Specification Test Results

• 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.:
• Meets JPE Specifications:
• GMP Manufactured Product:
• Meets U.S.P Requirements:
• Meets E.P. Chemical Specifications:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• USP - Assay (Na₂HPO₄) (dried basis):
  98.0 - 100.5 %
• USP - Identification:
  Passes Test
• USP - Loss on Drying at 130°C:
  ≤ 5.0 %
• USP - Insoluble Substances:
  ≤ 0.4 %
• USP - Chloride (Cl):
  ≤ 0.06 %
• USP - Sulfate (SO₄):
  ≤ 0.2 %
• USP - Arsenic (As):
  ≤ 16 ppm
• JPE - Assay (dried basis):
  ≥ 99.0 %
• JPE - Arsenic (As):
  ≤ 2 ppm
• JPE - Carbonate:
  Passes Test
• JPE - Chloride (Cl):
  ≤ 0.011 %
• JPE - Clarity and Color of Solution:
  Passes Test
• JPE - Heavy Metals:
  ≤ 10 ppm
• JPE - pH (1-100):
  9.0 - 9.4
• JPE - Sulfate (SO₄):
  ≤ 0.038 %
• JPE - Loss on Drying:
  ≤ 2.0 %
• EP - Assay (Na₂HPO₄) (dried basis):
  98.0 - 101.0 %
• EP - Appearance of Solution:
  Passes Test
• EP - Identification A:
  Passes Test
• EP - Identification B:
  Passes Test
• EP - Identification C:
  Passes Test
• EP - Identification D:
  Passes Test
• EP - Reducing Substances:
  Passes Test
• EP - Chloride (Cl):
  ≤ 200 ppm
• EP - Iron (Fe):
  ≤ 20 ppm
• EP - Loss on Drying:
  ≤ 1.0 %
• EP - Monosodium Phosphate:
  ≤ 2.5 %
• EP - Sulfate (SO₄):
  ≤ 500 ppm
• Endotoxin Concentration (EU/g):
  ≤ 2.5
• Microbial Testing – Total Aerobic Microbial Count (USP):
  ≤ 10 cfu/g
• Microbial Testing – Total Yeast and Mold Count (USP):
  ≤ 10 cfu/g
• Microbial Testing - Salmonella (USP):
  Negative
• Microbial Testing - Escherichia coli (USP):
  Negative
• Microbial Testing - Staphylococcus aureus (USP):
  Negative
• Microbial Testing - Pseudomonas aeruginosa (USP):
  Negative
• Microbial Testing -Bile tolerant gram-negative bacteria:
  Negative
• Microbial Testing – Clostridia:
  Negative
• Microbial Testing - Candida albicans:
  Negative
• Trace Impurities - Cadmium (Cd):
  ≤ 200 ppb
• Trace Impurities - Lead (Pb):
  ≤ 500 ppb
• Trace Impurities - Arsenic (As):
  ≤ 1500 ppb
• Trace Impurities - Mercury (Hg):
  ≤ 300 ppb
• Trace Impurities - Cobalt (Co):
  ≤ 500 ppb
• Trace Impurities - Vanadium (V):
  ≤ 1000 ppb
• Trace Impurities - Nickel (Ni):
  ≤ 2000 ppb
• Trace Impurities - Thallium (Tl):
  ≤ 800 ppb
• Trace Impurities - Gold (Au):
  ≤ 10000 ppb
• Trace Impurities - Palladium (Pd):
  ≤ 1000 ppb
• Trace Impurities - Iridium (Ir):
  ≤ 1000 ppb
• Trace Impurities - Osmium (Os):
  ≤ 1000 ppb
• Trace Impurities - Rhodium (Rh):
  ≤ 1000 ppb
• Trace Impurities - Ruthenium (Ru):
  ≤ 1000 ppb
• Trace Impurities - Selenium (Se):
  ≤ 8000 ppb
• Trace Impurities - Silver (Ag):
  ≤ 1000 ppb
• Trace Impurities - Platinum (Pt):
  ≤ 1000 ppb
• Trace Impurities - Lithium (Li):
  ≤ 25000 ppb
• Trace Impurities - Antimony (Sb):
  ≤ 9000 ppb
• Trace Impurities - Barium (Ba):
  ≤ 70000 ppb
• Trace Impurities - Molybdenum (Mo):
  ≤ 150000 ppb
• Trace Impurities - Copper (Cu):
  ≤ 30000 ppb
• Trace Impurities - Tin (Sn):
  ≤ 60000 ppb
• Trace Impurities - Chromium (Cr):
  ≤ 110000 ppb
• No Class 1,2,3 or other solvents are used or produced in the:
• J.T.Baker®, Sodium phosphate dibasic, anhydrous USP, Multi-Compendial HP: