Packaging and storage— Preserve in single-dose, light-resistant containers.

Identification— Mix 1 g of Injectable Oil Suspension with 20 mL of solvent hexane, filter the diluted suspension through a fine-porosity, sintered-glass crucible, and wash the residue free from peanut oil with the solvent hexane: the residue responds to the Identification tests under Propyliodone, and, after being dried at 105 to constant weight, melts between 187 and 190.

Weight per mL— Transfer 60 to 70 mL of well-shaken Injectable Oil Suspension to a 250-mL beaker, place in a vacuum desiccator, and cautiously apply vacuum. When vigorous frothing has ceased, apply a pressure of about 10 mm of mercury for 15 minutes. Remove the specimen, mix gently with a spatula without stirring in any air bubbles, adjust its temperature to about 20, and fill a clean, dry, tared 50-mL pycnometer with it. Adjust the temperature of the filled pycnometer to 25, remove any excess of the specimen, weigh, and calculate the net weight. The weight per mL is between 1.236 g and 1.276 g.

Iodine and iodide— Disperse 3.3 mL in 125 mL of alcohol-free chloroform, add 25 mL of sodium hydroxide solution (1 in 2500), and shake. Separate the aqueous layer, shake it with 125 mL of alcohol-free chloroform, and discard the chloroform. Proceed with 10 mL of the aqueous layer as directed in the test for Iodine and iodide under Propyliodone, beginning with “add 1 mL of 2 N nitric acid.”

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay— Open 1 container of Injectable Oil Suspension, stir the contents with a glass rod until mixed, replace the closure, and shake. Quickly transfer about 30 mg of Injectable Oil Suspension to a tared combustion capsule, and weigh accurately. Using this as the assay specimen, proceed as directed in the Assay under Iodoquinol. Each mL of 0.02 N sodium thiosulfate is equivalent to 0.7450 mg of C10H11I2NO3. From the weight of Injectable Oil Suspension taken and the observed Weight per mL, calculate the weight of propyliodone in each mL of Injectable Oil Suspension.

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 1851

Phone Number : 1-301-816-8305