Specification Test Results

• Endotoxin Concentration, EU/g:
  ≤0.6
• Trace Impurities - Aluminum (Al), For Information Only:
• Trace Impurities - Arsenic (As), For Information Only:
• Trace Impurities - Cadmium (Cd), For Information Only:
• Trace Impurities - Copper (Cu), For Information Only:
• Trace Impurities - Chromium (Cr), 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
• Cyanide (CN):
  ≤100 ppb
• Residual Solvents: Only the Class 2 solvent Methanol and the Class 3:
• Solvents Ethanol and Isopropanol are likely to be present. Each is:
• 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.:
• Plant Derived.:
• Suitable for use in the manufacture of parenteral dosage forms.:
• Meets N.F. Requirements:
• GMP Manufactured Product:
• Meets B.P. Chemical Specifications:
• Meets J.P. Chemical Specifications:
• Meets E.P. Chemical Specifications:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• NF - Assay (HPLC):
  97.0 - 102.0 %
• NF - Chloride (Cl):
  ≤0.0125 %
• NF - Color and Clarity of Solution: Absorbance @ 720 nm:
  ≤0.050
• NF - Color 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 [Å]²º^D (+):
  197 - 201 Degree
• NF - Sulfate (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 [Å]²º^D (+):
  197 - 201 Degree
• EP/BP - Sulfate (SO₄):
  ≤200 ppm
• EP/BP - Sulfated ash:
  ≤0.1 %
• EP/BP - Water (by Karl Fischer:
  9.0 - 11.0 %
• JP - Assay (LC):
  98.0 - 101.0 %
• JP - Chloride (Cl):
  ≤0.018 %
• JP - Dextrin, soluble starch and sulfite:
  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 [Å]²º^D (+):
  197 - 201 Degree
• JP - Sulfate (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 [Å]²º^D (+):
  177.5 - 180.5 Degree