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1.04852 SAFC

Potassium hydrogen carbonate

EMPROVE® ESSENTIAL Ph Eur,BP,USP,FCC,E 501

Synonym: Potassium bicarbonate, Potassium hydrogen carbonate

  • CAS Number 298-14-6

  • Empirical Formula (Hill Notation) CHKO3

  • Molecular Weight 100.12

  •  MDL number MFCD00011402

  •  E Number E501

  •  EC Index Number 206-059-0

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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   500
reg. compliance   FCC
product line   Emprove® Essential
potency   >2000 mg/kg LD50, oral (Rat)
pH   8.4-8.6 (20 °C, 99 g/L in H2O)
solubility   362 g/L
density   2.17 g/cm3 at 20 °C
InChI   1S/CH2O3.K/c2-1(3)4;/h(H2,2,3,4);/q;+1/p-1
InChI key   TYJJADVDDVDEDZ-UHFFFAOYSA-M
storage conditions   Store at +15°C to +25°C.

Description

Analysis Note

Assay (acidimetric; calculated on dried substance): 99.5 - 101.0 %
Identity: passes test
Appearance of solution: passes test
pH-value (5 %; water): ≤ 8.6
Carbonate: passes test
Carbonate (as potassium carbonate): ≤ 2.5 %
Chloride (Cl): ≤ 0.007 %
Sulfate (SO₄): ≤ 0.01 %
Heavy metals (as Pb): ≤ 0.0005 %
As (Arsenic): ≤ 0.0002 %
Ca (Calcium): ≤ 0.005 %
Fe (Iron): ≤ 0.001 %
Hg (Mercury)*: ≤ 0,00003
Na (Sodium): ≤ 0.03 %
NH₄ (Ammonium): ≤ 0.002 %
Pb (Lead): ≤ 0.0002 %
Si (Silicon): ≤ 0.03 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on drying (Silica gel): ≤ 0.25 %
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, FCC, E 501
Conforms to the purity criteria on food additives 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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