Glycerine (vegetable based) 99.0-101.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Management of Change (MOC) category = R
2143-01
2143-09
2143-03
2143-07
JT2143-1CS
3655.97
USD
JT2143-1
JT2143-9
JT2143-3
JT2143-7
JT2143-30
Glycerine (vegetable based) 99.0-101.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®
Glycerine
Avantor excipients are used during the formulation process in a wide range of applications. Avantor provides high-purity and performance excipients that serve as fillers, binders, disintegrants, lubicants, flavors, emulsifiers and preservatives.
- GMP manufactured product
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Formula:
HOCH₂CH(OH)CH₂OH Boiling Pt: 290 °C (1013 hPa) Melting Pt: 18.6 °C Density: 1.26 g/cm³ (20 °C) Flash Pt: 177 °C Storage Temperature: Ambient |
MDL Number:
MFCD00004722 CAS Number: 56-81-5 EINECS: 200-289-5 Merck Index: 13,04497 |
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Specification Test Results
| Meets J.P. Chemical Specifications | |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification A | Passes Test |
| USP - Identification B - Diethylene Glycol | ≤0.10 % |
| USP - Identification B - Ethylene Glycol | ≤0.10 % |
| USP - Identification C | Passes Test |
| USP - Assay (as HOCH₂CHOHCH₂OH) (calculated on anhydrous basis) | 99.0 - 101.0 % |
| USP - Specific Gravity at 25°/25°C | ≥1.249 |
| USP - Color | Passes Test |
| USP - Residue on Ignition | ≤0.01 % |
| USP - Chloride (Cl) | ≤0.001 % |
| USP - Sulfate (SO₄) | ≤0.002 % |
| USP - Chlorinated Compounds (as Cl) | ≤0.003 % |
| USP - Fatty Acids and Esters | Passes Test |
| USP - Water (H₂O) | ≤5.0 % |
| USP - Related Compounds: Individual Impurity | ≤0.1 % |
| USP - Related Compo unds: Total Impurities | ≤1.0 % |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Refractive Index, n²ºD | 1.470 - 1.475 |
| EP/BP - Aldehydes | ≤10 ppm |
| EP/BP - Ester | Passes Test |
| EP/BP - Halogenated Compounds | ≤35 ppm |
| EP/BP - Sugars | Passes Test |
| EP/BP - Chloride (Cl) | ≤10 ppm |
| EP/BP - Water (H₂O) | ≤2.0 % |
| EP/BP - Ash (sulfated) | ≤0.01 % |
| EP/BP - Impurity A and Related Substances - Impurity A | ≤0.1 % |
EP/BP - Impurity A and Related Substances - Other Impurities with R^T|
≤0.1 % |
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| EP/BP - Impurity A and Related Substances - Total Impurities R^T>Glycerol | ≤0.5 % |
| EP - Assay (anhydrous basis) | 98.0 - 101.0 % |
| JP - Assay (anhydrous basis) | 98.0 - 101.0 % |
| JP - Identification | Passes Test |
| JP - Specific Gravity at 20°/20°C | ≥1.258 |
| JP - Refractive Index, n²ºD | ≥1.470 |
| JP - Color | Passes Test |
| JP - Residue on Ignition | ≤0.01 % |
| JP - Chloride (Cl) | ≤0.001 % |
| JP - Sulfate (SO₄) | ≤0.002 % |
| JP - Heavy Metals (as Pb) | ≤5 ppm |
| JP - Fatty Acids and Esters(as butyric acid) | Passes Test |
| JP - Readily Carbonizable Substances | Passes Test |
| JP - Acidity or Alkalinity | Passes Test |
| JP - Acrolein, Glucose, and Other Reducing Substances | Passes Test |
| JP - Ammonium (NH₄) | Passes Test |
| JP - Calcium (Ca) | Passes Test |
| JP - Arsenic (As) | ≤2 ppm |
| JP - Water (H₂O) | ≤2.0 % |
| JP - Ethylene Glycol | ≤0.1 % |
| JP - Diethylene Glycol | ≤0.1 % |
| JP - Any Other Impurity | ≤0.1 % |
| JP - Total Impurities | ≤1.0 % |
| Endotoxin Concentration (EU/g) | ≤5 |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
| impurities for this product is available on the associated Product | |
| Regulatory Data Sheet and elemental impurity profile report. |
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