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D-(+)-Galactose NF, Ph. Eur. for bioprocessing, suitable for use as excipient endotoxin tested
 
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D-(+)-Galactose NF, Ph. Eur. for bioprocessing, suitable for use as excipient endotoxin tested
 
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  • 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 %

 

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