Edetate 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 Disodium Injection is a sterile solution of Edetate Disodium in Water for Injection, which, as a result of pH adjustment, contains varying amounts of the disodium and trisodium salts. It contains the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C₁₀H₁₄N₂Na₂O₈.

1 Packaging and storage—

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

USP Reference standards 〈11〉—

USP Edetate Disodium RS

Identification—Transfer a volume of Injection, equivalent to about 1 g of edetate disodium, to an evaporating dish, adjust with 3 N hydrochloric acid to a pH of 5.0, and evaporate on a steam bath to dryness: the residue responds to Identification tests A and C under Edetate Disodium.

Bacterial Endotoxins Test 〈85〉 —It contains not more than 0.2 USP Endotoxin Unit per mg of edetate disodium.

pH 〈791〉: between 6.5 and 7.5.

Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈1〉.

2 Assay—

Assay preparation—Dilute an accurately measured volume of Injection, equivalent to about 2 g of edetate disodium, with water to volume in a 100-mL volumetric flask, and mix.

Procedure—Proceed as directed for Procedure in the Assay under Edetate Disodium. Calculate the weight, in mg, of C₁₀H₁₄N₂Na₂O₈ in the volume of Injection taken by the formula:

(336.21/100.09)W(V_T/V)

in which 336.21 and 100.09 are the molecular weights of edetate disodium and calcium carbonate, respectively; W is the weight, in mg, of calcium carbonate; V_T is the volume, in mL, of the Assay preparation; and V is the volume in mL, of the Assay preparation consumed in the titration.