Ferrous Gluconate Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Ferrous Gluconate Elixir)
»Ferrous Gluconate Oral Solution 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 Oral Solution in terms of the content of ferrous gluconate (C12H22FeO14·2H2O)and in terms of the content of elemental iron.
Identification— Avolume of Oral Solution diluted,where necessary,with water meets the requirements of 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 Oral Solution,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 immediately titrate 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).
(Official June 1,2005)
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