Specification Test Results

• GMP Manufactured Product:
• Meets U.S.P Requirements:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• USP - Assay (as HOCH₂CHOHCH₂OH) (calculated on anhydrous basis):
  99.0 - 101.0 %
• 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 - 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 %
• 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.:
• J.T.Baker®, Glycerine (vegetable based) 99.0-101.0% (by anhydrous basis) USP: