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1.04924 SAFC

Potassium carbonate

EMPROVE® ESSENTIAL Ph Eur,USP,E 501

Synonym: Potassium carbonate, potash

  • CAS Number 584-08-7

  • Empirical Formula (Hill Notation) CK2O3

  • Molecular Weight 138.21

  •  MDL number MFCD00011382

  •  E Number E501

  •  EC Index Number 209-529-3

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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   Ph. Eur.
  USP
Quality Level   500
product line   Emprove® Essential
potency   >2000 mg/kg LD50, oral (Rat)
pH   11.5-12.5 (20 °C, 50 g/L in H2O)
mp   891 °C
density   2.43 g/cm3 at 20 °C
bulk density   750 kg/m3
InChI   1S/CH2O3.2K/c2-1(3)4;;/h(H2,2,3,4);;/q;2*+1/p-2
InChI key   BWHMMNNQKKPAPP-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (acidimetric; calculated on dried substance): 99.5 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Insoluble substances: passes test
Chloride (Cl): ≤ 0.005 %
Sulfate (SO₄): ≤ 0.01 %
Heavy metals (as Pb): ≤ 0.0005 %
As (Arsenic): ≤ 0.0002 %
Ca (Calcium): ≤ 0.005 %
Fe (Iron): ≤ 0.001 %
Hg (Mercury): ≤ 0.0001 %
Pb (Lead): ≤ 0.0002 %
Residual solvents (Ph Eur/USP/ICH): excluded by manufacturing process
Loss on drying (180 °C): ≤ 0.5 %
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 (*).
Conforms to Ph Eur, USP, E501
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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