Ferrous Fumarate Tablets
»Ferrous Fumarate Tablets contain not less than 95.0percent and not more than 110.0percent of the labeled amount of ferrous fumarate (C4H2FeO4).
Packaging and storage— Preserve in tight containers.
Labeling— Label the Tablets in terms of ferrous fumarate (C4H2FeO4)and in terms of elemental iron.
Identification— To a portion of powdered Tablets,equivalent to 1g of ferrous fumarate,add 25mLof dilute hydrochloric acid (1in 2),mix,and add 25mLof water.Boil the solution for a few minutes,cool,and filter:the filtrate responds to the tests for Iron á191ñ.
Dissolution á711ñ—
Medium: 0.1Nhydrochloric acid in 0.5%sodium lauryl sulfate;900mL.
Apparatus 2: 75rpm.
Time: 45minutes.
Procedure— Determine the amount of C4H2FeO4dissolved,employing atomic absorption spectrophotometry at a wavelength of about 248.3nm on filtered portions of the solution under test,suitably diluted with Dissolution Mediumif necessary,in comparison with a Standard solution having a known concentration of iron in the same Medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C4H2FeO4is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 500mg of ferrous fumarate,to a 250-mLbeaker.Add 25mLof water,25mLof nitric acid,and 7.5mLof perchloric acid.Cover with a ribbed watch glass,and heat to the production of strong fumes.Cool,rinse the watch glass and the sides of the beaker with water,and evaporate in a hood to near-dryness.Wash down the watch glass and the sides of the beaker with 2mLof hydrochloric acid and then with a small volume of water.Warm slightly,if necessary,to dissolve the residue.Transfer to a glass-stoppered,250-mLconical flask.Repeat the washing with 2mLof hydrochloric acid,and complete the transfer to the flask,using not more than 20to 25mLof water for the transfer.Add 4g of potassium iodide to the flask,insert the stopper,and allow to stand in the dark for 5minutes.Add 75mLof water,and titrate with 0.1Nsodium thiosulfate VS,adding 3mLof starch TSas the endpoint is approached.Each mLof 0.1Nsodium thiosulfate is equivalent to 16.99mg of ferrous fumarate (C4H2FeO4).
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 817
Phone Number:1-301-816-8389