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1.02160 SAFC

Calcium sulfate dihydrate

precipitated EMPROVE® ESSENTIAL Ph Eur,BP,E 516

Synonym: Calcium sulfate dihydrate

  • CAS Number 10101-41-4

  • Empirical Formula (Hill Notation) CaO4S · 2H2O

  • Molecular Weight 172.17

  •  MDL number MFCD00149625

  •  E Number E516

  •  EC Index Number 231-900-3

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Mineral Salts, Solid Dosage Forms More...
Agency/Method   BP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
potency   >10000 mg/kg LD50, oral (Rat)
pH   7.0 (20 °C, 50 g/L in H2O, slurry)
solubility   2 g/L
density   2.32 g/cm3 at 20 °C
bulk density   400‑600 kg/m3
InChI   1S/Ca.H2O4S.2H2O/c;1-5(2,3)4;;/h;(H2,1,2,3,4);2*1H2/q+2;;;/p-2
InChI key   PASHVRUKOFIRIK-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (complexometric): 98.0 - 102.0 %
Assay (complexometric; calculated on dried substance): ≥ 99.0 %
Identity: passes test
Acidity or alkalinity: passes test
Chloride (Cl): ≤ 0.0300 %
Fluoride (F): ≤ 0.0030 %
Heavy metals (as Pb): ≤ 0.001 %
As (Arsenic): ≤ 0.0003 %
Fe (Iron): ≤ 0.002 %
Hg (Mercury): ≤ 0.0001 %
Na (Sodium): ≤ 0.2 %
Pb (Lead): ≤ 0.0002 %
Se (Selenium): ≤ 0.0030 %
Sr (Strontium): ≤ 0.05 %
Zn (Zinc): ≤ 0.002 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on ignition (800 °C): 18.0 - 22.0 %
Loss on drying (250 °C): ≤ 23.0 %
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,E 516
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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