Specification Test Results

• GMP Manufactured Product:
• Meets U.S.P Requirements:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• Appearance (Colorless or translucent crystals or granules):
  Passes Test
• USP - Assay (Na₂HPO₄) (dried basis):
  98.0 - 100.5 %
• USP - Arsenic (As):
  ≤ 16 ppm
• USP - Chloride (Cl):
  ≤ 0.06 %
• USP - Endotoxin Concentration (EU/g):
  ≤ 2.5
• USP - Identification:
  Passes Test
• USP - Insoluble Substances:
  ≤ 0.4 %
• USP - Loss on Drying:
  43.0 - 50.0 %
• USP - Sulfate (SO₄):
  ≤ 0.2 %
• EP - Identification A:
  Passes Test
• EP - Identification C:
  Passes Test
• EP - Identification D:
  Passes Test
• EP - Reducing Substances:
  Passes Test
• EP - Monosodium Phosphate:
  ≤ 2.5 %
• EP - Chloride (Cl):
  ≤ 200 ppm
• EP - Sulfate (SO₄):
  ≤ 500 ppm
• EP - Appearance of Solution:
  Passes Test
• EP - Iron (Fe):
  ≤ 20 ppm
• EP - Assay (dried basis):
  98.0 - 101.0 %
• JP - Arsenic (As):
  ≤ 2 ppm
• JP - Assay (Na₂HPO₄) (dried basis):
  98.0 - 101.0 %
• JP - Carbonate (CO₃):
  Passes Test
• JP - Chloride (Cl):
  ≤ 0.014 %
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Heavy Metals:
  ≤ 10 ppm
• JP - Identification:
  Passes Test
• JP - pH (1 in 50):
  9.0 - 9.4
• JP - Sulfate (SO₄):
  ≤ 0.038 %
• No Class 1,2,3 or other solvents are used or produced in the:
• manufacturing or purification of the product.:
• The EP results are derived from testing Sodium Phosphate, Dibasic,:
• 7-Hydrate, U.S.P. to the EP chemical specifications derived from:
• Disodium Phosphate Dihydrate and Disodium Phosphate Dodecahydrate.:
• The JP results are derived from testing Sodium Phosphate, Dibasic,:
• 7-Hydrate, U.S.P. to the JP chemical specifications derived from Dibasic:
• Sodium Phosphate Hydrate.:
• 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.: