Specification Test Results

• Residual Methanol:
  ≤ 3000 ppm
• Residual Ethanol:
  ≤ 5000 ppm
• Residual Isopropanol:
  ≤ 5000 ppm
• NF - Assay (C6H12O6 ) (anhydrous basis):
  98.0 - 102.0 %
• NF - Appearance of Solution:
  Passes Test
• NF - Acidity:
  Passes Test
• NF - Identification A (IR):
  Passes Test
• NF - Identification B (HPLC):
  Passes Test
• NF - Identification C:
  Passes Test
• NF - Optical Rotation [Å]²ºD (+):
  78.0 - 81.5 Degree
• NF - Related Substances: Lactose and 1,6-galactosylgalactose:
  ≤ 0.6 %
• NF - Related Substances: Galacturonic acid:
  ≤ 0.6 %
• NF - Related Substances: Dextrose:
  ≤ 0.6 %
• NF - Related Substances: Tagatose:
  ≤ 0.6 %
• NF - Related Substances: Dulcitol:
  ≤ 0.6 %
• NF - Related Substances: Arabinose:
  ≤ 0.6 %
• NF - Related Substances: Any unspecified impurity, each:
  ≤ 0.2 %
• NF - Related Substances: Total impurities:
  ≤ 1.0 %
• NF - Barium (Ba):
  Passes Test
• NF - Lead (Pb):
  ≤ 0.5 ppm
• NF - Water (H₂O):
  ≤ 1.0 %
• NF - Residue on Ignition:
  ≤ 0.1 %
• EP/BP - Assay (C₆H₁₂O₆)(anhydrous basis):
  97.0 - 102.0 %
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Acidity or Alkalinity:
  Passes Test
• EP/BP - Identification A (IR):
  Passes Test
• EP/BP - Proteins:
  ≤ 0.1 %
• EP/BP - Related Substances: Sum of Impurities A and B:
  ≤ 1.0 %
• EP/BP - Related Substances:Unspecified impurities, each:
  ≤ 0.3 %
• EP/BP - Related Substances:Total impurities:
  ≤ 2.0 %
• EP/BP - Specific Optical Rotation [Å]²ºD (+):
  78.0 - 81.5 Degree
• EP/BP - Water (H₂O):
  ≤ 1.0 %
• EP/BP - Sulfated Ash:
  ≤ 0.1 %
• EP/BP - TAMC (cfu/g):
  ≤ 100 cfu/g
• Appearance:
  Passes Test
• Endotoxin Concentration (EU/g):
  ≤ 2.5
• Glucose:
  ≤ 0.1 %
• Purity (HPLC):
  ≥ 99 %
• Residue on Ignition:
  ≤ 0.05 %
• Microbial Testing - Salmonella (USP):
  None Detected
• Microbial Testing - E. coli (USP):
  None Detected
• Microbial Testing - Staphylococcus aureus (USP):
  None Detected
• Microbial Testing - Pseudomonas aeruginosa (USP):
  None Detected
• Microbial Testing - Total Yeast and Mold (USP):
  ≤ 100 cfu/g
• Microbial Testing - Total Aerobic Microbial Count (USP):
  ≤ 100 cfu/g
• Solution Clarity (300 mg/mL):
  Passes Test