Specification Test Results

• Meets B.P. Chemical Specifications:
• Meets E.P. Chemical Specifications:
• GMP Manufactured Product:
• Meets J.P. Chemical Specifications:
• Store in airtight container.:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• EP/BP - Assay (C₆H₉N₃O₂·HCl) (dried basis):
  98.5 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Identification F:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - pH:
  3.0 - 5.0
• EP/BP - Specific Rotation [Å]²º^D (+):
  9.2 - 10.6 Degree
• EP/BP-Ninhydrin-Positive Substances-Each:
  ≤0.2 %
• EP/BP-Ninhydrin-Positive Substances-Total Impurities:
  ≤0.5 %
• EP/BP - Sulfate (SO₄):
  ≤300 ppm
• EP/BP - Ammonium (NH₄):
  ≤0.02 %
• EP/BP - Iron (Fe):
  ≤10 ppm
• EP/BP - Loss on Drying at 150°C:
  7.0 - 10.0 %
• EP/BP - Ash (sulfated):
  ≤0.1 %
• JP - Identification:
  Passes Test
• JP - Optical Rotation (+):
  9.2 - 10.6
• JP - pH:
  3.5 - 4.5
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Sulfate (SO₄):
  ≤0.028 %
• JP - Ammonium (NH₄):
  ≤0.02 %
• JP - Heavy Metals (as Pb):
  ≤10 ppm
• JP - Iron (Fe):
  ≤10 ppm
• JP - Related Substances:
  Passes Test
• JP - Water:
  7.2 - 10.0 %
• JP - Residue on Ignition:
  ≤0.10 %
• JP - Assay (anhydrous basis):
  99.0 - 101.0 %
• Endotoxin Concentration, IU/mg ,For Information Only:
• 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.: