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

Supplier: AVANTOR PERFORMANCE MATERIAL LLC

MOC: Regulated

Certificates

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 PERFORMANCE MATERIAL LLC

MOC: Regulated

Certificates

About this item

Synonyms: (2R,3R,4R,5S)-Hexane-1,2,3,4,5,6-hexaol,(Sorbitol),D(-)-Glucitol

CAS Number:50-70-4

:98201-93-5

Formula:HOH₂C(CH(OH))₄CH₂OH

MW:182.17 g/mol

MDL Number:MFCD00004708

:Length:

:Width:

:Height:

:Ø

:Thickness:

:91,0-100,5

:Management of Change (MOC) category = R

:Boiling Pt:

:Melting Pt:

:Melting Pt: 94 to 98 °C

:Flash Pt:

:M.W. 182.17 g/mol

:D-(-)-Sorbitol

:295

:M.O.C. Category R

:12,08873

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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:
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.: