Specification Test Results

• Food GMP Manufactured Product:
  98.5 - 101.5%
• GMP Manufactured Product:
  Passes Test
• Meets B.P. Chemical Specifications:
  -29.1 - -26.7 Degree
• Meets E.P. Chemical Specifications:
  5.0 - 6.5
• Meets J.P. Chemical Specifications:
  ≤0.2%
• Meets U.S.P Requirements:
  ≤0.4%
• Preserve in well-closed containers.:
  ≤0.05%
• Store in well-closed,light-resistant containers:
  ≤0.03%
• CAUTION: For Manufacturing, processing or repackaging:
  ≤0.003%
• Bulk Food Chemical:
  ≤0.5%
• Bulk Pharmaceutical Chemical:
  ≤2.0%
• USP - Assay (C₄H₈NO₃) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Specific Rotation α²⁵D:
  -29.1 - -26.7 Degree
• USP - pH:
  5.0 - 6.5
• 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 %
• EP/BP - Assay (C₄H₈NO₃) (dried basis):
  99.0 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - pH:
  5.0 - 6.5
• EP/BP - Specific Rotationα²ºD:
  -29.0 - -27.6 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 (C₄H₈NO₃) (dried basis):
  98.5 - 101.0 %
• JP - Identification:
  Passes Test
• JP - Optical Rotation:
  -29.0 - -26.0 Degree
• JP - pH:
  5.2 - 6.2
• 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:
  ≤ 0.20 %
• JP - Residue on Ignition:
  ≤ 0.10 %