D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Management of Change (MOC) category = R
3449-09EA
4379.65
EUR
3449-09
3449-W2
3449-68
3449-36
3449-39
3449-06
D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial, J.T.Baker®
D-(-)-Sorbitol
Only class 2 solvents (ethylene glycol) are likely to be present. All are below option 1 limits.
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 | |
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 % |
Only Class 2 solvents (Ethylene Glycol) are likely to be present. All are below Option 1 limits. |
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