radioactivity in the blood taken by the formula: [100(B/WS)0.07(WR)]/A, in which Bis the net radioactivity in the specimen of blood,and Ais the total radioactivity,injected,both corrected to injection time,WSis the weight,in g,of the blood specimen,WRis the weight,in g,of the rat,and 0.07is the assumption that the total blood weight of the rat is 7%of the total body weight.Not less than 15.0%of the radioactivity is found in the kidneys,not more than 5.0%of the radioactivity is found in the blood,not more than 15.0%of the radioactivity is found in the entire gastrointestinal tract and not more than 5.0%of the radioactivity is found in the liver,in not fewer than 2of the rats. Other requirements— It meets the requirements for Radionuclide identificationand Radionuclidic purityunder Sodium Pertechnetate Tc 99m Injection.It meets also the requirements under Injections á1ñ,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,and except that it is not subject to the recommendation on Volume in Container. Assay for radioactivity á821ñ Using a suitable counting assembly (see Selection of a Counting Assembly),determine the radioactivity,in MBq (µCi)per mL,of Technetium Tc 99m Gluceptate Injection by use of a calibrated system. Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents USP28–NF23Page 1856 Phone Number:1-301-816-8305