D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial, J.T.Baker®
: Avantor
: (2R,3R,4R,5S)-Hexane-1,2,3,4,5,6-hexaol, (Sorbitol), D(-)-Glucitol, D-Sorbitol, Sorbitol
:50-70-4
:98201-93-5
:HOH₂C(CH(OH))₄CH₂OH
:MFCD00004708
:295
:182.17 g/mol
:13,08797
:Management of Change (MOC) category = R
- Environmentally Preferable:
- 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 %
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