Specification Test Results

• Acidity (USP):
  PASS
• Arsenic 211 (USP):
  ≤ 1 μg/g
• Endotoxins (USP):
  ≤ 2.5EU/g
• Chloride 221 (USP):
  ≤ 0.018%
• Color of Solution (USP):
  PASS
• Dextrin (USP):
  PASS
• Heavy Metals 231 (USP):
  ≤ 5μg/g
• Identification A (USP):
  PASS
• Residue on Ignition 281 (USP):
  ≤ 0.1%
• Soluble Starch, Sulfite (USP):
  PASS
• Specific Rotation 781S (USP):
  +52.6⁰ - +53.2⁰
• Sulfate 221 (USP):
  ≤ 0.025%
• Water Determination 921 (USP):
  ≤ 0.5%
• Appearance of Solution (EP & BP):
  PASS
• Assay (anhydrous substance) (EP & BP):
  97.5% - 102.0%
• Conductivity (2.2.38) (EP & BP):
  ≤ 20μS/cm
• Dextrin (EP & BP):
  PASS
• Identification A (Specific Optical Rotation) (EP & BP):
  +52.5⁰ - +53.3⁰
• Identification B (EP & BP):
  PASS
• Identification E (Water) (EP & BP):
  ≤ 1.0%
• Related Substances (Disregard Limit) (EP & BP):
  ≤ 0.05%
• Related Substances (Impurity C) (EP & BP):
  ≤ 0.2%
• Related Substances (Impurity D) (EP & BP):
  ≤ 0.15%
• Related Substances (Sum of Impurities A and B) (EP & BP):
  ≤ 0.4%
• Related Substances (Total) (EP & BP):
  ≤ 0.5%
• Related Substances (Unspecified Impurities) (EP & BP):
  ≤ 0.10%
• Soluble Starch, Sulfite (EP & BP):
  ≤ 15ppm
• Water (EP & BP):
  ≤ 1.0%
• Acidity (JP):
  PASS
• Arsenic 1.11 (JP):
  ≤ 1.3ppm
• Assay (dried) (JP):
  ≥ 99.5%
• Chloride 1.03 (JP):
  ≤ 0.018%
• Clarity and Color of Solution (JP):
  PASS
• Dextrin (JP) (JP):
  PASS
• Heavy Metals (JP):
  ≤ 4ppm
• Identification (JP):
  PASS
• Loss on Drying 2.41 (JP):
  ≤ 1.0%
• Residue on Ignition 2.44 (JP):
  ≤ 0.1
• Soluble Starch, Sulfite (JP):
  PASS
• Sulfate 1.14 (JP):
  ≤ 0.024%