Etidronate Disodium Tablets
»Etidronate Disodium Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C2H6Na2O7P2.
Packaging and storage— Preserve in tight containers.
Identification,Infrared Absorption á197ñ— The spectra of trifluorovinyl chloride polymer and mineral oil dispersions,separately prepared from finely powdered Tablets recrystallized from water and dried at 105for 1hour,exhibit maxima in the regions of 4000to 1350cm-1and 1350to 450cm-1,respectively,only at the same wavelengths as those of similar preparations of USP Etidronate Disodium RS.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 30minutes.
Procedure— Determine the amount of C2H6Na2O7P2dissolved,employing the procedure set forth in the Assaymaking any necessary volumetric adjustments.
Tolerances— Not less than 70%(Q)of the labeled amount of C2H6Na2O7P2is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Titrant and Standard preparation—Prepare as directed in the Assayunder Etidronate Disodium.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 200mg of etidronate disodium,to a 100-mLvolumetric flask,and dilute with water to volume.Stir on a magnetic stirrer for about 10minutes,and filter.
Procedure— Proceed as directed for Procedurein the Assayunder Etidronate Disodium.Calculate the quantity,in mg,of C2H6Na2O7P2in the portion of Tablets taken by the formula:
200(VU/VS),
in which VUand VSare the volumes,in mL,of Titrantconsumed by the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 799
Pharmacopeial Forum:Volume No.30(5)Page 1619
Phone Number:1-301-816-8251