Edetate Calcium Disodium Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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.

1 Packaging and storage

—Preserve in single-dose containers, preferably of Type I glass.

USP Reference standards 〈11〉—

USP Edetate Calcium Disodium RS

2 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 Test 〈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 in Injections 〈788〉: meets the requirements for small-volume injections.

Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈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.