Chromic Phosphate P 32 Suspension
» Chromic Phosphate P 32 Suspension is a sterile, aqueous suspension of radioactive chromic phosphate P 32 in a 30 percent Dextrose solution suitable for intraperitoneal, intrapleural, or interstitial administration. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 32P as chromic phosphate expressed in megabecquerels (millicuries) per mL at the time indicated in the labeling. It may contain a preservative or a stabilizer. Other chemical forms of radioactivity do not exceed 5.0 percent 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 for Labeling under Injections 1: the time and date of calibration; the amount of 32P as labeled chromic phosphate expressed as total megabecquerels (millicuries) and concentration as megabecquerels (millicuries) per mL at 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 32P is 14.3 days.
Radionuclide identification—
A: The beta radiation of the Suspension, measured according to the procedure set forth under Radioactivity 821, 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 32P of known purity showing no distinct photopeaks and no energies greater than 1.710 MeV.
Bacterial endotoxins 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.
pH 791: between 3.0 and 5.0.
Radiochemical purity— Place a measured volume of Suspension, to provide a count rate of about 20,000 counts per minute, about 2.5 cm from one end of a 25-mm × 300-mm strip of chromatographic paper (see Chromatography 621), 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 under Injections 1, except that the Suspension may be distributed or dispensed prior to the completion of the test for Sterility, the latter test being started on the day of final manufacture, and except that it is not subject to the recommendations on Volume in Container.
Assay for dextrose—
Periodic acid reagent solution— Dissolve 8.5 g of sodium metaperiodate in 80 mL of 1 N sulfuric acid, dilute with water to 100 mL, and mix.
Assay preparation— Decant the supernatant from sterile Suspension into a disposable centrifuge tube, and centrifuge. Pipet 1.0 mL of the clear supernatant into a 25-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Pipet 50 mL of Periodic acid reagent solution into a 250-mL conical flask, add 3.0 mL of the Assay preparation, swirl, cover the flask, and allow to stand at room temperature for 2 hours. Add, in the order named and with rapid stirring, 50 mL of a saturated solution of sodium bicarbonate, 50.0 mL of 0.1 N potassium arsenite VS, 4 mL of potassium iodide solution (1 in 5), and 20 g of sodium bicarbonate. Stir the solution at room temperature for 15 minutes. Titrate with 0.1 N iodine VS, using 3 mL of starch TS as the indicator. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N iodine is equivalent to 1.802 mg of dextrose (C6H12O6). Not less than 27.0% and not more than 33.0% is found.
Assay for radioactivity— Using a suitable counting assembly (see Assay, Beta-emitting under Radioactivity 821), determine the radioactivity, in MBq (mCi) per mL, of Sterile Suspension by use of a calibrated system as directed under Radioactivity 821.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
(RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3299
Pharmacopeial Forum: Volume No. 27(6) Page 3323