FERROUS GLUCONATE
Prepared at the 53rd JECFA (1999) and published in FNP 52 Add 7 (1999),
superseding specifications prepared at the 51st JECFA (1998), published in
FNP 52 Add 6 (1998). PMTDI 0.8 mg/kg bw for iron, established at the 27th
JECFA in 1983.
SYNONYMS INS No. 579
DEFINITION
Chemical names Iron (II) di-D-gluconate dihydrate, ferrous gluconate
C.A.S. number 299-29-6
Chemical formula C12H22FeO14 · 2H2O
Structural formula
Formula weight 482.17
Assay Not less than 95% on the dried basis
DESCRIPTION Fine yellowish-grey or pale greenish-yellow powder or granules having a
slight odour resembling that of burnt sugar
FUNCTIONAL USES Colour, stabilizer, nutrient supplement
CHARACTERISTICS
IDENTIFICATION
Solubility (Vol. 4) Soluble with slight heating in water; practically insoluble in ethanol
Test for ferrous salts Passes test
(Vol. 4)
Test for gluconate Passes test
(Vol.4)
PURITY
Loss on drying (Vol. 4) Not less than 6.5% and not more than 10.0% (105o, 16 h)
Reducing sugars Dissolve 0.5 g of the sample in 10 ml of water; warm, and make the solution
alkaline with 1 ml of ammonia TS. Pass hydrogen sulfide gas into the
solution to precipitate the iron, and allow the mixture to stand for 30 min to
coagulate the precipitate. Filter, and wash the precipitate with two
successive 5 ml portions of water. Acidify the combined filtrate and
washings with hydrochloric acid, and add 2 ml of dilute hydrochloric acid TS
in excess. Boil the solution until the vapours no longer darken lead acetate
paper, and continue to boil, if necessary, until concentrated to about 10 ml.
Allow to cool, add 5 ml of sodium carbonate TS and 20 ml of water; filter,
and adjust the volume of the filtrate to 100 ml. To 5 ml of the filtrate add 2
ml of alkaline cupric tartrate TS and boil for 1 min. No red precipitate should
be formed within 1 min.
Iron (III) Not more than 2%
Dissolve about 5 g of the sample, accurately weighed, in a mixture of 100
ml of water and 10 ml of hydrochloric acid in a 250-ml glass stoppered flask.
Add 3 g of potassium iodide, shake well, and allow to stand in the dark for 5
min. Titrate any liberated iodine with 0.1 N sodium thiosulfate, using starch
TS as the indicator. Each ml of 0.1 N sodium thiosulfate is equivalent to
5.585 mg of iron (Fe III).
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.”
METHOD OF Dissolve about 1.5 g of the dried sample, accurately weighed, in a mixture
ASSAY of 75 ml of water and 15 ml of dilute sulfuric acid TS in a 300-ml Erlenmeyer
flask, and add 250 mg of zinc dust. Close the flask with a stopper containing
a Bunsen valve, and allow to stand at room temperature for 20 min. Then
filter through a Gooch crucible containing a glass fibre filter paper coated
with a thin layer of zinc dust, and wash the crucible and contents with 10 ml
of dilute sulfuric acid TS, followed by 10 ml of water. Add
orthophenanthroline TS and titrate the filtrate in the suction flask
immediately with 0.1 N ceric sulfate. Perform a blank determination, and
make any necessary correction. Each ml of 0.1 N ceric sulfate is equivalent
to 44.61 mg of C12H22FeO14.