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1.01042 SAFC

Aluminium potassium sulfate dodecahydrate

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Synonym: Aluminium potassium sulfate dodecahydrate, Potassium aluminium sulfate, Alum potassium, Potassium alum

  • CAS Number 7784-24-9

  • Linear Formula KAl(SO4)2 · 12 H2O

  • Molecular Weight 474.39

  •  MDL number MFCD00149143

  •  EC Index Number 233-141-3

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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
product line   Emprove® Essential
pH   3.0-3.5 (20 °C, 100 g/L in H2O)
mp   92.5 °C
solubility   139 g/L
density   1.75 g/cm3 at 20 °C
bulk density   900 kg/m3
InChI   1S/Al.K.2H2O4S.12H2O/c;;2*1-5(2,3)4;;;;;;;;;;;;/h;;2*(H2,1,2,3,4);12*1H2/q+3;+1;;;;;;;;;;;;;;/p-4
InChI key   GNHOJBNSNUXZQA-UHFFFAOYSA-J
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (complexometric): 99.0 - 100.5 %
Assay (complexometric; calculated on dried substance): 99.0 - 100.5 %
Identity: passes test
Appearance of solution: passes test
pH-value (10 %; water): 3.0 - 3.5
Heavy metals (as Pb): ≤ 0.002 %
Cr (Chromium): ≤ 0.0003 %
Fe (Iron): ≤ 0.01 %
NH₄ (Ammonium): ≤ 0.2 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on drying (400 °C): 43.0 - 46.0 %
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,USP

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

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