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1.06360 SAFC

Sodium bromide

EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP

Synonym: Bromo sodium, Sodium bromide

  • CAS Number 7647-15-6

  • Empirical Formula (Hill Notation) BrNa

  • Molecular Weight 102.89

  •  MDL number MFCD00003475

  •  EC Index Number 231-599-9

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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
  JP
  Ph. Eur.
  USP
Quality Level   500
vapor pressure   1.3 hPa ( 806 °C)
product line   Emprove® Essential
potency   3500 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rabbit)
pH   5.74 (22.5 °C, 430 g/L in H2O)
solubility   946 g/L
density   3.2 g/cm3 at 25 °C
bulk density   1750 kg/m3
InChI   1S/BrH.Na/h1H;/q;+1/p-1
InChI key   JHJLBTNAGRQEKS-UHFFFAOYSA-M
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay according to Ph Eur/BP (argentometric; calculated on driedsubstance): 99.0 - 100.5 %
Assay according to USP (argentometric; calculated on dried substance): 99.0 - 100.5 %
Assay according to JP (argentometric; calculated on dried substance): 99.0 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Alkalinity: passes test
Acidic or alkaline impurities: passes test
Bromate(BrO₃): passes test
Chloride (Cl): ≤ 0.2 %
Iodide (I): passes test
Sulfate (SO₄): ≤ 0.005 %
Heavy metals (as Pb): ≤ 0.001 %
As (Arsenic): ≤ 0.0002 %
Ba (Barium): passes test
Ca (Calcium): ≤ 0.005 %
Fe (Iron): ≤ 0.001 %
Mg (Magnesium): ≤ 0.002 %
Magnesium and alkaline-earth metals (as Ca): ≤ 0.02 %
Residual solvents (Ph Eur/ICH): excluded by manufacturing process
Loss on drying (110 °C): ≤ 3.0 %
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 (*).
Conforms to Ph Eur, BP, USP, JP

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

Safety & Documentation

Safety Information

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