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D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial, J.T.Baker®
D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial, J.T.Baker®
Supplier:  Avantor
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D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial, J.T.Baker®
Supplier:  Avantor
Certificates

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Specification Test Results

  • Meets B.P. Chemical Specifications:
    —
  • Meets E.P. Chemical Specifications:
    —
  • Meets N.F. Requirements:
    —
  • GMP Manufactured Product:
    —
  • Meets J.P. Chemical Specifications:
    —
  • CAUTION: For Manufacturing, processing or repackaging:
    —
  • Bulk Pharmaceutical Chemical:
    91.0 - 100.5 %
  • NF - Assay (anhydrous basis):
    91.0 - 100.5 %
  • NF - Identification A:
    Passes Test
  • NF - Identification B:
    Passes Test
  • NF - pH of 10% solution:
    3.5 - 7.0
  • NF - Reducing Sugars:
    ≤ 0.3 %
  • NF - Residue on Ignition:
    ≤ 0.1 %
  • NF - Nickel (Ni):
    ≤ 1 ppm
  • NF - Chloride (Cl):
    ≤ 0.0050 %
  • NF - Sulfate (SO₄):
    ≤ 0.01 %
  • NF - Water:
    ≤ 1.5 %
  • NF - Total Aerobic Microbial Count, cfu/g:
    ≤ 1000
  • NF - Total Yeast and Mold Count, cfu/g:
    ≤ 100
  • EP/BP - Assay (anhydrous basis):
    97.0 - 102.0 %
  • EP/BP - Identification A:
    Passes Test
  • EP/BP - Appearance of Solution:
    Passes Test
  • EP/BP - Conductivity, uS cm-1:
    ≤ 20
  • EP/BP - Reducing Sugars:
    ≤ 0.2 %
  • EP/BP - Related Substances - Any impurity, each:
    ≤ 2.0 %
  • EP/BP - Related Substances - Total:
    ≤ 3.0 %
  • EP/BP - Water:
    ≤ 1.5 %
  • Total Viable Aerobic Count - Total Aerobic Microbial Count, cfu/g:
    ≤ 100
  • Total Viable Aerobic Count - Total Yeast and Mold Count, cfu/g:
    ≤ 100
  • Total Viable Aerobic Count - Escherichia coli (negative):
    Passes Test
  • Salmonella (negative):
    Passes Test
  • Endotoxin Concentration, <2.5 IU/g:
    Passes Test
  • JP - Assay (dried basis):
    ≥ 97.0 %
  • JP - Identification A:
    Passes Test
  • JP - Identification B:
    Passes Test
  • JP - Identification C:
    Passes Test
  • JP - Clarity and Color:
    Passes Test
  • JP - Acidity or Alkalinity:
    Passes Test
  • JP - Chloride (Cl):
    ≤ 0.005 %
  • JP - Sulfate (SO₄):
    ≤ 0.006 %
  • JP - Heavy Metals (as Pb):
    ≤ 5 ppm
  • JP - Nickel (Ni):
    Passes Test
  • JP - Arsenic (As):
    ≤ 1.3 ppm
  • JP - Glucose:
    Passes Test
  • JP - Sugars:
    Passes Test
  • JP - Loss on Drying:
    ≤ 2.0 %
  • JP - Residue on Ignition:
    ≤ 0.02 %

Specification Test Results

Related Information