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1.02143 SAFC

Calcium phosphate

dried EMPROVE® ESSENTIAL Ph Eur,BP,E 341 (iii)

Synonym: Calcium phosphate, penta-Calcium hydroxide triphosphate, Calcium phosphate tribasic, Tricalcium orthophosphate

  • CAS Number 7758-87-4

  • Empirical Formula (Hill Notation) Ca3O8P2

  • Molecular Weight 310.18

  •  MDL number MFCD00015984

  •  E Number E341 (iii)

  •  EC Index Number 231-840-8

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Mineral Salts,
Agency/Method   BP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
potency   >5000 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rabbit)
particle size   0.063 mm
pH   6-8 (20 °C, 50 g/L in H2O, suspension)
mp   1670 °C
density   3.14 g/cm3 at 20 °C
bulk density   250 kg/m3
InChI   1S/3Ca.2H3O4P/c;;;2*1-5(2,3)4/h;;;2*(H3,1,2,3,4)/q3*+2;;/p-6
InChI key   QORWJWZARLRLPR-UHFFFAOYSA-H
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay Ca (complexometric): 35.0 - 40.0 %
Assay (as Ca₃(PO₄)₂ (calc. o. ignited subst.)): ≥ 90.2 %
Identity: passes test
Substances insoluble in hydrochloric acid: ≤ 0.1 %
Carbonate (as CO₂): passes test
Chloride (Cl): ≤ 0.1 %
Fluoride (F): ≤ 0.0050 %
Sulfate (SO₄): ≤ 0.5 %
Al (Aluminium): ≤ 0.0200 %
As (Arsenic)*: ≤ 0.0001 %
Cd (Cadmium)*: ≤ 0.0001 %
Fe (Iron): ≤ 0.0400 %
Hg (Mercury): ≤ 0.0001 %
Mg (Magnesium): ≤ 0.3 %
Na (Sodium): ≤ 0.2 %
Pb (Lead)*: ≤ 0.0001 %
Si (Silicon): ≤ 0.05 %
V (Vanadium)*: ≤ 0.0010
Heavy metals (as Pb): ≤ 0.001 %
Residual solvents (ICH Q3C): excluded by production process
Loss on ignition (800 °C): ≤ 8.0 %
Particle size (< 0.063 mm): about 98 %
Flowability (Hausner Ratio): 1.3 - 1.6
Bulk density: 0.20 - 0.40 g/ml
Compacted bulk density: 0.30 - 0.50 g/ml
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, E 341 (iii)
Conforms to the purity criteria on food additives, except for use as additive in infant and young child nutrition, according to the current European Commission Regulation.

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Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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