Sodium Pertechnetate Tc 99m Injection, chemical structure, molecular formula, Reference Standards

Sodium Pertechnetate Tc 99m Injection

Pertechnetic acid (H99mTcO4),sodium salt.
Sodium pertechnetate (Na99mTcO4) [23288-60-0].

»Sodium Pertechnetate Tc 99m Injection is a sterile solution,suitable for intravenous or oral administration,containing radioactive technetium (99mTc)in the form of sodium pertechnetate and sufficient Sodium Chloride to make the solution isotonic.Technetium 99m is a radioactive nuclide formed by the radioactive decay of molybdenum 99.Molybdenum 99is a radioactive isotope of molybdenum and may be formed by the neutron bombardment of molybdenum 98or as a product of uranium fission.

Sodium Pertechnetate Tc 99m Injection contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 99mTc at the date and hour stated on the label.Other chemical forms of 99mTc do not exceed 5percent of the total radioactivity.

Packaging and storage— Preserve in single-dose or multiple-dose containers.

Labeling— If intended for intravenous use,label it with the information specified for Labelingunder Injections á1ñ.Label it also to include the following:the time and date of calibration;the amount of 99mTc as sodium pertechnetate expressed as total megabecquerels (millicuries)and as megabecquerels (millicuries)per mLon the date and at the time of calibration;a statement of the intended use,whether oral or intravenous;the expiration date;and the statement “Caution—Radioactive Material.”If the Injection has been prepared from molybdenum 99produced from uranium fission,the label so states.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.

Radionuclide identification(see Radioactivity á821ñ)— Its gamma-ray spectrum is identical to that of a specimen of 99mTc that exhibits a major photopeak having an energy of 0.140MeV.

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 4.5and 7.5.

Radiochemical purity— Place a 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).Develop the chromatogram over a suitable period of time by ascending chromatography,using a mixture of acetone and 2Nhydrochloric acid (80:20).Allow the chromatogram to air-dry.Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector.The radioactivity of the pertechnetate band is not less than 95%of the total radioactivity in the test specimen.The RFvalue for the pertechnetate band (approximately 0.9)falls within ±10.0%of the value found for a known sodium pertechnetate Tc 99m specimen when determined under identical conditions.

Radionuclidic purity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity of each radionuclidic impurity,in kBq per MBq (µCi per mCi)of technetium 99m,in the Injection by use of a calibrated system as directed under Radioactivity á821ñ.

For Injection prepared from technetium 99m derived from parent molybdenum 99formed as a result of neutron bombardment of stable molybdenum—

MOLYBDENUM99— The presence of molybdenum 99in the Injection is shown by its characteristic gamma-ray spectrum.The most prominent photopeaks of this radioactive nuclide have energies of 0.181,0.740,and 0.780MeV.Molybdenum 99decays with a radioactive half-life of 66.0hours.The amount of molybdenum 99is not greater than 0.15kBq per MBq (0.15µCi per mCi)of technetium 99m per administered dose in the Injection,at the time of administration.

OTHER GAMMA-EMITTING RADIONUCLIDIC IMPURITIES —The total amount of other gamma-emitting radionuclidic impurities does not exceed 0.5kBq per MBq (0.5µCi per mCi)of technetium 99m,and does not exceed 92kBq (2.5µCi)per administered dose of the Injection,at the time of administration.

For Injection prepared from technetium 99m derived from parent molybdenum 99formed as a result of uranium fission— Gamma-and beta-emitting impurities—

MOLYBDENUM99— The Injection meets the requirements set forth for the Injection prepared by neutron irradiation of stable molybdenum (see foregoing).

IODINE131— The most prominent photopeak of this radioactive nuclide has an energy of 0.364MeV.Iodine 131decays with a radioactive half-life of 8.08days.The concentration of iodine 131is not more than 0.05kBq per MBq (0.05µCi per mCi)of technetium 99m,at the time of administration.

RUTHENIUM103— The most prominent photopeak of this radioactive nuclide has an energy of 0.497MeV.Ruthenium 103decays with a radioactive half-life of 39.5days.The concentration of ruthenium 103is not more than 0.05kBq per MBq (0.05µCi per mCi)of technetium 99m,at the time of administration.

STRONTIUM89— Determine the presence of strontium 89in the Injection by a counting system appropriate for the detection of particulate radiations.Strontium 89decays by a beta emission with a maximum energy of 1.463MeV,and a radioactive half-life of 52.7days.Strontium 89may be present in a concentration of not more than 0.0006kBq per MBq (0.0006µCi per mCi)of technetium 99m,at the time of administration.

STRONTIUM90— Determine the presence of strontium 90in the Injection by a counting system appropriate for the detection of particulate radiations.Strontium 90decays by a beta emission with a maximum energy of 0.546MeV,and a radioactive half-life of 27.7years.Strontium 90may be present in a concentration of not more than 0.00006kBq per MBq (0.00006µCi per mCi)of technetium 99m,at the time of administration.

ALL OTHER RADIONUCLIDIC IMPURITIES— Not more than 0.01%of all other beta and gamma emitters is present at the time of administration.Not more than 0.001Bq of gross alpha impurity per 1MBq (or 0.001nCi of gross alpha impurity per 1mCi)of technetium 99m is present at the time of administration.

Chemical purity—

Aluminum (To be determined if separation is accomplished by an alumina column in the preparation of the Injection)—

ALUMINUM STANDARD SOLUTION —Dissolve 35.17mg,accurately weighed,of aluminum potassium sulfate dodecahydrate in water to make 1000.0mL.Each mLof this solution contains 2µg of Al.

PROCEDURE— Pipet 10mLof Aluminum standard solutioninto each of two 50-mLvolumetric flasks.To each flask add 3drops of methyl orange TSand 2drops of 6Nammonium hydroxide,then add 0.5Nhydrochloric acid,dropwise,until the solution turns red.To one flask add 25mLof sodium thioglycolate TS,and to the other flask add 1mLof edetate disodium TS.To each flask add 5mLof eriochrome cyanine TSand 5mLof acetate buffer TS,and add water to volume.Immediately determine the absorbance of the solution containing sodium thioglycolate TSat the wavelength of maximum absorbance at about 535nm,with a suitable spectrophotometer,using the solution containing the edetate disodium TSas a blank.Repeat the procedure using two 1.0-mLaliquots of Injection.Calculate the quantity,in µg per mL,of aluminum in the Injection taken by the formula:

20(TU/TS),

in which TUand TSare the absorbances of the solution from the Injection and the solution containing the aluminum standard,respectively.The concentration of aluminum ion in the Injection is not greater than 10µg per mL.

Methyl ethyl ketone (To be determined if separation is accomplished by liquid-liquid extraction in the preparation of the Injection)—Place 1.0mLof the Injection in a suitable container,and dilute with water to 20.0mL.Add 2.0mLof 1Nsodium hydroxide,mix,then add 2.0mLof 0.1Niodine,dropwise,and again mix.At the same time,prepare a standard by placing 1.0mLof a solution of methyl ethyl ketone (1in 1000)in a similar container and diluting with water to 20.0mL.Add 2.0mLof 1Nsodium hydroxide,mix,then add 2.0mLof 0.1Niodine,dropwise,and again mix.After 2minutes,the turbidity of the test specimen does not exceed that of the standard (0.1%).

Other requirements— It meets the requirements under 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,and except that it is not subject to the recommendation on Volume in Container.

Assay for radioactivity— Using a suitable counting assembly (see Selection of a Counting Assembly),determine the radioactivity,in MBq (mCi)per mL,in 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 1861

Phone Number:1-301-816-8305