Edetic Acid

Edetic Acid BP EDTA

C10H16N2O8 -- 292.2 -- 60-00-4
Edetic Acid EDTA
Action and use
Chelating agent; pharmaceutical aid.

DEFINITION
(Ethylenedinitrilo)tetraacetic acid.
Content
98.0 per cent to 101.0 per cent. (EDTA)

CHARACTERS
Appearance
White or almost white, crystalline powder or colourless crystals.
Solubility
Practically insoluble in water and in ethanol (96 per cent). It dissolves in dilute  solutions of alkali hydroxides.

IDENTIFICATION
First identification: A.
Second identification: B, C.
A. Infrared absorption spectrophotometry as per prescribed method.
B. To 5 ml of water add 0.1 ml of ammonium thiocyanate solution and 0.1 ml of ferric chloride solution and mix. The solution is red. Add 0.5 ml of solution S (see Tests). The solution becomes yellowish.
C. To 10 ml of solution S 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.

TESTS
Solution S
Dissolve 5.0 g in 20 ml of dilute sodium hydroxide solution and dilute to 100 ml  with water.
Appearance of solution
Solution S is clear and colourless.
Impurity A
Liquid chromatography. Carry out the test protected from light. As per Monograph
—impurity A: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.1 per cent).
Chlorides
Maximum 200 ppm.
Iron
Maximum 80 ppm.
Heavy metals
Maximum 20 ppm.
Sulphated ash
Maximum 0.2 per cent, determined on 1.0 g.

Edetic Acid USP

Edetic Acid USP
EDTA
C10H16N2O8 292.24
Glycine, N,N′-1,2-ethanediylbis[N-(carboxymethyl)-.
(Ethylenedinitrilo)tetraacetic acid [60-00-4].

Edetic Acid contains not less than 98.0 percent and not more than 100.5 percent of C10H16N2O8.

Identification: Infrared Absorption 197K.
Residue on ignition: not more than 0.2%.
Heavy metals: 0.003%.
Iron— Char 3.0 g thoroughly, and heat in an oven at 500 until most of the carbon is consumed. Cool, add 0.15 mL of nitric acid, and heat at 500 until all of the carbon is consumed. Dissolve the residue in 2 mL of a mixture of equal volumes of hydrochloric acid and water, digest in a covered dish on a steam bath for 10 minutes, remove the cover, and evaporate to dryness. Dissolve the residue in 1 mL of 1 N acetic acid and 20 mL of hot water, digest for 5 minutes on a steam bath, cool, and dilute with water to 30 mL. To 2.0 mL of this solution add 2 mL of hydrochloric acid, and dilute with water to 50 mL. Add about 50 mg of ammonium persulfate and 3 mL of ammonium thiocyanate solution (3 in 10), mix, and transfer to a color-comparison tube. Treat in the same manner 2.0 mL of a solution of ferric ammonium sulfate, prepared by dissolving 43.2 mg of ferric ammonium sulfate in 10 mL of 2 N sulfuric acid and adding water to make 1000 mL, each mL representing 5 :g of Fe. The color of the test solution is not deeper than that of the solution containing the standard iron solution (0.005%).
Limit of nitrilotriacetic acid— To pass the test.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.