Disodium Edetate

Disodium Edetate BP

Disodium Edetate BP
C10H14N2Na2O8,2H2O -- 372.2 -- CAS 139-33-3

DEFINITION
Disodium dihydrogen (ethylenedinitrilo)tetraacetate dihydrate.
Content
98.5 per cent to 101.0 per cent.

CHARACTERS
Appearance
White or almost white, crystalline powder.
Solubility
Soluble in water, practically insoluble in ethanol (96 per cent).

IDENTIFICATION
First identification A, B, D.
Second identification B, C, D.
A. Infrared absorption spectrophotometry.
B. Dissolve 2 g in 25 ml of water, add 6 ml of lead nitrate solution, shake and add 3 ml of potassium iodide solution. No yellow precipitate is formed. Make alkaline to red litmus paper by the addition of dilute ammonia. Add 3 ml of ammonium oxalate solution R. No precipitate is formed.
C. Dissolve 0.5 g in 10 ml of water and add 0.5 ml of calcium chloride solution. Make alkaline to red litmus paper by the addition of dilute ammonia and add 3 ml of ammonium oxalate solution. No precipitate is formed.
D. It gives the reactions of sodium.

TESTS
Solution S
Dissolve 5.0 g in carbon dioxide-free water and dilute to 100 ml with the same  solvent.
Appearance of solution
Solution S is clear and colourless.
pH
4.0 to 5.5 for solution S.
Impurity A
Liquid chromatography. Carry out the test protected from light.
To pass the test
Limit:—impurity A: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.1 per cent).
Iron
Maximum 80 ppm.
Heavy metals
Maximum 20 ppm

IMPURITIES
Specified impurities A
A. nitrilotriacetic acid.

Edetate Disodium USP

Edetate Disodium USP
C10H14N2Na2O8·2H2O 372.24
Glycine, N,N′-1,2-ethanediylbis[N-(carboxymethyl)-, disodium salt, dihydrate.
Disodium (ethylenedinitrilo)tetraacetate dihydrate [CAS 6381-92-6].
Anhydrous 336.21 [CAS 139-33-3].
Edetate Disodium contains not less than 99.0 percent and not more than 101.0 percent of C10H14N2Na2O8, calculated on the dried basis.

Identification—
A: Infrared Absorption 197K : un-dried.
B: To 5 mL of water in a test tube add 2 drops of ammonium thiocyanate TS and 2 drops of ferric chloride TS, and mix. To the deep red solution add about 50 mg of Edetate Disodium, and mix: the red color is discharged, leaving a yellowish solution.
C: It responds to the flame test for Sodium.
pH: between 4.0 and 6.0, in a solution (1 in 20).
Loss on drying— Dry it at 150 for 6 hours: it loses not less than 8.7% and not more than 11.4% of its weight.
Calcium— To a solution (1 in 20) add 2 drops of methyl red TS, and neutralize with 6 N ammonium hydroxide. Add 3 N hydrochloric acid drop-wise until the solution is just acid, and then add 1 mL of ammonium oxalate TS: no precipitate is formed.
Heavy metals: 0.005%.
Limit of nitrilotriacetic acid— not more than 0.1% of nitrilotriacetic acid is found.

Disodium EDTA FCC Food Grade

Disodium Ethylenediaminetetraacetate; Disodium
(Ethylenedinitrilo)tetraacetate; Disodium Edetate
C10H14N2Na2O8·2H2O Formula weight 372.24
INS: 386 CAS: [6381-92-6]

DESCRIPTION
EDTA Disodium occurs as a white, crystalline powder. It is soluble in water.

REQUIREMENTS
Identification
A. A 1:20 aqueous solution responds to the flame test for Sodium.
B. Add 2 drops of ammonium thiocyanate TS and 2 drops of ferric chloride TS to 5 mL of water in a test tube. Add about 50 mg of sample to the deep red solution so obtained, and mix. The deep red color disappears.
C. The infrared absorption spectrum of a potassium bromide dispersion of sample exhibits relative maxima at the same wavelengths as those of a similar preparation of USP Edetate Disodium Reference Standard.

Assay: Not less than 99.0% and not more than 101.0% of C10H14N2Na2O8·2H2O.
Calcium: Negative.
Lead: Not more than 10 mg/kg.
Nitrilotriacetic Acid: Not more than 0.1%.
pH of a 1:100 Solution: Between 4.3 and 4.7.

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