Specification Test Results

• GMP Manufactured Product:
• Meets U.S.P Requirements:
• Meets B.P. Chemical Specifications:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• Appearance (White crystals or granules):
  Passes Test
• USP - Assay (anhydrous basis):
  98.0 - 103.0 %
• USP - Aluminum, Calcium, and Related Elements:
  Passes Test
• USP - Arsenic (As):
  ≤ 8 ppm
• USP - Chloride (Cl):
  ≤ 0.014 %
• USP - Identification A:
  Passes Test
• USP - Identification B:
  Passes Test
• USP - Insoluble Substances:
  ≤ 0.2 %
• USP - pH (1 in 20):
  4.1 - 4.5
• USP - Sulfate (SO₄):
  ≤ 0.15 %
• USP - Water (H₂O):
  10.0 - 15.0 %
• EP - Identification A:
  Passes Test
• EP - Identification B:
  Passes Test
• EP - Identification C:
  Passes Test
• EP - Assay (anhydrous basis):
  98.0 - 100.5 %
• EP - Chloride (Cl):
  ≤ 200 ppm
• EP - Sulfate (SO₄):
  ≤ 300 ppm
• EP - Reducing Substances:
  Passes Test
• Endotoxin Concentration (EU/g):
  ≤ 2.5
• EP - Iron (Fe):
  ≤ 10 ppm
• EP - Appearance of Solution:
  Passes Test
• EP - pH:
  4.2 - 4.5
• BP - Identification A:
  Passes Test
• BP - Identification B:
  Passes Test
• BP - Identification C:
  Passes Test
• BP - Identification D:
  Passes Test
• BP - Acidity:
  4.2 - 4.5
• BP - Clarity and Color of Solution:
  Passes Test
• BP - Arsenic (As):
  ≤ 2 ppm
• BP - Iron (Fe):
  ≤ 10 ppm
• BP - Chloride (Cl):
  ≤ 200 ppm
• BP - Sulfate (SO₄):
  ≤ 300 ppm
• BP - Reducing Substances:
  Passes Test
• BP - Loss on Drying at 130°C:
  11.5 - 14.5 %
• BP - Assay (dried basis):
  98.0 - 100.5 %
• JPE - Assay (dried basis):
  ≥ 98.0 %
• JPE - Identification:
  Passes Test
• JPE - pH:
  4.1 - 4.7
• JPE - Clarity and Color of Solution:
  Passes Test
• JPE - Chloride (Cl):
  ≤ 0.005 %
• JPE - Sulfate (SO4):
  ≤ 0.019 %
• JPE - Heavy Metals:
  ≤ 10 ppm
• JPE - Arsenic (As):
  ≤ 2 ppm
• For EP notated requirements, results are derived from testing Sodium:
• Phosphate, Monobasic Monohydrate, U.S.P. to the EP Chemical:
• specifications for Sodium Dihydrogen Phosphate Dihydrate.:
• For JPE notated requirements, results are derived from testing Sodium:
• Phosphate, Monobasic Monohydrate, U.S.P. to the JPE Chemical:
• 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.: