Specification Test Results

• USP - Assay (C₄H₁₁NO₃):
  99.0 - 101.0 %
• USP - Identification A:
  Passes Test
• USP - Identification C:
  Passes Test
• USP - pH (1 in 20):
  10.0 - 11.5
• USP - Loss on Drying:
  ≤ 1.0 %
• USP - Residue on Ignition:
  ≤ 0.1 %
• USP - Melting Range(Lower):
  168 - 172 °C
• USP - Melting Range(Upper):
  168 - 172 °C
• EP/BP - Assay (C₄H₁₁NO₃) (dried basis):
  99.0 - 100.5 %
• EP/BP - Identification B (melting point):
  168 - 174 °C
• EP/BP - Identification C:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - pH:
  10.0 - 11.5
• EP/BP - Related Substances:
  ≤ 1.0 %
• EP/BP - Chloride (Cl):
  ≤ 100 ppm
• EP/BP - Iron (Fe):
  ≤ 10 ppm
• EP/BP - Loss on Drying at 105°C:
  ≤ 0.5 %
• EP/BP - Ash (sulfated):
  ≤ 0.1 %
• JPC 1997 - Assay (C₄H₁₁NO₃) (dried basis):
  ≥ 99.0 %
• JPC 1997 - Identification A:
  Passes Test
• JPC 1997 - Identification B:
  Passes Test
• JPC 1997 - pH:
  10.3 - 10.7
• JPC 1997 - Melting Point:
  168 - 172 °C
• JP - Clarity and Color of Solution:
  Passes Test
• JPC 1997 - Heavy Metals (as Pb):
  ≤ 8 ppm
• JPC 1997 - Arsenic (As):
  ≤ 1.6 ppm
• JPC 1997 - Loss on Drying:
  ≤ 0.5 %
• JPC 1997 - Residue on Ignition:
  ≤ 0.10 %