Edetate Disodium USP Disodium EDTA Edetate BP FCC IP Manufacturers |
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USP BP IP FCC
MSDS (Disodium EDTA Manufacturers; Edetate Disodium Manufacturers)
Disodium EDTA
IP BP Ph. Eur. USP ACS AR LR FCC Food Grades
Edetate Disodium
Specifications of Disodium Edetate BP Ph Eur Grade
C10H14N2Na2O8,2H2O -- 372.2 -- 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
C10H14N2Na2O8·2H2O 372.24
Glycine,
N,N′-1,2-ethanediylbis[N-(carboxymethyl)-,
disodium salt, dihydrate.
Disodium (ethylenedinitrilo)tetraacetate dihydrate [6381-92-6].
Anhydrous 336.21 [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
Disodium
Ethylenediaminetetraacetate;
Disodium
(Ethylenedinitrilo)tetraacetate;
Disodium Edetate
C10H14N2Na2O8·2H2O Formula wt 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.
Disodium Edetate,
Edetate Disodium IP BP USP FCC Manufacturers
Disodium EDTA,
EDTA Disodium IP BP USP FCC Manufacturers:
Muby Chem Ltd.
Toll manufacturing & Warehouse at Houston & Midland, Texas, USA and India
USA, Canada, Mexico Customers may e-mail: usa@mubygroup.com
Call 1-844-682-9243
Europe Africa Asia India Mumbai e-mail: info@mubygroup.com
Call +91-22-23774610
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