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1.06642 SAFC

Sodium sulfate decahydrate

cryst. EMPROVE® ESSENTIAL Ph Eur,BP,JPE,USP

Synonym: Sodium sulfate decahydrate

  • CAS Number 7727-73-3

  • Empirical Formula (Hill Notation) Na2O4S · 10H2O

  • Molecular Weight 322.20

  •  MDL number MFCD00149189

  •  EC Index Number 231-820-9

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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
  JPE
  Ph. Eur.
  USP
Quality Level   500
product line   Emprove® Essential
pH   5.2-8.0 (25 °C, 50 g/L in H2O, anhydrous substance)
mp   32.4 °C
density   1.464 g/cm3
bulk density   700 kg/m3
InChI   1S/2Na.H2O4S.10H2O/c;;1-5(2,3)4;;;;;;;;;;/h;;(H2,1,2,3,4);10*1H2/q2*+1;;;;;;;;;;;/p-2
InChI key   RSIJVJUOQBWMIM-UHFFFAOYSA-L
storage conditions   Store at +15°C to +25°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): ≤ 0.0005 %
Heavy metals (as Pb): ≤ 0.0010 %
As (Arsenic): ≤ 0.0002 %
Al (Aluminium): ≤ 0.0005 %
Ca (Calcium): ≤ 0.005 %
Fe (Iron): ≤ 0.0005 %
Mg (Magnesium): ≤ 0.001 %
Zn (Zinc): ≤ 0.001 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on drying (130 °C): 53.0 - 57.0 %
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, JPE, USP

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

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Safety Information

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