L(+)-Histidine USP, Multi-Compendial

Résultats des tests de spécification

• Bulk Food Chemical:
  98.5 - 101.5 %
• Bulk Pharmaceutical Chemical:
  Passes Test
• USP - Assay (C₆H₉N₃O₂) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Specific Rotation [Å]²⁵ D (+):
  12.6 - 14.0 Degree
• USP - pH:
  7.0 - 8.5
• USP - Loss on Drying at 105°C:
  = 0.2 %
• USP - Residue on Ignition:
  = 0.4 %
• USP - Chloride (Cl):
  = 0.05 %
• USP - Sulfate (SO₄):
  = 0.03 %
• USP - Iron (Fe):
  = 0.003 %
• USP - Related Compounds - Individual Impurities:
  = 0.5 %
• USP - Related Compounds - Total Impurities:
  = 2.0 %
• FCC - Assay (C₆H₉N₃O₂) (dried basis):
  98.5 - 101.5 %
• FCC - Identification:
  Passes Test
• FCC - Lead (Pb):
  = 5 mg/kg
• FCC - Loss on Drying:
  = 0.2 %
• FCC - Residue on Ignition:
  = 0.2 %
• FCC - Specific Rotation [Å]²⁰ D (+):
  11.5 - 13.5 Degree
• EP/BP - Assay (C₆H₉N₃O₂) (dried basis):
  98.5 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Specific Rotation [Å]²⁰ D (+):
  11.4 - 12.4 Degree
• EP/BP-Ninhydrin-Positive Substances-Each:
  = 0.2 %
• EP/BP-Ninhydrin-Positive Substances-Total Impurities:
  = 0.5 %
• EP/BP - Chloride (Cl):
  = 200 ppm
• EP/BP - Sulfate (SO₄):
  = 300 ppm
• EP/BP - Ammonium (NH₄):
  = 0.02 %
• EP/BP - Iron (Fe):
  = 10 ppm
• EP/BP - Loss on Drying:
  = 0.5 %
• EP/BP - Ash (sulfated):
  = 0.1 %
• Endotoxin Concentration, IU/mg:
  For Information Only
• JP - Assay (C6H9N3O2) (dried basis):
  99.0 - 101.0 %
• JP - Ammonium (NH₄):
  = 0.02 %
• JP - Chloride (Cl):
  = 0.021 %
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Heavy Metals (as Pb):
  = 10 ppm
• JP - Iron (Fe):
  = 10 ppm
• JP - Identification:
  Passes Test
• JP - Loss on Drying at 105°C:
  = 0.3 %
• JP- Optical Rotation [Å]²⁰ D (+):
  11.8 - 12.8 Degree
• JP - Related Substances:
  Passes Test
• JP - pH:
  7.0 - 8.5
• JP - Residue on Ignition:
  = 0.10 %
• JP - Sulfate (SO₄):
  = 0.028 %