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1
: the time and date of calibration; the amount of 125I as iothalamate sodium expressed as total megabecquerels (microcuries or millicuries equivalent) 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 125I is 60 days.
85—
It contains 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 7.0 and 8.5.
821)—
Its gamma-ray spectrum is identical to that of a specimen of 125I of known purity that exhibits a major photoelectric peak having an energy of 0.035 MeV.
621), and allow to dry. Develop the chromatogram over a period of about 4 hours by ascending chromatography, using methanol and ammonium hydroxide (100:1.5) adjusted with 2 N sulfuric acid to a pH of 3 to 6, and air-dry. Determine the radioactivity distribution with a suitable collimated radiation detector. The radioactivity under the free radioiodide peak is not more than 2% of the total area of all peaks: not less than 98% of the total activity is found at the point of application (as iothalamate sodium).
1, except that it is not subject to the recommendation in Volume in Container.
821), determine the radioactivity, in kilobecquerels (or µCi) per mL, of the Injection by use of a calibrated system as directed under Radioactivity 821.