Packaging and storage
Preserve in tight, light-resistant containers, and store in a cool place.
Identification
A 6-g portion dissolves in 600 mL of water with effervescence. The collected gas meets the requirements of the test for
Bicarbonate 191, and the resulting solution meets the requirements of the tests for
Iron 191 and for
Citrate 191.
Assay
Transfer about 6 g of Ferric Ammonium Citrate for Oral Solution, accurately weighed, to a 250-mL conical flask, and dissolve in 100 mL of water. Allow the gas to escape, add 5 mL of hydrochloric acid and 4 g of potassium iodide, insert the stopper, and allow to stand protected from light for 15 minutes. Add 25 mL of water, and titrate the liberated iodine with 0.1 N sodium thiosulfate VS, using
starch TS as the indicator. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N sodium thiosulfate is equivalent to 5.585 mg of Fe.
Auxiliary Information
Staff Liaison :
Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29NF24 Page 152
Pharmacopeial Forum : Volume No. 29(6) Page 1845
Phone Number : 1-301-816-8305