U.S. PHARMACOPEIA

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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 180 mg and not more than 220 mg of C10H12CaN2Na2O8.
Packaging and storage— Preserve in single-dose containers, preferably of Type I glass.
Identification—
A: Transfer a volume of Injection, equivalent to about 1 g of edetate calcium disodium, to an evaporating dish, and evaporate on a steam bath to dryness: the residue responds to Identification test A under Edetate Calcium Disodium.
B: It responds to Identification test B under Edetate Calcium Disodium.
Bacterial endotoxins 85— It contains not more than 0.01 USP Endotoxin Unit per mg of edetate calcium disodium.
pH 791: between 6.5 and 8.0.
Particulate matter 788: meets the requirements for small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Dilute an accurately measured volume of Injection, equivalent to about 1 g of edetate calcium disodium with water to about 75 mL. Add 25 mL of 1 N acetic acid and 1 mL of diphenylcarbazone TS, mix, and titrate slowly with 0.1 M mercuric nitrate VS to the appearance of the first purplish color. Perform a blank determination, and make any necessary correction. Each mL of 0.1 M mercuric nitrate is equivalent to 37.43 mg of C10H12CaN2Na2O8.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 779
Phone Number : 1-301-816-8251