Specification Test Results

• Assay (acidimetric; calculated on dried substance):
  99.0-100.5%
• Appearance of solution (5%, water):
  Passes test
• Arsenic (As):
  0.00002% max
• Chloride (Cl):
  0.001% max
• Colony count, aerobic bacteria:
  100CFU/g max
• Colony count, yeast and mold:
  100CFU/g max
• Endotoxins:
  0.03I.U./mg max
• Escherichia coli:
  Absent in 10 g
• Filtration test (0.45 µm):
  Conforms
• Heavy metals (as Pb):
  0.0010% max
• Identification A:
  Passes test
• Identification B:
  Passes test
• Identification C:
  Passes test
• Iron (Fe):
  0.0010% max
• Loss on drying (105°C):
  0.5% max
• Melting point:
  168-172°C
• Organic volatile impurities (USP/NF):
  Conforms
• Other Residual Solvents (Ph.Eur./ICH):
  Excluded by production process
• pH (5%, water):
  10.0-11.5
• pH of a 1% aqueous solution:
  10.3-10.7
• Pseudomonas Aeruginosa:
  Absent in 10 g
• Related substances (TLC):
  Conforms
• Residual solvents (Ph.Eur./ICH) class 3:
  0.5% max
• Salmonella:
  Absent in 10 g
• Staphylococcus Aureus:
  Absent in 10 g
• Sulfate (SO4):
  0.005% max
• Sulfated ash:
  0.1% max