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, “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 6.0 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.
Radiochemical purity—
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. [NOTE—The 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.
;)
