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ANNEX I

E 578 CALCIUM GLUCONATE

SynonymsCalcium salt of D-gluconic acid
Definition
Chemical nameCalcium di-D-gluconate
Einecs206-075-8
Chemical formulaC12H22CaO14 (anhydrous)
C12H22CaO14 · H2O (monohydrate)
Molecular weight430,38 (anhydrous form)
448,39 (monohydrate)
AssayContent not less than 98,0 % and not more than 102 % on the anhydrous and monohydrate basis
DescriptionOdourless, white crystalline granules or powder, stable in air
Identification
A.Positive test for calcium and for gluconate
B.Solubility
Soluble in water, insoluble in ethanol
C.pH of a 5 % solution
Between 6,0 and 8,0
Purity
Loss on dryingNot more than 3,0 % (105 oC, 16h) (anhydrous)
Not more than 2,0 % (105 oC, 16h) (monohydrate)
Reducing substancesNot more than 1,0 % (as D-glucose)
LeadNot more than 2 mg/kg