Specification Test Results

• Meets U.S.P Requirements:
• Meets J.P. Chemical Specifications:
• GMP Manufactured Product:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• USP - Assay (C₅H₁₀N₂O₃) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Specific Rotation [Å]²º^D (+):
  6.3 - 7.3 Degree
• USP - Loss on Drying at 105°C:
  ≤ 0.3 %
• USP - Residue after Ignition:
  ≤ 0.3 %
• USP - Chloride (Cl):
  ≤ 0.05 %
• USP - Sulfate (SO₄):
  ≤ 0.03 %
• USP - Iron (Fe):
  ≤ 0.003 %
• USP - Related Compounds:
  0.5% max
• JP - Assay (C₅H₁₀N₂O₃) (dried basis):
  99.0 - 101.0 %
• JP - Identification:
  Passes Test
• JP - Specific Rotation [Å]²º^D (+):
  6.3 - 7.3 Degree
• JP - Loss on Drying at 105°C:
  ≤ 0.30 %
• JP - Residue after Ignition:
  ≤ 0.1 %
• JP - Chloride (Cl):
  ≤ 0.021 %
• JP - Sulfate (SO₄):
  ≤ 0.028 %
• JP - Iron (Fe):
  ≤ 10 ppm
• JP - Heavy Metals (as Pb):
  ≤ 10 ppm
• JP - Related substances:
  Passes Test
• JP - pH:
  4.5 - 6.0
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Ammonium:
  ≤ 0.1 %
• Solubility of 3% Solution at 30°C:
  Passes Test
• Solubility of 3.5% Solution at 30°C:
  Passes Test
• Identification (by IR):
  Passes Test
• Endotoxin Concentration (EU/mg):
  ≤ 0.06
• Endotoxin Concentration, IU/mg:
  Passes Test
• 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®, L(+)-Glutamine 98.5-101.5% (dry basis) USP, Multi-Compendial: