Additive 164

DISODIUM ETHYLENEDIAMINETETRAACETATE
Prepared at the 17th JECFA (1973), published in FNP 4 (1978) and FNP 52
(1992). Metals and arsenic specifications revised at the 61st JECFA (2003).
An ADI of 0-2.5 mg/kg bw was established at the 17th JECFA (1973)
SYNONYMS Disodium EDTA, disodium edetate; INS No. 386
DEFINITION
Chemical names Disodium salt of N,N'-1,2-Ethanediylbis[N-(carboxymethyl)glycine];
disodium dihydrogen ethylenediaminetetraacetate; disodium dihydrogen
(ethylene-dinitrilo)-tetraacetate
C.A.S. number 139-33-3
Chemical formula C10H14N2Na2O8 · 2H2O
Structural formula
Formula weight 372.24
Assay Not less than 99%
DESCRIPTION White, odourless crystalline granules or a white to nearly white powder
FUNCTIONAL USES Sequestrant, antioxidant synergist, preservative
CHARACTERISTICS
IDENTIFICATION
Solubility (Vol. 4) Freely soluble in water, practically insoluble in ethanol
Infrared absorption The infrared spectrum of the sample corresponds with that of a reference
standard (a Reference standard may be obtained from the U.S.
Pharmacopeia, 12601 Twin Brook Parkway, Rockville, Maryland 20852)
Test for sodium (Vol. 4) Passes test
Chelating activity to metal To 5 ml of water in a test tube add 2 drops of ammonium to thiocyanate TS
ions and 2 drops of ferric chloride TS. A deep red solution develops. Add about
50 mg of the sample and mix. The deep red colour disappears.
PURITY
pH (Vol. 4) 4.3 - 4.7 (1 in 100 soln)
Nitrilotriacetic acid Passes test

See description under TESTS
Lead (Vol. 4) Not more than 2 mg/kg
Determine using an atomic absorption technique appropriate to the
specified level. The selection of sample size and method of sample
preparation may be based on the principles of the method described in
Volume 4, “Instrumental Methods.”
TESTS
PURITY TESTS
Nitrilotriacetic acid Stock test solution

Transfer 10 g of the sample into a 100-ml volumetric flask, dissolve in 40 ml
of a (1 in 10) potassium hydroxide solution, dilute to volume with water, and
mix.
Diluted stock test solution

Pipette 10 ml of the "stock test solution" into a 100-ml volumetric flask,
dilute to volume with water, and mix.
Test preparation
Pipette 20 ml of the "diluted stock test solution" into a 150-ml beaker, add 1
ml of a (1 in 10) potassium hydroxide solution, 2 ml of a (1 in 10)
ammonium nitrate solution, and about 50 mg of eriochrome black T
indicator, and titrate with a (3 in 100) cadmium nitrate solution to a red end-
point. Record the volume, in ml, of the titrant required as V, and discard the
solution.
Pipette 20 ml of the "diluted stock test solution" into a 100-ml volumetric

flask, and add the volume V of the (3 in 100) cadmium nitrate solution
required in the initial titration, plus 0.05 ml in excess. Add 1.5 ml of a (1 in
10) potassium hydroxide solution, 10 ml of a (1 in 10) ammonium nitrate
solution, and 0.5 ml of methyl red TS, then dilute to volume with water and
mix.
Stock standard solution

Transfer 1.0 g of nitrilotriacetic acid into a 100-ml volumetric flask, dissolve
in 10 ml of a (1 in 10) potassium hydroxide solution, dilute to volume with
water, and mix.
Dilute stock standard solution

Pipette 1 ml of the "stock standard solution" and 10 ml of the "stock test
solution" into a 100-ml volumetric flask, dilute to volume with water, and
mix.
Standard preparation
Proceed as directed under "test preparation", using "diluted stock standard
solution" where "diluted stock test solution" is specified.
Polarographic test
Rinse a polarographic cell with a portion of the "standard preparation", then
add a suitable volume to the cell, immerse it in a constant-temperature bath
maintained at 25 ± 0.5o, and de-aerate by bubbling oxygen-free nitrogen
through the solution for 10 min. Insert the dropping mercury electrode of a
suitable polarograph, and record the polarogram from -0.6 to -1.2 volts at a
sensitivity of 0.006 microampere per mm, using a saturated calomel
electrode as the reference electrode. In the same manner, obtain a
polarogram for a portion of the "test preparation". The diffusion current
observed with the "test preparation" is not greater than 10% of the
difference between the diffusion currents observed with the "standard
preparation" and the "test preparation", respectively. (Note: An extra
polarographic wave appearing ahead of the nitrilotriacetic acid-cadmium
complex wave is probably due to uncomplexed cadmium. This wave should
be ignored in measuring the diffusion current).
METHOD OF Transfer about 5 g, accurately weighed, of the sample, into a 250-ml

ASSAY volumetric flask, dissolve in water, dilute to volume and mix, to give the
assay preparation. Place about 200 mg, accurately weighed, of reagent
grade calcium carbonate of known purity in a 400-ml beaker, add 10 ml of
water and swirl to form a slurry. Cover the beaker with a watch glass and
introduce 2 ml of dilute hydrochloric acid TS from a pipette inserted
between the lip of the beaker and the edge of the watch glass. Swirl the
contents of the beaker to dissolve the calcium carbonate. Wash down the
outer surface of the pipette, the watch glass and the sides of the beaker,
and dilute to about 100 ml with water. While stirring the solution, preferably
with a magnetic stirrer, add about 30 ml of the assay preparation from a 50-
ml burette. Add 15 ml of sodium hydroxide TS, 300 mg of hydroxynaphthol
blue indicator and continue the titration with the assay preparation to a blue
end point. Calculate the percentage of C10H14N2Na2O8 " 2H2O in the sample
by the formula:
where
WCaCO3 = the weight in grams of calcium carbonate;
VASSAY = the volume in ml of assay preparation; and
WSAMPLE = the weight in gram of the sample taken.

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DISODIUM ETHYLENEDIAMINETETRAACETATE

SYNONYMS Disodium EDTA, disodium edetate; INS No. 386

C.A.S. number 139-33-3

Chemical formula C10H14N2Na2O8 · 2H2O

Formula weight 372.24

Assay Not less than 99%

DESCRIPTION White, odourless crystalline granules or a white to nearly white powder

FUNCTIONAL USES Sequestrant, antioxidant synergist, preservative

Solubility (Vol. 4) Freely soluble in water, practically insoluble in ethanol

Test for sodium (Vol. 4) Passes test

pH (Vol. 4) 4.3 - 4.7 (1 in 100 soln)

Nitrilotriacetic acid Passes test

Nitrilotriacetic acid Stock test solution

Diluted stock test solution

Pipette 20 ml of the "diluted stock test solution" into a 100-ml volumetric

Stock standard solution

Dilute stock standard solution

METHOD OF Transfer about 5 g, accurately weighed, of the sample, into a 250-ml

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