Specification Test Results

• impurities for this product is available on the associated Product:
• Regulatory Data Sheet and elemental impurity profile report.:
• Meets B.P. Chemical Specifications:
• Meets E.P. Chemical Specifications:
• GMP Manufactured Product:
• Meets JPC (1997) Chemical Specifications:
• Meets U.S.P Requirements:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• USP - Assay (C₄H₁₁NO₃):
  99.0 - 101.0 %
• USP - Identification A:
  Passes Test
• USP - Identification B:
  Passes Test
• USP - Identification C:
  Passes Test
• USP - pH (1 in 20):
  10.0 - 11.5
• USP - Residue on Ignition:
  ≤0.1 %
• USP - Loss on Drying:
  ≤0.5 %
• USP - Melting Range(Lower):
  168 - 172 °C
• USP - Melting Range(Upper):
  168 - 172 °C
• EP/BP - Assay (C₄H₁₁NO₃) (dried basis):
  99.0 - 100.5 %
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - pH:
  10.0 - 11.5
• EP/BP - Related Substances:
  ≤1.0 %
• EP/BP - Chloride (Cl):
  ≤100 ppm
• EP/BP - Iron (Fe):
  ≤10 ppm
• EP/BP - Loss on Drying at 105°C:
  ≤0.5 %
• EP/BP - Ash (sulfated):
  ≤0.1 %
• JPC 1997 - Assay (C₄H₁₁NO₃) (dried basis):
  ≥99.0 %
• JPC 1997 - Identification A:
  Passes Test
• JPC 1997 - Identification B:
  Passes Test
• JPC 1997 - pH:
  10.3 - 10.7
• JPC 1997 - Melting Point:
  168 - 172 °C
• JP - Clarity and Color of Solution:
  Passes Test
• JPC 1997 - Heavy Metals (as Pb):
  ≤8 ppm
• JPC 1997 - Arsenic (As):
  ≤1.6 ppm
• JPC 1997 - Loss on Drying:
  ≤0.5 %
• JPC 1997 - Residue on Ignition:
  ≤0.10 %
• Assay (C₄H₁₁NO₃) (dried basis):
  ≥99.9 %
• Absorbance of a 1M Solution - 260 nm:
  ≤0.06
• Absorbance of a 1M Solution - 280 nm:
  ≤0.06
• Absorbance of a 1M Solution - 400 nm:
  ≤0.01
• Endotoxin Concentration (EU/g):
  ≤2.5
• Iron (Fe):
  ≤1 ppm
• Lead (Pb):
  ≤1 ppm
• Water (H₂O)(by Karl Fischer titrn):
  ≤0.5 %
• Enzyme Activity - DNase Activity:
  Passes Test
• Enzyme Activity - RNase Activity:
  Passes Test
• Enzyme Activity - Protease Activity:
  Passes Test
• Trace Impurities - Arsenic (As):
  ≤1 ppm
• Trace Impurities - Aluminum (Al):
  ≤5.000 ppm
• Trace Impurities - Barium (Ba):
  ≤5 ppm
• Trace Impurities - Bismuth (Bi):
  ≤5 ppm
• Trace Impurities - Calcium (Ca):
  ≤10.0 ppm
• Trace Impurities - Cadmium (Cd):
  ≤5.000 ppm
• Trace Impurities - Chromium (CR):
  ≤5 ppm
• Trace Impurities - Cobalt (Co):
  ≤5.000 ppm
• Trace Impurities - Copper (Cu):
  ≤5 ppm
• Trace Impurities - Lithium (Li):
  ≤5 ppm
• Trace Impurities - Magnesium (Mg):
  ≤5 ppm
• Trace Impurities - Mercury (Hg):
  ≤5 ppm
• Trace Impurities - Molybdenum (Mo):
  ≤5 ppm
• Trace Impurities - Nickel (Ni):
  ≤5.000 ppm
• Trace Impurities - Potassium (K):
  ≤50 ppm
• Trace Impurities - Sodium (Na):
  ≤50.000 ppm
• Trace Impurities - Strontium (Sr):
  ≤5 ppm
• Trace Impurities - Vanadium (V):
  ≤5.000 ppm
• Trace Impurities - Zinc (Zn):
  ≤5.000 ppm
• 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: