Edetate Disodium EDTA Disodium Edetate Specifications of Commercial Pure & BP Ph Eur USP FCC Food Grade Manufacturers & Exporters
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Edetate Disodium EDTA Disodium Edetate CAS Number 6381-92-6 & 139-33-3
Edetate Disodium USP Grade Specifications:
C10H14N2Na2O8-2H2O --- 372.24
C10H14N2Na2O8 --- 336.21
Glycine, N,N -1,2-ethanediylbis[N-(carboxymethyl)-, disodium salt, dihydrate;
Disodium (ethylenedinitrilo)tetraacetate dihydrate --- CAS 6381-92-6
Anhydrous --- CAS 139-33-3
DEFINITION
Edetate Disodium contains NLT 99.0% and NMT 101.0% of edetate disodium (C10H14N2Na2O8), calculated on the dried basis.
IDENTIFICATION
A. Infrared Absorption
B.
Sample: 50 mg
Analysis: To 5 mL of water in a test tube add 2 drops of ammonium thiocyanate and 2 drops of ferric chloride. To the deep red solution add the Sample.
Acceptance criteria: The red color is discharged, leaving a yellowish solution.
C. Identification Tests-General, Sodium: It meets the requirements of the pyroantimonate precipitation test.
Calcium:
Sample solution: 1 g of Edetate Disodium in 20 mL of water
Analysis: To the Sample solution add 2 drops of methyl red and neutralize with 6 N ammonium hydroxide. Add 3 N hydrochloric acid dropwise until the solution is just acidic, and then add 1 mL of ammonium oxalate.
Acceptance criteria: No precipitate is formed.
Limit of Nitrilotriacetic Acid: To pass the test by Chromatography.
pH:
Sample solution: 50 mg/mL
Acceptance criteria: 4.0 to 6.0
Loss on Drying:
Analysis: Dry at 150C for 6 h.
Acceptance criteria: 8.7% to 11.4%
Packaging and Storage:Preserve in well-closed containers.
Disodium Edetate BP Ph Eur Grade Specifications
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.
Specifications of Disodium EDTA FCC Food Grade
Disodium Ethylenediaminetetraacetate; Disodium (Ethylenedinitrilo)tetraacetate; Disodium Edetate
C10H14N2Na2O8-2H2O Formula wt 372.24
INS: 386 CAS: [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.
SDS MSDS of Edetate Disodium EDTA Disodium Edetate BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers |
