Specification Test Results

• Assay (complexometric calculated as Magnesiumoxide):
  40.0 - 43.5 %
• Assay USP (alkalimetric calculated as Magnesiumoxide):
  40.0 - 43.5 %
• Assay JP (complexometric calculated as Mangesiumoxide):
  40.0 - 44.0 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• Substances soluble in water:
  ≤ 1.0 %
• soluble salts:
  ≤ 1.0 %
• Substances insoluble in acetic acid:
  ≤ 0.05 %
• Substances insoluble in acid:
  ≤ 0.05 %
• Chloride (Cl):
  ≤ 0.02 %
• Nitrate (NO₃):
  ≤ 0.015 %
• Nitrite (NO₂):
  ≤ 0.015 %
• Sulfate (SO₄):
  ≤ 0.3 %
• Heavy metals (as Pb):
  ≤ 0.001 %
• As (Arsenic):
  ≤ 0.0002 %
• Ca (Calcium):
  ≤ 0.4 %
• CaO (Calcium oxide):
  ≤ 0.6 %
• Fe (Iron):
  ≤ 0.005 %
• Hg (Mercury):
  ≤ 0.0001 %
• Na (Sodium):
  ≤ 0.4 %
• Pb (Lead):
  ≤ 0.0002 %
• Residual solvents (ICH Q3C):
  excluded by manufacturing process
• Bulk density:
  ≥ 0.25 g/ml
• Particle Size (d50):
  21 - 51 µm
• Particle Size (d90):
  41 - 91 µm
• Precipitation test:
  ≤ 12 ml
• Total aerobic microbial count:
  ≤ 2000 CFU/g
• Total yeast and mould count:
  ≤ 200 CFU/g
• E.coli (absent in 1 g):
  passes test