Specification Test Results

• GMP Manufactured Product:
  —
• Meets B.P. Chemical Specifications:
  —
• Meets E.P. Chemical Specifications:
  —
• Food GMP Manufactured Product:
  —
• Meets U.S.P Requirements:
  —
• Meets F.C.C. Requirements:
  —
• CAUTION: For Manufacturing, processing or repackaging:
  —
• Bulk Pharmaceutical Chemical:
  —
• Bulk Food Chemical:
  —
• USP - Assay (dried basis):
  99.0 - 101.0 %
• USP - Identification A:
  Passes Test
• USP - Identification B:
  Passes Test
• USP - Identification C:
  Passes Test
• USP - pH (1 in 20):
  4.0 - 5.5
• USP - Loss on Drying (by wt):
  8.7 - 11.4 %
• USP - Calcium (Ca):
  Passes Test
• USP - Limit of Nitrilotriacetic Acid (by wt):
  ≤0.1 %
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Identification A:
  Passes Test
• EP/BP - Assay:
  98.5 - 101.0 %
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification D:
  Passes Test
• EP/BP - Impurity A and Related Substances - Impurity A:
  ≤0.1 %
• EP/BP - Iron (Fe):
  ≤80 ppm
• EP/BP - pH (1 in 20):
  4.0 - 5.5
• Endotoxin Concentration (EU/g):
  ≤5
• FCC - Assay (anhydrous basis):
  99.0 - 101.0 %
• FCC - Identification A:
  Passes Test
• FCC - Identification B:
  Passes Test
• FCC - Identification C:
  Passes Test
• FCC - Lead (Pb):
  ≤10 mg/kg
• FCC - pH (1 in 100):
  4.3 - 4.7
• FCC - Calcium (Ca):
  Passes Test
• FCC - Limit of Nitrilotriacetic Acid (by wt):
  ≤0.1 %