Specification Test Results

• GMP Manufactured Product:
• Meets B.P. Chemical Specifications:
• Meets U.S.P Requirements:
• Meets E.P. Chemical Specifications:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• USP - Identification A:
  Passes Test
• USP - Identification B:
  Passes Test
• USP - Specific Gravity at 25°/25°C:
  1.095 - 1.101
• USP - Refractive Index, n²⁵^D:
  1.4755 - 1.4775
• USP - Acidity:
  Passes Test
• USP - Water (H₂O):
  ≤ 0.1 %
• USP - Absorbance - 275 nm:
  ≤ 0.20
• USP - Absorbance - 270-350nm (smooth with no maxima):
  Passes Test
• USP - Absorbance Ratio - 285 nm/275 nm:
  ≤ 0.65
• USP - Absorbance Ratio - 295 nm/275 nm:
  ≤ 0.45
• USP - Nonvolatile Residue:
  ≤ 0.01 %
• USP - Related Compounds:
  ≤ 0.1 %
• USP - Assay ((CH₃)₂SO):
  ≥ 99.9 %
• EP - Identification:
  Passes Test
• EP - Acidity:
  Passes Test
• EP - Relative Density:
  1.100 - 1.104
• EP - Refractive Index:
  1.478 - 1.480
• EP - Freezing Point:
  ≥ 18.3 °C
• EP - Absorbance - 275 nm:
  ≤ 0.30
• EP - Absorbance - 285 nm:
  ≤ 0.20
• EP - Absorbance - 295 nm:
  ≤ 0.20
• EP - Absorbance - 270-350nm (smooth with no maxima):
  Passes Test
• EP - Related Substances: Unspecified impurities, Each:
  ≤ 0.10 %
• EP - Related Substances-Total Impurities:
  ≤ 0.15 %
• EP - Water (H₂O):
  ≤ 0.2 %
• Water (H₂O), For Information Only:
• No Class 1,2,3 or other solvents are used or produced in the:
• manufacturing or purification of the product.:
• Metallic Residues: No metal catalysts or metal reagents, as defined by:
• EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of:
• this material.:
• J.T.Baker®, Dimethyl sulfoxide ≥99.9% USP, Multi-Compendial: