Specification Test Results

• Meets F.C.C. Requirements:
• GMP Manufactured Product:
• Food GMP Manufactured Product:
• Meets U.S.P Requirements:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Food Chemical:
• Bulk Pharmaceutical Chemical:
• USP - Assay (C₂H₅NO₂) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Loss on Drying:
  ≤0.2 %
• USP - Residue on Ignition:
  ≤0.1 %
• USP - Chloride (Cl):
  ≤0.007 %
• USP - Sulfate (SO₄):
  ≤0.0065 %
• USP - Hydrolyzable Substances:
  Passes Test
• USP - Related Compounds: Glycine anhydride:
  ≤0.1 %
• USP - Related Compounds: Monochloroacetic acid (For Information Only):
• USP - Related Compounds: Iminodiacetic acid:
  ≤0.1 %
• USP - Related Compounds: Diglycine:
  ≤0.1 %
• USP - Related Compounds: Triglycine:
  ≤0.1 %
• USP - Related Compounds: Hexamethylenetetramine:
  ≤0.1 %
• USP - Related Compounds: Any unspecified impurity (For Information Only):
• USP - Related Compounds: Total impurities:
  ≤1.0 %
• FCC - Assay (C₂H₅NO₂) (dried basis):
  98.5 - 101.5 %
• FCC - Identification:
  Passes Test
• FCC - Lead (Pb):
  ≤5 mg/kg
• FCC - Loss on Drying:
  ≤0.2 %
• FCC - Residue on Ignition:
  ≤0.1 %
• FCC - Insoluble Foreign Matter:
  Passes Test
• Only Class 2 Solvents (Methanol) are likely to be present. All are:
• below Option 1 limits.:
• 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®, Glycine 98.5-101.5% FCC, USP: