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

Identification— Mix 1g of Injectable Oil Suspension with 20mLof 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 Identificationtests under Propyliodone,and,after being dried at 105to constant weight,melts between 187and 190.

Weight per mL— Transfer 60to 70mLof well-shaken Injectable Oil Suspension to a 250-mLbeaker,place in a vacuum desiccator,and cautiously apply vacuum.When vigorous frothing has ceased,apply a pressure of about 10mm of mercury for 15minutes.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-mLpycnometer 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 mLis between 1.236g and 1.276g.

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

Other requirements— It meets the requirements under Injections á1ñ.

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

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1666

Phone Number:1-301-816-8305