Specification Test Results

• Endotoxin Concentration, EU/g:
  ≤0.6
• Arsenic (As):
  ≤0.25 ppm
• Cadmium (Cd):
  ≤0.03 ppm
• Mercury (Hg):
  ≤0.05 ppm
• Lead (Pb):
  ≤0.08 ppm
• Cobalt (Co):
  ≤0.08 ppm
• Nickel (Ni):
  ≤0.33 ppm
• Vanadium (V):
  ≤0.17 ppm
• Silver (Ag):
  ≤0.17 ppm
• Iridium (Ir):
  ≤0.17 ppm
• Gold (Au):
  ≤1.67 ppm
• Osmium (Os):
  ≤0.17 ppm
• Palladium (Pd):
  ≤0.17 ppm
• Platinum (Pt):
  ≤0.17 ppm
• Rhodium (Rh):
  ≤0.17 ppm
• Ruthenium (Ru):
  ≤0.17 ppm
• Selenium (Se):
  ≤1.33 ppm
• Thallium (Tl):
  ≤0.13 ppm
• Barium (Ba):
  ≤11.67 ppm
• Chromium (Cr):
  ≤18.33 ppm
• Copper (Cu):
  ≤5.00 ppm
• Lithium (Li):
  ≤4.17 ppm
• Molybdenum (Mo):
  ≤25.00 ppm
• Antimony (Sb):
  ≤1.50 ppm
• Tin (Sn):
  ≤10.00 ppm
• Aluminum (Al):
  ≤10.00 ppm
• Residual Methanol:
  ≤500 ppm
• Residual Ethanol:
  ≤833 ppm
• Residual Isopropanol:
  ≤833 ppm
• 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:
  ≤0.05 %
• 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