Specification Test Results

• Appearance:
  Conforms (see CoA/CoS)
• Heavy metals (as Pb):
  Max. 5 ppm
• Residual solvents:
  Unlikely by manuf.process
• Metal catalysts:
  Unlikely by manuf.process
• As (Arsenic):
  Max. 2 ppm
• Cd (Cadmium):
  Max. 1 ppm
• Co (Cobalt):
  Max. 1 ppm
• Hg (Mercury):
  Max. 2 ppm
• Pb (Lead):
  Max. 3 ppm
• V (Vanadium):
  Max. 1 ppm
• Conforms to Ph.Eur./USP:
  Passes test
• Ph.Eur. specifications::
  Max. 2.0 %
• Assay (dried substance) [Ph.Eur.]:
  97.0 --> 102.0 %
• Identification C:
  Passes test Ph.Eur.
• Appearance of solution:
  Passes test Ph.Eur.
• Conductivity (20°C; 20 %) [Ph.Eur.]:
  Max. 20 μS/cm
• Melting point [Ph.Eur.]:
  165 --> 170 °C
• Reducing sugars (as C6H12O6) [Ph.Eur.]:
  Max. 0.1 %
• D-Sorbitol [Ph.Eur.]:
  Max. 2.0 %
• D-Maltitol and isomalt [Ph.Eur.]:
  Max. 2.0 %
• Unspecified impur. (for each) [Ph.Eur.]:
  Max. 0.10 %
• Total impurities [Ph.Eur.]:
  Max. 2.0 %
• Disregard limit [Ph.Eur.]:
  Max. 0.05 %
• Loss on drying (105°C; 4 h) [Ph.Eur.]:
  Max. 0.5 %
• TAMC [Ph.Eur.]:
  Max. 1000 CFU/g
• TYMC [Ph.Eur.]:
  Max. 100 CFU/g
• Escherichia coli [Ph.Eur.]:
  Absent
• Salmonella [Ph.Eur.]:
  Absent
• Assay (calculated on dried basis) [USP]:
  97.0 --> 102.0 %
• Identification A:
  Passes test USP
• Disregard limit [USP]:
  Max. 0.05 %
• Sorbitol [USP]:
  Max. 2.0 %
• Sum of isomalt and maltitol [USP]:
  Max. 2.0 %
• Unspecified impurities [USP]:
  Max. 0.10 %
• Total impurities [USP]:
  Max. 2.0 %
• Reducing sugars (as C6H12O6) [USP]:
  Max. 0.1 %
• Ni (Nickel) [USP]:
  Max. 1 μg/g
• Melting point [USP]:
  165 --> 170 °C
• Loss on drying (105°C; 4 h) [USP]:
  Max. 0.5 %
• Conductivity (25°C; 20 %) [USP]:
  Max. 20 μS/cm
• TAMC [USP]:
  Max. 1000 CFU/g
• TYMC [USP]:
  Max. 100 CFU/g
• Escherichia coli [USP]:
  Absent