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D-(+)-Glucose, anhydrous, EMPROVE® EXPERT USP, ACS, Ph. Eur., BP, SAFC®
D-(+)-Glucose, anhydrous, EMPROVE® EXPERT USP, ACS, Ph. Eur., BP, SAFC®
Certificates
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D-(+)-Glucose, anhydrous, EMPROVE® EXPERT USP, ACS, Ph. Eur., BP, SAFC®
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Assay (calc. on anhydrous substance):
    97.5 - 102.0 %
  • Identity (IR):
    passes test
  • Identity (spec. rotation calc. on anhydrous substance):
    passes test
  • Identity (HPLC):
    passes test
  • Identity (water):
    passes test
  • Appearance of solution:
    passes test
  • Color and clarity of solution:
    passes test
  • Titrable acid:
    ≤ 0.002 meq/g
  • Conductivity:
    ≤ 20 µS/cm
  • Spec. rotation (α25/D):
    52.5 - 53.0 °
  • In water insoluble matter:
    ≤ 0.005 %
  • Chloride (Cl):
    ≤ 0.01 %
  • Sulfate (SO₄):
    ≤ 0.005 %
  • Heavy metals (as Pb):
    ≤ 5 ppm
  • Fe (Iron):
    ≤ 5 ppm
  • Related substances [sum of impurities A (maltose) and B (isomaltose)!:
    ≤ 0.4 %
  • Related substances [Impurity C (maltotriose)!:
    ≤ 0.2 %
  • Related substances [Impurity D (fructose)!:
    ≤ 0.15 %
  • Related substances (unspecified impurities):
    ≤ 0.10 %
  • Related substances (Sum of all impurities):
    ≤ 0.5 %
  • Dextrin:
    passes test
  • Soluble starch, sulfite:
    ≤ 15 ppm
  • Starch:
    passes test
  • Residual solvents (ICH Q3C):
    excluded by the manufacturing process
  • Loss on drying (105 °C):
    ≤ 0.2 %
  • Water (according to Karl Fischer):
    ≤ 1.0 %
  • Sulfated ash (600 °C):
    ≤ 0.02 %
  • Microbiological purity (Total aerobic microbial count (TAMC)):
    ≤ 100 CFU/g
  • Microbiological purity (Total yeast and mould count (TYMC)):
    ≤ 100 CFU/g
  • Bile tolerant Gram negative Bacteria (absent in 1 g):
    passes test
  • Escherichia coli (absent in 1 g):
    passes test
  • Pseudomonas aeruginosa (absent in 1 g):
    passes test
  • Staphylococcus aureus (absent in 1 g):
    passes test
  • Candida albicans (absent in 1 g):
    passes test
  • Salmonella ssp (absent in 10 g):
    passes test
  • Endotoxins:
    ≤ 10 I.U./g

Specification Test Results

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