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1.05151 SAFC

Potassium sulfate

powder EMPROVE® ESSENTIAL Ph Eur,BP,JP,E 515

Synonym: Potassium pyrosulfate, Potassium sulfate

  • CAS Number 7778-80-5

  • Empirical Formula (Hill Notation) K2O4S

  • Molecular Weight 174.26

  •  MDL number MFCD00011388

  •  E Number E515

  •  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
solubility   111 g/L
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

General description

powder EMPROVE® ESSENTIAL Ph Eur,BP,JP,E 515

Analysis Note

Assay (alkalimetric)≥ 99.0 %Assay (alkalimetric, calculated on dried substance)99.0 - 101.0 %Identitypasses testAppearance of solutionpasses testpH-value (5 %; water)5.5 - 8.5Acidity or alkalinitypasses testChloride (Cl)≤ 0.0040 %As (Arsenic)≤ 0.0002 %Ca (Calcium)≤ 0.0200 %Fe (Iron)≤ 0.0010 %Hg (Mercury)≤ 0.0001 %Mg (Magnesium)≤ 0.0020 %Na (Sodium)≤ 0.01 %Na (sodium)passes testPb (Lead)≤ 0.0002 %Se (Selenium)≤ 0.0030 %Residual solvents (ICH Q3C)excluded by manufacturing processLoss 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; E515
Conforms to the purity criteria on food additives according to the current European Commission Regulation.Corresponds to Ph Eur, BP, JP; E515
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Legal Information

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

Safety & Documentation

Safety Information

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