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D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®
D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®
Supplier:  Avantor
Certificates
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D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®
Supplier:  Avantor
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Residual Methanol:
    ≤ 3000 ppm
  • Residual Ethanol:
    ≤ 5000 ppm
  • Residual Isopropanol:
    ≤ 5000 ppm
  • CAUTION: For Manufacturing, processing or repackaging:
    Passes Test
  • Bulk Pharmaceutical Chemical:
    Passes Test
  • NF - Assay (C6H12O6 ) (anhydrous basis):
    98.0 - 102.0 %
  • NF - Appearance of Solution:
    Passes Test
  • NF - Acidity:
    Passes Test
  • NF - Identification A (IR):
    Passes Test
  • NF - Identification B (HPLC):
    Passes Test
  • NF - Identification C:
    Passes Test
  • NF - Optical Rotation [Å]²ºD (+):
    78.0 - 81.5 Degree
  • NF - Related Substances: Lactose and 1,6-galactosylgalactose:
    ≤ 0.6 %
  • NF - Related Substances: Galacturonic acid:
    ≤ 0.6 %
  • NF - Related Substances: Dextrose:
    ≤ 0.6 %
  • NF - Related Substances: Tagatose:
    ≤ 0.6 %
  • NF - Related Substances: Dulcitol:
    ≤ 0.6 %
  • NF - Related Substances: Arabinose:
    ≤ 0.6 %
  • NF - Related Substances: Any unspecified impurity, each:
    ≤ 0.2 %
  • NF - Related Substances: Total impurities:
    ≤ 1.0 %
  • NF - Barium (Ba):
    Passes Test
  • NF - Lead (Pb):
    ≤ 0.5 ppm
  • NF - Water (H₂O):
    ≤ 1.0 %
  • NF - Residue on Ignition:
    ≤ 0.1 %
  • EP/BP - Assay (C₆H₁₂O₆)(anhydrous basis):
    97.0 - 102.0 %
  • EP/BP - Appearance of Solution:
    Passes Test
  • EP/BP - Acidity or Alkalinity:
    Passes Test
  • EP/BP - Identification A (IR):
    Passes Test
  • EP/BP - Proteins:
    ≤ 0.1 %
  • EP/BP - Related Substances: Sum of Impurities A and B:
    ≤ 1.0 %
  • EP/BP - Related Substances:Unspecified impurities, each:
    ≤ 0.3 %
  • EP/BP - Related Substances:Total impurities:
    ≤ 2.0 %
  • EP/BP - Specific Optical Rotation [Å]²ºD (+):
    78.0 - 81.5 Degree
  • EP/BP - Water (H₂O):
    ≤ 1.0 %
  • EP/BP - Sulfated Ash:
    ≤ 0.1 %
  • EP/BP - TAMC (cfu/g):
    ≤ 100 cfu/g
  • Appearance:
    Passes Test
  • Endotoxin Concentration (EU/g):
    ≤ 2.5
  • Glucose:
    ≤ 0.1 %
  • Purity (HPLC):
    ≥ 99 %
  • Residue on Ignition:
    ≤ 0.05 %
  • Microbial Testing - Salmonella (USP):
    None Detected
  • Microbial Testing - E. coli (USP):
    None Detected
  • Microbial Testing - Staphylococcus aureus (USP):
    None Detected
  • Microbial Testing - Pseudomonas aeruginosa (USP):
    None Detected
  • Microbial Testing - Total Yeast and Mold (USP):
    ≤ 100 cfu/g
  • Microbial Testing - Total Aerobic Microbial Count (USP):
    ≤ 100 cfu/g
  • Solution Clarity (300 mg/mL):
    Passes Test
  • Solution Color, APHA - For Information Only:
    For Information Only
  • Trace Impurities - Aluminum (Al), For Information Only:
    For Information Only
  • Trace Impurities - Arsenic (As), For Information Only:
    For Information Only
  • Trace Impurities - Cadmium (Cd), For Information Only:
    For Information Only
  • Trace Impurities - Chromium (Cr), For Information Only:
    For Information Only
  • Trace Impurities - Copper (Cu), For Information Only:
    For Information Only
  • Trace Impurities - Iridium (Ir), For Information Only:
    For Information Only
  • Trace Impurities - Iron (Fe), For Information Only:
    For Information Only
  • Trace Impurities - Lead (Pb), For Information Only:
    For Information Only
  • Trace Impurities - Manganese (Mn), For Information Only:
    For Information Only
  • Trace Impurities - Mercury (Hg), For Information Only:
    = 3000 ppm
  • Trace Impurities - Molybdenum (Mo), For Information Only:
    = 5000 ppm
  • Trace Impurities - Nickel (Ni), For Information Only:
    = 5000 ppm

Specification Test Results

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