Specification Test Results

• Meets B.P. Chemical Specifications:
  98.5 - 101.5%
• Meets E.P. Chemical Specifications:
  Passes Test
• GMP Manufactured Product:
  -34.7 - -32.7 Degree
• Meets U.S.P Requirements:
  5.4 - 6.0
• Meets J.P. Chemical Specifications:
  ≤0.3%
• Preserve in well-closed containers.:
  ≤0.4%
• Store in well-closed,light-resistant containers:
  ≤0.05%
• CAUTION: For Manufacturing, processing or repackaging:
  ≤0.03%
• Bulk Pharmaceutical Chemical:
  ≤0.003%
• USP - Assay (C₉H₁₁NO₂) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Specific Rotation [Å]²⁵ ^D (+):
  -34.7 - -32.7 Degree
• USP - pH:
  5.4 - 6.0
• USP - Loss on Drying at 105°C:
  ≤0.3 %
• 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 %
• EP/BP - Assay (C₉H₁₁NO₂) (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]²º^D (+):
  -35.5 - -33.0 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 %
• JP - Assay (C₉H₁₁NO₂) (dried basis):
  98.5 - 101.0 %
• JP - Identification:
  Passes Test
• JP - Optical Rotation (+):
  -35.5 - -33.0 Degree
• JP - pH:
  5.3 - 6.3
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Chloride (Cl):
  ≤0.021 %
• JP - Sulfate (SO₄):
  ≤0.028 %
• JP - Ammonium (NH₄):
  ≤0.02 %
• JP - Heavy Metals (as Pb):
  ≤20 ppm
• JP - Arsenic (As):
  ≤2 ppm
• JP - Related Substances:
  Passes Test
• JP - Loss on Drying at 105°C:
  ≤0.30 %
• JP - Residue on Ignition:
  ≤0.10 %