Résultats des tests de spécification

• GMP Manufactured Product:
  —
• Meets B.P. Chemical Specifications:
  —
• Meets E.P. Chemical Specifications:
  —
• Meets J.P. Chemical Specifications:
  —
• Meets N.F. Requirements:
  —
• CAUTION: For Manufacturing, processing or repackaging:
  —
• Bulk Pharmaceutical Chemical:
  —
• NF - Assay (anhydrous basis):
  91.0 - 100.5 %
• NF - Identification A:
  Passes Test
• NF - Identification B:
  Passes Test
• NF - pH of 10% solution:
  3.5 - 7.0
• NF - Reducing Sugars:
  ≤ 0.3 %
• NF - Residue on Ignition:
  ≤ 0.1 %
• NF - Nickel (Ni):
  ≤ 1 ppm
• NF - Water:
  ≤ 1.5 %
• NF - Total Aerobic Microbial Count, cfu/g:
  ≤ 1000
• NF - Total Yeast and Mold Count, cfu/g:
  ≤ 100
• EP/BP - Assay (anhydrous basis):
  97.0 - 102.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Conductivity, uS cm-1:
  ≤ 20
• EP/BP - Reducing Sugars:
  ≤ 0.2 %
• EP/BP - Related Substances - Any impurity, each:
  ≤ 2 %
• EP/BP - Related Substances - Total:
  ≤ 3 %
• EP/BP - Lead (Pb):
  ≤ 0.5 ppm
• EP/BP - Nickel (Ni):
  ≤ 1 ppm
• EP/BP - Water:
  ≤ 1.5 %
• Total Viable Aerobic Count - Total Aerobic Microbial Count, cfu/g:
  ≤ 100
• Total Viable Aerobic Count - Total Yeast and Mold Count, cfu/g:
  ≤ 100
• Total Viable Aerobic Count - Escherichia coli (negative):
  Passes Test
• Salmonella (negative):
  Passes Test
• Endotoxin Concentration, 2.5 IU/g:
  Passes Test
• JP - Assay (dried basis):
  ≥ 97.0 %
• JP - Identification A:
  Passes Test
• JP - Identification B:
  Passes Test
• JP - Identification C:
  Passes Test
• JP - Clarity and Color:
  Passes Test
• JP - Acidity or Alkalinity:
  Passes Test
• JP - Chloride (Cl):
  ≤ 0.005 %
• JP - Sulfate (SO₄):
  ≤ 0.006 %
• JP - Heavy Metals (as Pb):
  ≤ 5 ppm
• JP - Nickel (Ni):
  Passes Test
• JP - Arsenic (As):
  ≤ 1.3 ppm
• JP - Glucose:
  Passes Test
• JP - Sugars:
  Passes Test
• JP - Loss on Drying:
  ≤ 2.0 %
• JP - Residue on Ignition:
  ≤ 0.02 %