0.01 M Edetate Disodium VS
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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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Transfer 100 mL of 0.1 M edetate disodium VS to a 1000-mL volumetric flask. Dilute with water to volume.
Standardization
See Volumetric Solutions, 1. Introduction.
See Titrimetry 〈541〉.
Standardize by one of the following procedures. [Note - Other standardization procedures may be used. See Volumetric Solutions, 2. Preparation and Standardization, 2.3 Standardization.]
Standardization with visual endpoint: (USP 1-Aug-2024) Accurately weigh about 40 mg of chelometric standard calcium carbonate, previously dried at 210 (USP 1-Aug-2024) ° for 4 (USP 1-Aug-2024) h and cooled in a desiccator, or dried according to the label instructions, transfer to a 400-mL beaker, add 10 mL of water, and swirl to form a slurry. Cover the beaker with a watch glass, and introduce 4 mL of diluted hydrochloric acid from a pipet inserted between the lip of the beaker and the edge of the watch glass. Wash down the sides of the beaker, the outer surface of the pipet, and the watch glass with water, and dilute with water to about 200 mL. While stirring the solution, preferably with a magnetic stirrer, add about 30 mL of the edetate disodium solution from a 50-mL buret. Adjust the solution with sodium hydroxide TS to a pH of 12–13, add 300 mg of hydroxy naphthol blue, and continue the titration with edetate disodium solution to a blue endpoint.
M = (g CaCO₃ × 1000 × Assay / 100) / (100.09 × mL EDTA)
where Assay is the content/potency of calcium carbonate.
Standardization with potentiometric endpoint: Accurately weigh about 100 mg of chelometric standard calcium carbonate, previously dried at 210° for 4 h and cooled in a desiccator, or dried according to the label instructions, transfer to a 100-mL volumetric flask, add 10 mL of water, and swirl to form a slurry. Introduce diluted hydrochloric acid from a pipet until the calcium carbonate is completely dissolved, then dilute with water to volume. Transfer 10.0 mL of the above calcium carbonate solution into a 200-mL beaker and dilute with water to about 100 mL. Add 5 mL of ammoniacal buffer, pH 10, and titrate potentiometrically with the edetate disodium solution using a combined calcium ion-selective electrode.
M = (g CaCO₃ × 1000 × (Assay/100) × 0.1) / (100.09 × mL EDTA)
where Assay is the content/potency of calcium carbonate. (USP 1-Aug-2024)
[Note - If this volumetric solution is used in a qualitative application such as pH adjustment, dissolution medium, or diluent, its standardization is not required.]
