Specification Test Results

• Meets F.C.C. Requirements:
• GMP Manufactured Product:
• Meets E.P. Chemical Specifications:
• Meets N.F. Requirements:
• Food GMP Manufactured Product:
• Meets J.P. Chemical Specifications:
• Meets B.P. Chemical Specifications:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• Bulk Food Chemical:
• NF - Total Alkali:
  95.0 - 100.5 %
• NF - Content of Sodium:
  54.0 - 59.8 %
• NF - Insoluble Substances and Organic Matter:
  Passes Test
• NF - Identification A (Sodium):
  Passes Test
• NF - Identification B (pH):
  ≥11.0
• NF - Potassium (K):
  ≤0.5 %
• NF/FCC - Carbonate (as Na₂CO₃):
  ≤3.0 %
• FCC - Assay (Total alkali as NaOH):
  95.0 - 100.5 %
• FCC - Lead (Pb):
  ≤2 mg/kg
• FCC - Mercury (Hg)(mg/kg):
  ≤0.1
• FCC - Arsenic (As)(mg/kg):
  ≤3
• FCC - Identification:
  Passes Test
• FCC - Insoluble Substances and Organic Matter:
  Passes Test
• BP/EP - Assay (Total alkali as NaOH):
  97.0 - 100.5 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Iron (Fe):
  ≤10 ppm
• EP/BP - Carbonate (as Na₂CO₃):
  ≤2.0 %
• EP/BP - Chloride (Cl):
  ≤200 ppm
• EP/BP - Sulfate (SO₄):
  ≤200 ppm
• JP - Assay:
  95.0 - 101.0 %
• JP - Identification A:
  Passes Test
• JP - Identification B:
  Passes Test
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Chloride (Cl):
  ≤0.050 %
• JP - Heavy Metals (as Pb):
  ≤30 ppm
• JP - Potassium (K):
  Passes Test
• JP - Carbonate (as Na₂CO₃):
  ≤2.0 %
• JP - Mercury (Hg):
  Passes Test
• Endotoxin Concentration (EU/g):
  ≤5
• Appearance (white hygroscopic pellets):
• 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.: