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1.03762 SAFC

Ammonium iron(III) citrate

about 18% Fe DAC

Synonym: Ammonium iron(III) citrate

  • CAS Number 1185-57-5

  • Empirical Formula (Hill Notation) C6H8O7 · xFe · xH3N

  •  MDL number MFCD03099410

  •  EC Index Number 214-686-6

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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

Analysis Note

Assay (iodometric, Fe calculated on dried substance): 17.1 - 18.9 %
Identity (ammonia): passes test
Identity (Fe): passes test
Identity (Citrate): passes test
Appearance of solution (100 g/l, water): Yellow brown solution without sediment.
pH (100 g/l, water): 6.0 - 8.0
Chloride (Cl): ≤ 500 ppm
Sulfate (SO₄): ≤ 1.5 %
Heavy metals (as Pb): ≤ 50 ppm
Al (Aluminium): ≤ 50 ppm
As (Arsenic): ≤ 4 ppm
As (Arsenic) (ICP): ≤ 4 ppm
Co (Cobalt)*: ≤ 50 ppm
Cu (Copper)*: ≤ 30 ppm
Ni (Nickel)*: ≤ 100 ppm
V (Vanadium)*: ≤ 50 ppm
Residual solvents (Ph Eur/ICH): excluded by manufacturing process
Fe(III) (not to fast complex): passes test
Tartrate (C₄H₄O₆): passes test
Loss on Drying (105 °C): ≤ 6.0 %
Elementverunreinigungen gemäß der Leitlinie ICH Q3D (Guideline for Elemental Impurities) sind in der Spezifikation berücksichtigt. Elemente der Klassen 1-3 werden nicht oberhalb des Option-1-Limit gemäß ICH Q3D erwartet, wenn diese nicht spezifiziert und gekennzeichnet (*) sind.
Corresponds to DAC

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