Specification Test Results

• Endotoxin Concentration, EU/g:
  ≤0.6
• Trace Impurities - Aluminum (Al), For Information Only:
  = 0.6
• Trace Impurities - Arsenic (As), For Information Only:
  For Information Only
• Trace Impurities - Cadmium (Cd), For Information Only:
  For Information Only
• Trace Impurities - Chromium (Cr), For Information Only:
  For Information Only
• Trace Impurities - Copper (Cu), For Information Only:
  For Information Only
• Trace Impurities - Iridium (Ir), For Information Only:
  For Information Only
• Trace Impurities - Iron (Fe), For Information Only:
  For Information Only
• Trace Impurities - Lead (Pb), For Information Only:
  For Information Only
• Trace Impurities - Mercury (Hg), For Information Only:
  For Information Only
• Trace Impurities - Manganese (Mn), For Information Only:
  For Information Only
• Residual Methanol:
  ≤3000 ppm
• Residual Ethanol:
  ≤5000 ppm
• Residual Isopropanol:
  ≤5000 ppm
• Cyanide (CN):
  ≤100 ppb
• GMP Manufactured Product:
  —
• Meets BP. Chemical Specifications:
  —
• Meets EP Chemical Specifications:
  —
• Meets JP Chemical Specifications:
  —
• Meets NF Requirements:
  —
• CAUTION: For Manufacturing, Processing or Repackaging:
  —
• Bulk Pharmaceutical Chemical:
  97.0 - 102.0 %
• NF - Assay (HPLC):
  97.0 - 102.0%
• NF - Chloride (Cl):
  ≤0.0125%
• NF - Colour and Clarity of Solution: Absorbance at 720 nm:
  ≤0.050
• NF - Colour and Clarity of Solution, Absorption difference:
  ≤ 0.100
• NF - Identification A:
  Passes Test
• NF - Identification B:
  Passes Test
• NF - Identification C:
  Passes Test
• NF - Microbial Limits: TAMC (cfu/g):
  ≤100 cfu/g
• NF - Microbial Limits: TYMC (cfu/g):
  ≤100 cfu/g
• NF - Microbial Limits: E. coli:
  None Detected
• NF - Microbial Limits: Salmonella:
  None Detected
• NF - Nitrogen Content:
  ≤0.005%
• NF - pH of 10% solution:
  4.5 - 6.5
• NF - Related Substances - Total Peaks Eluting before Trehalose:
  ≤0.5%
• NF - Related Substances - Total Peaks Eluting after Trehalose:
  ≤0.5%
• NF - Residue on Ignition:
  ≤0.10%
• NF - Soluble starch:
  Passes Test
• NF - Specific Optical Rotation, Anhydrous α²ºD (+):
  197 - 201°
• NF - Sulphate (SO₄):
  ≤0.0200%
• NF - Water (by Karl Fischer Titration):
  9.0 - 11.0%
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Assay (LC):
  97.0 - 102.0%
• EP/BP - Chloride (Cl):
  ≤125 ppm
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Microbial Limits: TAMC (cfu/g):
  ≤100 cfu/g
• EP/BP - Microbial Limits: TYMC (cfu/g):
  ≤100 cfu/g
• EP/BP - Microbial Limits: E. coli:
  None Detected
• EP/BP - Microbial Limits: Salmonella:
  None Detected
• EP/BP - pH of 10% Solution:
  4.5 - 6.5
• EP/BP - Related Substances - Impurity A:
  ≤0.5%
• EP/BP - Related Substances - Impurity B:
  ≤ 0.5 %
• EP/BP - Related Substances - Unspecified Impurities, each:
  ≤0.2%
• EP/BP - Related Substances - Total Impurities:
  ≤1.0%
• EP/BP - Soluble starch:
  Passes Test
• EP/BP - Specific Optical Rotation, Anhydrous α²ºD (+):
  197 - 201°
• EP/BP - Sulphate (SO₄):
  ≤200 ppm
• EP/BP - Sulphated Ash:
  ≤0.1%
• EP/BP - Water (by Karl Fischer Titration):
  9.0 - 11.0 %
• JP - Assay (LC):
  98.0 - 101.0%
• JP - Chloride (Cl):
  ≤0.018%
• JP - Dextrin, Soluble Starch and Sulphite:
  Passes Test
• JP - Heavy Metals (as Pb):
  ≤ 5 ppm
• JP - Identification 1:
  Passes Test
• JP - Identification 2:
  Passes Test
• JP - Identification 3:
  Passes Test
• JP - Nitrogen:
  ≤0.005%
• JP - pH of 10% Solution:
  4.5 - 6.5
• JP - Related Substances -Total Peaks Eluting before Trehalose:
  ≤0.5%
• JP - Related Substances -Total Peaks Eluting after Trehalose:
  ≤0.5%
• JP - Residue on Ignition:
  ≤0.1%
• JP - Specific Optical Rotation, Anhydrous α²ºD (+):
  197 - 201°
• JP - Sulphate (SO₄):
  ≤0.024%
• JP - Water (by Karl Fischer Titration):
  9.0 - 11.0%
• Appearance (White to Off White Powder):
  Passes Test
• Conductivity, uS cm-¹:
  ≤15
• Reducing Sugars:
  Passes Test
• Glucose Area%:
  ≤0.5%
• Microbial Testing - Staphylococcus aureus (USP):
  None Detected
• Microbial Testing - Pseudomonas aeruginosa (USP):
  None Detected
• Specific Optical Rotation, Dihydrate α²ºD (+):
  177.5 - 180.5°