D-(-)-Sorbitol 91,0-100,5 Anhydrous basis NF, multi-compendial
Supplier: Avantor
Synonyms:
(2R,3R,4R,5S)-Hexane-1,2,3,4,5,6-hexaol, (Sorbitol), D(-)-Glucitol, D-Sorbitol, Sorbitol
M.O.C. Category R
3449-B1EA
0
INR
3449-B1
3449-D1
3449-SD
D-(-)-Sorbitol 91,0-100,5 Anhydrous basis NF, multi-compendial
D(-)-Sorbitol
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 |
Specification Test Results
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets J.P. Chemical Specifications | |
| Meets N.F. Requirements | |
| 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. | |
| This product has been filled to +/- 1% of the stated net weight. |
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