Technetium Tc 99m Mertiatide Injection
Technetate(2-)-99mTc,[N-[N-[N-(mercaptoacetyl)-glycyl]glycyl]glycinato(5-)-N,N¢,N¢¢,S]-oxo-, disodium, (SP-5-25)-.
Disodium [N-[N-[N-(mercaptoacetyl)glycyl]glycyl]glycinato(5-)-N,N¢,N¢¢,S]-oxo[99mTc]technetate(V) [125224-05-7].
» Technetium Tc 99m Mertiatide Injection is a sterile aqueous solution, suitable for intravenous injection, that contains 99mTc in the form of a chelate of mertiatide. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 99mTc as mertiatide complex expressed in megabecquerels (or in microcuries or millicuries) per mL at the date and time indicated in the labeling. It contains uncomplexed betiatide, a suitable 99mTc reducing agent, a transfer ligand, and stabilizers.
Packaging and storage Preserve in single-dose or multiple-dose containers.
Labeling Label it to include the following, in addition to the information specified for Labeling under Injections 1: the time and date of calibration; the amount of 99mTc as labeled mertiatide expressed as total megabecquerels (or millicuries) and the concentration as megabecquerels per mL (or as millicuries per mL) on the date and time of calibration; the expiration date and time; and a 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 6.0 hours.
Bacterial endotoxins 85 It contains not more than 175/V USP Endotoxin Unit per mL, in which V is the maximum recommended total dose, in mL, at the expiration date or time.
pH791: between 5.0 and 6.0.
Method 1 (Determination of hydrolyzed reduced technetium)Apply about 5 to 10 µL (100 to 250 µCi) 15 mm from the bottom of a 25-mm × 20-cm strip of chromatographic paper (see Chromatography 621). Immediately develop the chromatogram by ascending chromatography using a solvent system consisting of a mixture of acetonitrile and water (60:40) until the solvent front has moved about 13 cm from the origin. Remove the strip, and allow to dry. Determine the radioactivity distribution by scanning the chromatogram using a suitable collimated radiation detector. Calculate the percentage of hydrolyzed reduced technetium by the formula:
100(Aht / Bs)in which Aht is the sum of all the peaks at or near the origin, where RF is less than 0.25, and Bs is the sum of all of the peaks: not more than 2.0% of hydrolyzed reduced technetium is found.
Method 2 (Simultaneous determination of free pertechnetate and 99mTc mertiatide)
solution a Prepare a filtered and degassed solution of monobasic potassium phosphate in water to obtain a solution containing 1.36 mg per mL. To each L of this solution, add 1.0 mL of triethylamine, and adjust with 1.0 N hydrochloric acid to a pH of between 4.9 and 5.1. Make adjustments if necessary (see System Suitability under Chromatography 621).
solution b Prepare a filtered and degassed solution of monobasic potassium phosphate in 900 mL of water, and add 100 mL of tetrahydrofuran to obtain a solution containing 1.36 mg per mL. To each L of this solution, add 1.0 mL of triethylamine, and adjust with 1.0 N hydrochloric acid to a pH of between 4.9 and 5.1. Make adjustments if necessary (see System Suitability under Chromatography 621).
mobile phase Mix specified portions of freshly prepared and degassed Solution A and Solution B.
test solution Immediately before testing, dilute a portion of the Injection with Water for Injection to obtain a concentration of between 400 to 600 µCi. [noteThe extent to which the sample is diluted is determined by the sensitivity of the radiometric detector.]
chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 3.9-mm × 15-cm column that contains packing L1 and a flow-through gamma-ray detector and is programmed to provide a Mobile phase consisting of variable mixtures of Solution A and Solution B. The system is equilibrated for 15 minutes with a Mobile phase consisting of a mixture of 90% Solution A and 10% Solution B. After injecting the Test solution, change the composition of the Mobile phase linearly over the next 30 minutes so that the final Mobile phase composition consists of 20% Solution A and 80% Solution B. Hold with this composition for 5 minutes and then change in reverse to a composition of 90% Solution A and 10% Solution B over a 5-minute period. The flow rate is about 1 mL per minute.
procedure Inject about 20 µL of the Test solution into the chromatograph, record the chromatograms by gradient elution (see the Chromatographic system). The retention time is between 1.8 and 2.2 minutes for 99mTc pertechnetate and between 10 and 14 minutes for 99mTc mertiatide. Calculate the percentage of 99mTc pertechnetate by the formula:
100(rpt / rs)in which rpt is the peak response of 99mTc pertechnetate, and rs is the sum of all peak responses: not more than 6.0% of 99mTc pertechnetate is found.
Calculate the percentage of 99mTc mertiatide by the formula:
100(rmt / rs¢)
in which rmt is the peak response of 99mTc mertiatide, and rs¢ is the sum of all peak responses: not less than 90.0% of 99mTc mertiatide is found.
Other requirements It meets the requirements of the tests for Radionuclide identification and Radionuclidic purity under Sodium Pertechnetate Tc 99m Injection. It also meets the requirement under Injections 1, except that it may be distributed or dispensed prior to completion of the test for Sterility 71, the latter test being started on the day of final manufacture, and except that it is not subject to the recommendation on Volume in Container.
Assay for radioactivity 821 Using a suitable counting assembly, determine the radioactivity, in Mbq (or millicuries) per mL, of the Injection by use of a calibrated system.
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USP32NF27 Page 3666