Glycerin (Vegetable)
- 2143
- USP/EP/BP
- Glycerol, endotoxin tested, multi-compendial grade
- 56-81-5
- HOCH2CHOHCH2OH
- 92.1
-
- 199
- 01.26
|
01
500.00 ML
CAD $ 122.00 Each
03
4.00 L
CAD $ 598.00 Each
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Product Specifications
| GMP Manufactured Product |
|
| Meets U.S.P. Requirements |
|
| Identification |
Passes Test |
| Specific Gravity at 25°/25°C |
min. 1.249 |
| Color |
Passes Test |
| Residue on Ignition |
max. 0.01 % |
| Chloride (Cl) |
max. 0.001 % |
| Sulfate (SO4) |
max. 0.002 % |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Chlorinated Compounds (as Cl) |
max. 0.003 % |
| Fatty Acids and Esters(as butyric acid) |
Passes Test |
Assay (as HOCH2CHOHCH2OH) (calculated on anhydrous basis) |
99.0 - 101.0 % |
| Water (H2O) |
max. 5.0 % |
| Limit of Diethylene Glycol and Related Compounds: |
|
| Individual Impurity |
max. 0.1 % |
| Total Impurities |
max. 1.0 % |
| |
|
| Meets BP/Ph.Eur. Chemical Specifications |
|
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Appearance of Solution |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Refractive Index, n20D |
1.470 - 1.475 |
| Aldehydes |
max. 10 ppm |
| Ester |
Passes Test |
| Halogenated Compounds |
max. 35 ppm |
| Sugars |
Passes Test |
| Chloride (Cl) |
max. 10 ppm |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Water (H2O) |
max. 2.0 % |
| Ash (sulfated) |
max. 0.01 % |
| Impurity A and Related Substances: |
|
| Impurity A |
max. 0.1 % |
Other Impurities with RT
| max. 0.1 % |
|
| Total impurities RT>Glycerol |
max. 0.5 % |
| Assay (anhydrous basis) |
98.0 - 101.0 % |
| |
|
| Meets JP Chemical Specifications |
|
| Assay (anhydrous basis) |
98.0 - 101.0 % |
| Identification |
Passes Test |
| Specific Gravity at 20°/20°C |
min. 1.258 |
| Refractive Index, n20D |
min. 1.470 |
| Color |
Passes Test |
| Residue on Ignition |
max. 0.01 % |
| Chloride (Cl) |
max. 0.001 % |
| Sulfate (SO4) |
max. 0.002 % |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Fatty Acids and Esters(as butyric acid) |
Passes Test |
| Readily Carbonizable Substances |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
Acrolein, Glucose, and Related Compounds |
Passes Test |
| Ammonium (NH4) |
Passes Test |
| Calcium (Ca) |
Passes Test |
| Arsenic (As) |
max. 2 ppm |
| Water (H2O) |
max. 2.0 % |
| |
|
| Endotoxin Concentration (EU/g) |
max. 5 |
| |
|
| No Class 1, 2 or 3 Residual Solvents are likely to be present by exclusion of the production/purification process. |
|
| Bulk Pharmaceutical Chemical |
|
| CAUTION: For manufacturing, processing or repacking. |
|