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1.05150 SAFC

Potassium sulfate

cryst. EMPROVE® ESSENTIAL Ph Eur,BP,JP

Synonym: Potassium pyrosulfate, Potassium sulfate

  • CAS Number 7778-80-5

  • Empirical Formula (Hill Notation) K2O4S

  • Molecular Weight 174.26

  •  MDL number MFCD00011388

  •  EC Index Number 231-915-5

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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
  JP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
potency   6600 mg/kg LD50, oral (Rat)
pH   5.5-8.5 (20 °C, 50 g/L in H2O)
bp   1689 °C/1013 hPa
mp   1069 °C
density   2.66 g/cm3 at 20 °C
bulk density   800 kg/m3
InChI   1S/2K.H2O4S/c;;1-5(2,3)4/h;;(H2,1,2,3,4)/q2*+1;/p-2
InChI key   OTYBMLCTZGSZBG-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (alkalimetric, calculated on dried substance): 99.0 - 101.0 %
Identity: passes test
Appearance of solution: passes test
Acidity or alkalinity: passes test
Chloride (Cl): ≤ 0.0040 %
Heavy metals (as Pb): ≤ 0.0010 %
As (Arsenic): ≤ 0.0002 %
Ca (Calcium): ≤ 0.0200 %
Fe (Iron): ≤ 0.0010 %
Mg (Magnesium): ≤ 0.0020 %
Na (Sodium): ≤ 0.01 %
Na (sodium): passes test
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on drying (130 °C): ≤ 1.0 %
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,JP

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