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Update to Avantor’s response to the coronavirus (COVID-19) pandemic

D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial

Supplier: AVANTOR PERFORMANCE MATERIALS US
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Management of Change (MOC) category = R

3449-09 3449-06
JT3449-9EA 8616.25 USD InStock
JT3449-9 JT3449-06
D-(-)-Sorbitol 91.0-100.5% (by anhydrous basis) NF, Multi-Compendial
D(-)-Sorbitol
Sorbitol, Multi-Compendial.

Only class 2 solvents (ethylene glycol) are likely to be present. All are below option 1 limits.


Formula: HOH₂C(CH(OH))₄CH₂OH
MW: 182.17 g/mol
Boiling Pt: 295
 MDL Number: MFCD00004708
CAS Number: 50-70-4
Merck Index: 13,08797
https://qa.digitalassets.avantorsciences.com/adaptivemedia/rendition?id=f82054e8cfed2cf3e8b739c3cb816c4f91bd2735&vid=f82054e8cfed2cf3e8b739c3cb816c4f91bd2735&prid=web&clid=SAPDAM
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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.

 

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