Specification Test Results

• Assay (USP):
  99.0 – 101.0%
• Endotoxins (USP):
  ≤ 2.5EU/g
• Heavy Metals 231 (USP):
  ≤10 ppm
• Identification A (USP):
  PASS
• Identification B (USP):
  PASS
• Identification C (USP):
  PASS
• Loss on Drying 731 (USP):
  ≤ 1.0%
• Melting range or temperature (USP):
  168⁰ - 172⁰C
• pH 791 (USP):
  10.0 – 11.5
• Residue on Ignition (USP):
  ≤ 0.1%
• Appearance of Solution (EP & BP):
  PASS
• Assay (EP & BP):
  99.0 – 100.5%
• Chlorides (2.4.4) (EP & BP):
  ≤100 ppm
• Heavy Metals (2.4.8) (EP & BP):
  ≤10 ppm
• Identification B (EP & BP):
  PASS
• Identification C (EP & BP):
  PASS
• Iron (2.4.9) (EP & BP):
  ≤10 ppm
• Loss on Drying (2.2.32) (EP & BP):
  ≤0.5%
• pH (2.2.3) (EP & BP):
  10.0 – 11.5
• Related Substances (2.2.27) (EP & BP):
  ≤1.0%
• Sulfated Ash (2.4.14) (EP & BP):
  ≤0.1%
• Arsenic (JPC):
  ≤1.6 ppm
• Assay (JPC):
  ≥99.0%
• Clarity and Color of Solution (JPC):
  PASS
• Heavy Metals (JPC):
  ≤8 ppm
• Identification (1)(JPC):
  PASS
• Identification (2)(JPC):
  PASS
• Loss on Drying (JPC):
  ≤0.5%
• Melting Point (JPC):
  168⁰C - 172⁰C
• pH (1.0g/100mL water)@25⁰C (JPC):
  10.3 – 10.7
• Residue on Ignition (JPC):
  ≤0.10%