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Glycerine (vegetable based) 99.0-101.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIALS

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2143-01EA 13792.94 INR InStock
2143-01 2143-03 2143-07 2143-09 2143-30
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


Formula: HOCH₂CH(OH)CH₂OH
MW: 92.09 g/mol
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
https://qa.digitalassets.avantorsciences.com/adaptivemedia/rendition?id=3668cce85af1464db21fd098526252076b567956&vid=481dd90ecbdec73cd4020432d3356161ebfe7681&prid=web&clid=SAPDAM
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Specification Test Results
Meets J.P. Chemical Specifications Passes Test
GMP Manufactured Product ≤0.10%
Meets U.S.P Requirements ≤0.10%
Meets B.P. Chemical Specifications Passes Test
Meets E.P. Chemical Specifications 99.0 - 101.0%
CAUTION: For Manufacturing, processing or repackaging ≥1.249
Bulk Pharmaceutical Chemical Passes Test
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 %
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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