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Propanol-2, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, très pur suitable for use as excipient, SAFC®
    
 
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Propanol-2, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, très pur suitable for use as excipient, SAFC®
    
 

 

  • Environmentally Preferable:

 

 

  • Assay (GC):
    ≥ 99.5 %
  • Identity (IR):
    conforms
  • Identity B (USP):
    conforms
  • Identity (JP):
    conforms
  • Appearance:
    conforms
  • Clarity of solution:
    conforms
  • Acidity or alkalinity:
    conforms
  • Acidity:
    conforms
  • Refractive index (n 20/D):
    1.376 - 1.378
  • Density (d 20 °C/20 °C):
    0.785 - 0.788
  • Density (d 25 °C/25 °C):
    0.783 - 0.787
  • Boiling range (81-83°C):
    ≥ 94 % (v/v)
  • Absorbance (at 230 nm):
    ≤ 0.300
  • Absorbance (at 250 nm):
    ≤ 0.100
  • Absorbance (at 270 nm):
    ≤ 0.030
  • Absorbance (at 290 nm):
    ≤ 0.020
  • Absorbance (at 310 nm):
    ≤ 0.010
  • The spectrum shows a steadily descending curve with no observable peaks or shoulders:
    conforms
  • Peroxides:
    conforms
  • Volatile Impurities (GC) (individual):
    ≤ 0.1 % (v/v)
  • Volatile Impurities (GC) (total):
    ≤ 1.0 % (v/v)
  • Benzene and related substances (GC) (Benzene):
    ≤ 2 ppm
  • Benzene and related substances (GC) (total of impurities apart from 2-butanol):
    ≤ 0.3 %
  • Cyclohexane (GC):
    ≤ 50 ppm
  • Acetone (GC):
    ≤ 50 ppm
  • Ethanol (GC):
    ≤ 50 ppm
  • 1-Propylalcohol (GC):
    ≤ 50 ppm
  • Isopropylether (GC):
    ≤ 0.01 %
  • Other residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Evaporation residue:
    ≤ 0.0020 %
  • Water:
    ≤ 0.20 %

 

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