Specification Test Results

• Assay (HPLC, Calc.on anhydrous substance):
  97.0 - 102.0%
• Identity (HPLC):
  Conforms
• Identity (IR-spectrum):
  Conforms
• Absorption ratio (A₂₅₆/A₃₆₅):
  2.80 - 3.00
• Spec. rotation (α 20/D; 10 g/l; NaOH 0,1 mol/l; calc. on anhydrous subst.):
  +18 - +22°
• Related substances (HPLC) (N-(4-aminobenzoyl)-L-glutamic acid (impurity A)):
  ≤0.5%
• Related substances (HPLC) (Pteroic Acid (Impurity D)):
  ≤0.6%
• Related Compounds (HPLC) (Total unspecified impurities):
  ≤1.0%
• Water (According to Karl Fischer):
  5.0 - 8.5%