Ferric Ammonium Citrate for Oral Solution, chemical structure, molecular formula, Reference Standards

Ferric Ammonium Citrate for Oral Solution

»Ferric Ammonium Citrate for Oral Solution contains Ferric Ammonium Citrate and an effervescent mixture of a suitable organic acid and an alkali metal bicarbonate.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of Fe.It may contain one or more suitable flavors,colors,or stabilizing agents.

Packaging and storage— Preserve in tight,light-resistant containers,and store in a cool place.

Identification— A6-g portion dissolves in 600mLof water with effervescence.The collected gas meets the requirements of the test for Bicarbonate á191ñ,and the resulting solution meets the requirements of the tests for Iron á191ñand for Citrate á191ñ.

Uniformity of dosage units á905ñ—

FOR POWDER PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume á698ñ—

FOR POWDER PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

Assay— Transfer about 6g of Ferric Ammonium Citrate for Oral Solution,accurately weighed,to a 250-mLconical flask,and dissolve in 100mLof water.Allow the gas to escape,add 5mLof hydrochloric acid and 4g of potassium iodide,insert the stopper,and allow to stand protected from light for 15minutes.Add 25mLof water,and titrate the liberated iodine with 0.1Nsodium thiosulfate VS,using starch TSas the indicator.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsodium thiosulfate is equivalent to 5.585mg of Fe.

Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 139

Pharmacopeial Forum:Volume No.29(6)Page 1845

Phone Number:1-301-816-8305