Chromic Phosphate P32Suspension
»Chromic Phosphate P32Suspension is a sterile,aqueous suspension of radioactive chromic phosphate P32in a 30percent Dextrose solution suitable for intraperitoneal,intrapleural,or interstitial administration.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 32Pas chromic phosphate expressed in megabecquerels (millicuries)per mLat the time indicated in the labeling.It may contain a preservative or a stabilizer.Other chemical forms of radioactivity do not exceed 5.0percent of the total radioactivity.
Packaging and storage— Preserve in single-dose or multiple-dose containers.
Labeling— Label it to include the following,in addition to the information specified forLabelingunderInjections á1ñ:the time and date of calibration;the amount of 32Pas labeled chromic phosphate expressed as total megabecquerels (millicuries)and concentration as megabecquerels (millicuries)per mLat the time of calibration;the expiration date;and the statements,“Caution—Radioactive Material,”and “For intracavitary use only.”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 32Pis 14.3days.
Radionuclide identification—
A: The beta radiation of the Suspension,measured according to the procedure set forth underRadioactivity á821ñ,shows a mass absorption coefficient within ±5%of the value found for a specimen of a known standard of the same radionuclide when determined under identical counting conditions and geometry.
B: Its beta-ray spectrum is identical to that of a specimen of 32Pof known purity showing no distinct photopeaks and no energies greater than 1.710MeV.
Bacterial endotoxins á85ñ— It contains not more than 175/VUSP Endotoxin Unit per mLof the Injection,when compared with the USP Endotoxin RS,in whichVis the maximum recommended total dose,in mL,at the expiration date or time.
pHá791ñ: between 3.0and 5.0.
Radiochemical purity— Place a measured volume of Suspension,to provide a count rate of about 20,000counts per minute,about 2.5cm from one end of a 25-mm ×300-mm strip of chromatographic paper (seeChromatography á621ñ),and allow to dry.Develop the chromatogram by ascending chromatography,using water as the solvent,and air-dry:the radioactivity in the chromic phosphate is not less than 95.0%of the total radioactivity when measured at the origin.
Other requirements— It meets the requirements underInjections á1ñ,except that the Suspension may be distributed or dispensed prior to the completion of the test forSterility,the latter test being started on the day of final manufacture,and except that it is not subject to the recommendations onVolume in Container.
Assay for dextrose—
Periodic acid reagent solution— Dissolve 8.5g of sodium metaperiodate in 80mLof 1Nsulfuric acid,dilute with water to 100mL,and mix.
Assay preparation— Decant the supernatant from sterile Suspension into a disposable centrifuge tube,and centrifuge.Pipet 1.0mLof the clear supernatant into a 25-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Pipet 50mLofPeriodic acid reagent solution into a 250-mLconical flask,add 3.0mLof theAssay preparation,swirl,cover the flask,and allow to stand at room temperature for 2hours.Add,in the order named and with rapid stirring,50mLof a saturated solution of sodium bicarbonate,50.0mLof 0.1Npotassium arsenite VS,4mLof potassium iodide solution (1in 5),and 20g of sodium bicarbonate.Stir the solution at room temperature for 15minutes.Titrate with 0.1Niodine VS,using 3mLof starch TSas the indicator.Perform a blank determination,and make any necessary correction.Each mLof 0.1Niodine is equivalent to 1.802mg of dextrose (C6H12O6).Not less than 27.0%and not more than 33.0%is found.
Assay for radioactivity— Using a suitable counting assembly (seeAssay,Beta-emitting underRadioactivity á821ñ),determine the radioactivity,in MBq (mCi)per mL,of Sterile Suspension by use of a calibrated system as directed underRadioactivity á821ñ.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1554
Pharmacopeial Forum:Volume No.27(6)Page 3323
Phone Number:1-301-816-8305