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1.01750 SAFC

Barium sulfate

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Synonym: Barium sulfate, Blanc fixe

  • CAS Number 7727-43-7

  • Empirical Formula (Hill Notation) BaO4S

  • Molecular Weight 233.39

  •  MDL number MFCD00003455

  •  EC Index Number 231-784-4

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Ingredients for Liquid Dosage Formulation, Liquid Dosage Forms More...
Agency/Method   BP
  Ph. Eur.
  USP
Quality Level   500
product line   Emprove® Essential
potency   >20000 mg/kg LD50, oral (Rat)
pH   3.5-10.0 (20 °C, 100 g/L in H2O, suspension)
mp   1380 °C
density   4.5 g/cm3 at 20 °C
bulk density   500 kg/m3
InChI   1S/Ba.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
InChI key   TZCXTZWJZNENPQ-UHFFFAOYSA-L
storage conditions   no restrictions.

Description

Application

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (RFA): 97.5 - 100.5 %
Identity: passes test
Substances soluble in acid (Ph Eur): ≤ 0.3 %
Substances soluble in acid (USP): ≤ 0.3 %
Soluble Barium salts (Ph Eur): ≤ 0.0010 %
Soluble Barium salts (USP): ≤ 0.001 %
Acidity or alkalinity: passes test
pH (10% aqueous suspension): 3.5 - 10.0
Sulphide (S): ≤ 0.00005 %
Heavy metals (as Pb): ≤ 0.0010 %
Al (Aluminium): ≤ 0.0050 %
Residual solvents (ICH Q3C): excluded by the production process
Oxidizable Sulfur: passes test
Loss on ignition (at 600 °C): ≤ 2.0 %
Bulk density: about 50
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 (*).
Coprresponds to Ph Eur, BP, USP

Legal Information

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

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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