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;)
[65454-61-7].
and 8.
1
: the time and date of calibration; the amount of 99mTc as labeled pentetic acid complex expressed as total megabecquerels (millicuries or microcuries) and concentration as megabecquerels (microcuries or millicuries) per mL at the time of calibration; the expiration date; 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 6.0 hours.
85—
The limit of endotoxin content is not more than 175/V USP Endotoxin Unit per mL of the Injection, when compared with the USP Endotoxin RS, in which V is the maximum recommended total dose, in mL, at the expiration date or time.
791:
between 3.8 and 7.5.
726)—Soak a 2.5- × 17.0-cm cellulose polyacetate strip in 100 mL of Phosphate buffer for 10 to 60 minutes. Remove the strip with forceps, taking care to handle the outer edges only. Place the strip between two absorbent pads, and blot to remove excess solution. Attach the strip to the support bridge of an electrophoresis chamber containing Phosphate buffer in each side of the chamber. Ensure that each end of the strip is in contact with Phosphate buffer. Mark the application line near the cathode end of the strip. Apply as a spot 1 µL of a 1 in 1000 solution of amaranth in Phosphate buffer. Adjacent to this, apply as a narrow streak 5 µL of Injection having an activity of about 1 mCi per mL, previously diluted with saline TS, if necessary. Attach the chamber cover, and perform the electrophoresis at 300 volts until the amaranth (red dye) has moved about four-fifths of the length of the strip. Remove the strip from the chamber, and blot the ends on paper towels. Using a suitable scanner and counting assembly, determine the radioactivity distribution. Labeled technetium pentetate migrates a distance that is 0.9 relative to that of amaranth. Hydrolyzed technetium Tc 99m is located at the origin and pertechnetate migrates a distance that is 0.7 relative to that of amaranth: the sum of the percentages of radioactivity of hydrolyzed technetium Tc 99m and pertechnetate is not greater than 10.0% of the total radioactivity on the strip.
1, except that it may be distributed or dispensed prior to 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.
821—
Using a suitable counting assembly (see Selection of a Counting Assembly), determine the radioactivity, in MBq (µCi) per mL, of Injection by use of a calibrated system.