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1.05829 SAFC

Magnesium hydroxide carbonate

heavy extra pure Ph Eur,BP,USP,E 504

Synonym: Magnesium carbonate basic, Magnesium hydroxide carbonate

  • CAS Number 12125-28-9

  •  E Number E504

  •  EC Index Number 235-192-7

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Mineral Salts,
Agency/Method   BP
  Ph. Eur.
  USP
Quality Level   400
assay   40.0-43.5% Mg (as MgO) basis (USP)
  40.0-43.5% Mg (as MgO) basis (complexometric)
form   solid
pH   10.5 (20 °C, 50 g/L in H2O, suspension)
mp   600 °C (decomposition)
solubility   water: insoluble at 20 °C
density   2.16 g/cm3 at 20 °C
anion traces   chloride (Cl-): ≤0.02%
  sulfate (SO42-): ≤0.3%
cation traces   As: ≤0.0002%
  Ca: ≤0.4%
  Fe: ≤0.005%
  Hg: ≤0.0001%
  Na: ≤0.1%
  Ni: ≤0.0100%
  Pb: ≤0.0002%
  Si: ≤0.05%
  V: ≤0.0010%
  heavy metals (as Pb): ≤0.001%
InChI   1S/CH2O3.Mg.H2O/c2-1(3)4;;/h(H2,2,3,4);;1H2/q;+2;/p-3
InChI key   OUHCLAKJJGMPSW-UHFFFAOYSA-K
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (complexometric calculated as Magnesiumoxide): 40.0 - 43.5 %
Assay USP (calculated as Magnesiumoxide): 40.0 - 43.5 %
Identity: passes test
Appearance of solution: passes test
Substances soluble in water: ≤ 1.0 %
soluble salts: ≤ 1.0 %
Substances insoluble in acetic acid: ≤ 0.05 %
Substances insoluble in acid: ≤ 0.05 %
Chloride (Cl): ≤ 0.02 %
Sulfate (SO₄): ≤ 0.3 %
Heavy metals (as Pb): ≤ 0.001 %
As (Arsenic): ≤ 0.0002 %
Ca (Calcium): ≤ 0.4 %
Fe (Iron): ≤ 0.005 %
Hg (Mercury): ≤ 0.0001 %
Na (Sodium): ≤ 0.1 %
Ni (Nickel)*: ≤ 0.0100 %
Pb (Lead): ≤ 0.0002 %
Si (Silicon): ≤ 0.05 %
V (Vanadium)*: ≤ 0.0010 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Bulk density: ≥ 0.25 g/ml
Total aerobic microbial count: ≤ 2000 CFU/g
Total yeast and mould count: ≤ 200 CFU/g
E.coli (absent in 1 g): passes test
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 Ph Eur, BP, USP, E 504
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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