Edetate Calcium Disodium Injection
»Edetate Calcium Disodium Injection is a sterile solution of Edetate Calcium Disodium in Water for Injection.It contains,in each mL,not less than 180mg and not more than 220mg of C10H12CaN2Na2O8.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.
Identification—
A: Transfer a volume of Injection,equivalent to about 1g of edetate calcium disodium,to an evaporating dish,and evaporate on a steam bath to dryness:the residue responds to Identificationtest Aunder Edetate Calcium Disodium.
B: It responds to Identificationtest Bunder Edetate Calcium Disodium.
Bacterial endotoxins á85ñ— It contains not more than 0.01USP Endotoxin Unit per mg of edetate calcium disodium.
pHá791ñ: between 6.5and 8.0.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Dilute an accurately measured volume of Injection,equivalent to about 1g of edetate calcium disodium with water to about 75mL.Add 25mLof 1Nacetic acid and 1mLof diphenylcarbazone TS,mix,and titrate slowly with 0.1Mmercuric nitrate VSto the appearance of the first purplish color.Perform a blank determination,and make any necessary correction.Each mLof 0.1Mmercuric nitrate is equivalent to 37.43mg of C10H12CaN2Na2O8.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 714
Phone Number:1-301-816-8251
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