Edetate Disodium Injection
»Edetate Disodium Injection is a sterile solution of Edetate Disodium in Water for Injection,which,as a result of pHadjustment,contains varying amounts of the disodium and trisodium salts.It contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of C10H14N2Na2O8.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.
Identification— Transfer a volume of Injection,equivalent to about 1g of edetate disodium,to an evaporating dish,adjust with 3Nhydrochloric acid to a pHof 5.0,and evaporate on a steam bath to dryness:the residue responds to Identificationtests Aand Cunder Edetate Disodium.
Bacterial endotoxins á85ñ— It contains not more than 0.2USP Endotoxin Unit per mg of edetate disodium.
pHá791ñ: between 6.5and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Assay preparation— Dilute an accurately measured volume of Injection,equivalent to about 2g of edetate disodium,with water to volume in a 100-mLvolumetric flask,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Edetate Disodium,but use the formula:
335.9(W/V),
in calculating the weight of C10H14N2Na2O8.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 715
Phone Number:1-301-816-8251