Specification Test Results

• Appearance:
  Conforms (see CoA/CoS)
• Bacterial endotoxins:
  Max. 10 EU/g
• Residual solvents:
  Passes test
• Conforms to Ph.Eur./NF:
  Passes test
• Assay (calculated on anhydrous)[Ph.Eur.]:
  97.0 - 102.0 %
• Identification A:
  Passes test Ph.Eur.
• Appearance of solution:
  Passes test Ph.Eur.
• Acidity or alkalinity:
  Passes test Ph.Eur.
• Proteins [Ph.Eur.]:
  ≤ 0.1 mg/ml
• Related substances:
  Passes test Ph.Eur.
• Sum of impurties A and B [Ph.Eur.]:
  ≤ 1.0 %
• Unspecified impurities [Ph.Eur.]:
  ≤ 0.3 %
• Total impurities [Ph.Eur.]:
  ≤ 2.0 %
• Reporting threshold [Ph.Eur.]:
  ≤ 0.2 %
• Water [Ph.Eur.]:
  ≤ 1.0 %
• Sulphated ash [Ph.Eur.]:
  ≤ 0.1 %
• Microbial contamination (TAMC) [Ph.Eur.]:
  Max. 10² CFU/g
• Assay (calculated on anhydrous) [NF]:
  98.0 - 102.0 %
• Identification B:
  Passes test NF
• Identification C:
  Passes test NF
• Lactose and 1,6-galactosylgalactose [NF]:
  ≤ 0.6 %
• Galacturonic acid [NF]:
  ≤ 0.6 %
• Dextrose [NF]:
  ≤ 0.6 %
• Tagatose [NF]:
  ≤ 0.6 %
• Dulcitol [NF]:
  ≤ 0.6 %
• Arabinose [NF]:
  ≤ 0.6 %
• Any unspecified impurity [NF]:
  ≤ 0.2 %
• Total impurities [NF]:
  ≤ 1.0 %
• Residue on ignition [NF]:
  ≤ 0.1 %
• Limit of lead [NF]:
  ≤ 0.5 μg/g
• Ba (Barium):
  Passes test NF
• Microbial enumeration (TAMC) [NF]:
  Max. 10³ CFU/g
• Microbial enumeration (TYMC) [NF]:
  Max. 10² CFU/g
• Salmonella [NF]:
  Absent
• Escherichia coli [NF]:
  Absent
• Staphylococcus aureus [NF]:
  Absent
• Pseudomonas aeruginosa [NF]:
  Absent
• Spec.opt.rot.(20°C)(on anhydrous) [NF]:
  78.0 - 81.5 °
• Acidity:
  Passes test NF
• Water determination [NF]:
  ≤ 1.0 %