Ferrous Gluconate Elixir, chemical structure, molecular formula, Reference Standards

Ferrous Gluconate Elixir

(Current title—not to change until June 1,2005)

Monograph title change—to become official June 1,2005

See Ferrous Gluconate Oral Solution

»Ferrous Gluconate Elixir contains not less than 94.0percent and not more than 106.0percent of the labeled amount of ferrous gluconate (C12H22FeO14·2H2O).

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

Labeling— Label the Elixir in terms of the content of ferrous gluconate (C12H22FeO14·2H2O)and in terms of the content of elemental iron.

USP Reference standards á11ñ— USP Potassium Gluconate RS.

Identification— Avolume of Elixir diluted,where necessary,with water responds to the Identificationtests under Ferrous Gluconate.

pHá791ñ: between 3.4and 3.8.

Alcohol content á611ñ: between 6.3%and 7.7%of C2H5OH.

Assay— Transfer an accurately measured volume of Elixir,equivalent to about 1.2g of ferrous gluconate,to a flask containing a cooled mixture of 80mLof recently boiled water and 80mLof 2Nsulfuric acid.Add orthophenanthroline TS,and titrate immediately with 0.1Nceric sulfate VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nceric sulfate is equivalent to 48.22mg of ferrous gluconate (C12H22FeO14·2H2O).

Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist

Expert Committee:(DSN)Dietary Supplements:Non-Botanicals

USP28–NF23Page 820

Pharmacopeial Forum:Volume No.28(2)Page 297

Phone Number:1-301-816-8389