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1.04900 SAFC

Potassium bromide

EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP

Synonym: Hydrobromic Acid Potassium Salt, Potassium bromide

  • CAS Number 7758-02-3

  • Empirical Formula (Hill Notation) BrK

  • Molecular Weight 119.00

  •  MDL number MFCD00011358

  •  EC Index Number 231-830-3

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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
  JP
  Ph. Eur.
  USP
Quality Level   500
vapor pressure   1.3 hPa ( 795 °C)
product line   Emprove® Essential
potency   >2000 mg/kg LD50, oral (Rat)
pH   5.5-8.5 (20 °C, 50 g/L in H2O)
bp   1435 °C/1013 hPa
mp   730 °C
solubility   650 g/L
density   2.75 g/cm3 at 20 °C
bulk density   900‑1000 kg/m3
InChI   1S/BrH.K/h1H;/q;+1/p-1
InChI key   IOLCXVTUBQKXJR-UHFFFAOYSA-M
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay according to Ph Eur/BP (argentometric; calculated on driedsubstance): 99.5 - 100.5 %
Assay according to USP (argentometric; calculated on dried substance): 99.5 - 100.5 %
Assay according to JP (argentometric; calculated on dried substance): 99.5 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Acidity or alkalinity: passes test
Alkalinity: passes test
Bromate(BrO₃): passes test
Chloride (Cl): ≤ 0.45 %
Iodide (I): passes test
Sulfate (SO₄): ≤ 0.005 %
Heavy metals (as Pb): ≤ 0.001 %
As (Arsenic): ≤ 0.0002 %
Ba (Barium): passes test
Fe (Iron): ≤ 0.001 %
Na (Sodium): ≤ 0.15 %
Pb (Lead)*: ≤ 0.00005 %
Magnesium and alkaline-earth metals (as Ca): ≤ 0.02 %
Residual solvents (Ph Eur/ICH): excluded by manufacturing process
Loss on Drying (105 °C): ≤ 0.5 %
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,JP, USP

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