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1.03761 SAFC

Ammonium iron(III) citrate

approx. 28% Fe DAC

Synonym: Ammonium iron(III) citrate

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Mineral Salts, Solid Dosage Forms,
Agency/Method   DAC
Quality Level   100
potency   >2000 mg/kg LD50, oral (Rat)
pH   6-8 (20 °C, 100 g/L in H2O)
solubility   1200 g/L
InChI   1S/C6H8O7.Fe.H3N/c7-3(8)1-6(13,5(11)12)2-4(9)10;;/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12);;1H3/q;+3;/p-3
InChI key   FRHBOQMZUOWXQL-UHFFFAOYSA-K
storage conditions   no restrictions.

Description

General description

approx. 28% Fe DAC

Application

Ammonium iron(III) citrate approx. 28% Fe DAC. CAS 1185-57-5, pH 6 - 8 (100 g/l, H₂O, 20 °C).

Analysis Note

Assay (iodometric, Fe calculated on dried substance)26.6 - 29.4 %Identity (ammonia)passes testIdentity (Fe)passes testIdentity (Citrate)passes testAppearance of solution (100 g/l, water)Dark brown solution without sediment.pH (100 g/l, water)6.0 - 8.0Chloride (Cl)≤ 500 ppmSulfate (SO₄)≤ 1.5 %Heavy metals (as Pb)≤ 50 ppmAl (Aluminium)≤ 100 ppmAs (Arsenic)≤ 4 ppmAs (Arsenic) (ICP)≤ 4 ppmCo (Cobalt)*≤ 50 ppmCu (Copper)*≤ 30 ppmNi (Nickel)*≤ 100 ppmSe (Selenium)*≤ 8 ppmV (Vanadium)*≤ 50 ppmFe(III) (not to fast complex)passes testResidual solvents (Ph Eur/ICH)excluded by manufacturing processTartrate (C₄H₄O₆)passes testLoss on Drying (105 °C)≤ 6.0 %Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to DAC

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