Specification Test Results

• Assay (Acidimetric, NaOH):
  0.99 - 1.01 mol/l
• Carbonate (as Na₂CO₃):
  ≤1.0%
• Chloride (Cl):
  ≤5 ppm
• Sulfate (SO₄):
  ≤30 ppm
• Heavy Metals (as Pb):
  ≤5.0 ppm
• Al (Aluminium):
  ≤10 ppm
• Fe (Iron):
  ≤3 ppm
• Residual Solvents (ICH Q3C):
  Excluded by Production Process
• Endotoxins:
  ≤2.0 I.U./ml
• Total Aerobic Microbial Count (TAMC):
  ≤100 CFU/g
• Total Combined Yeasts/Moulds Count (TYMC):
  ≤10 CFU/g