Specification Test Results

• tested and the concentration reported for each batch.:
• 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.:
• Suitable for use in the manufacture of parenteral dosage forms.:
• Meets N.F. Requirements:
• GMP Manufactured Product:
• Meets E.P. Chemical Specifications:
• Meets B.P. Chemical Specifications:
• Meets J.P. Chemical Specifications:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• NF - Identification:
  Passes Test
• NF - Appearance of Solution:
  Passes Test
• NF - Color Value:
  ≤45
• NF - Conductivity:
  ≤35 µS/cm
• NF - Optical Rotation (+):
  66.3 - 67.0 Degree
• NF - Reducing Sugars:
  Passes Test
• NF - Sulfite (SO2):
  ≤10 ppm
• NF - Loss on Drying at 105 ºC:
  ≤0.1 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Conductivity, uS cm-1:
  ≤35
• EP/BP - Optical Rotation (+):
  66.3 - 67.0 Degree
• EP/BP - Colour Value:
  ≤45
• EP/BP - Reducing Sugars:
  Passes Test
• EP/BP - Sulfite (SO₂):
  ≤10 ppm
• EP/BP - Loss on Drying at 105°C:
  ≤0.1 %
• JP - Identification:
  Passes Test
• JP - Optical Rotation (+):
  66.3 - 67.0 Degree
• JP - Color Value:
  ≤45
• JP - Clarity of Solution:
  Passes Test
• JP - Dextrins:
  Passes Test
• JP - Sulfite (SO₂):
  ≤10 ppm
• JP - Conductivity, uS cm-1:
  ≤35
• JP - Loss on Drying at 105°C:
  ≤0.1 %
• JP - Reducing Sugars:
  Passes Test
• Assay (HPLC):
  ≥99 %
• Endotoxin Concentration (EU/g):
  ≤0.6
• Microbial Testing - Salmonella (USP):
  None Detected
• Microbial Testing - E. coli (USP):
  None Detected
• Microbial Testing - Staphylococcus aureus (USP):
  None Detected
• Microbial Testing - Pseudomonas aeruginosa (USP):
  None Detected
• Microbial Testing - Total Yeast and Molds (USP):
  ≤100 cfu/g
• Microbial Testing - Total Aerobic Microbial Count (USP):
  ≤100 cfu/g
• Microbial Testing -Bile tolerant gram-negative bacteria:
  None Detected
• Microbial Testing - Clostridia:
  None Detected
• Microbial Testing - Candida albicans:
  None Detected
• Trace Impurities - Aluminum (Al), For Information Only:
• Trace Impurities - Arsenic (As), For Information Only:
• Trace Impurities - Cadmium (Cd), For Information Only:
• Trace Impurities - Chromium (Cr), For Information Only:
• Trace Impurities - Copper (Cu), For Information Only:
• Trace Impurities - Iridium (Ir), For Information Only:
• Trace Impurities - Iron (Fe), For Information Only:
• Trace Impurities - Lead (Pb), For Information Only:
• Trace Impurities - Manganese (Mn), For Information Only:
• Trace Impurities - Mercury (Hg), For Information Only:
• Trace Impurities - Molybdenum (Mo), For Information Only:
• Trace Impurities - Nickel (Ni), For Information Only:
• Trace Impurities - Osmium (Os), For Information Only:
• Trace Impurities - Palladium (Pd), For Information Only:
• Trace Impurities - Platinum (Pt), For Information Only:
• Trace Impurities - Rhodium (Rh), For Information Only:
• Trace Impurities - Ruthenium (Ru), For Information Only:
• Trace Impurities - Vanadium (V), For Information Only:
• Trace Impurities - Zinc (Zn), For Information Only:
• Residual Methanol:
  ≤3000 ppm
• Residual Ethanol:
  ≤5000 ppm
• Residual Isopropanol:
  ≤5000 ppm
• Residual Solvents: Only the Class 2 solvent Methanol and the Class 3:
• solvents Ethanol and Isopropanol are likely to be present. Each is:
• J.T.Baker®, D-(+)-Sucrose (beet-derived) NF, HPLE, multi-compendial parenteral grade low in endotoxins: