Specification Test Results

• Meets J.P. Chemical Specifications:
• Meets N.F. Requirements:
• GMP Manufactured Product:
• Meets E.P. Chemical Specifications:
• Store in airtight container.:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• NF - Clarity and Color of Solution:
  Passes Test
• NF - Identification A:
  Passes Test
• NF - Identification B:
  Passes Test
• NF - Specific Rotation [Å]²º^D (+):
  54.4 - 55.9 Degree
• NF - Microbial Limits - Total Aerobic Microbial Counts, cfu/g:
  ≤100
• NF - Microbial Limits - Total Combined Molds and Yeasts Count (per g):
  ≤50
• NF - Microbial Limits - Escherichia Coli and Salmonella:
  Passes Test
• NF - Acidity or Alkalinity:
  Passes Test
• NF - Loss on Drying at 80°C:
  ≤0.5 %
• NF - Water (H₂O):
  4.5 - 5.5 %
• NF - Residue on Ignition:
  ≤0.1 %
• NF - Protein and Light-Absorbing Impurities:
  Passes Test
• EP - Identification A:
  Passes Test
• EP - Identification B:
  Passes Test
• EP - Identification C:
  Passes Test
• EP - Identification D:
  Passes Test
• EP - Specific Rotation [Å]²º^D (+):
  54.4 - 55.9 Degree
• EP - Sulfated Ash:
  ≤0.1 %
• EP - Microbial Limits - Total Aerobic Microbial Count, cfu/g:
  ≤100
• EP- Microbial Limits - Total Combined Molds and Yeasts Count (per g):
  ≤50
• EP - Microbial Limits - Escherichia coli (absent):
  Passes Test
• EP - Acidity or Alkalinity:
  Passes Test
• EP - Water (H₂O):
  4.5 - 5.5 %
• EP - Protein and Light-Absorbing Impurities:
  Passes Test
• EP - Appearance of Solution:
  Passes Test
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Identification A:
  Passes Test
• JP - Specific Rotation [Å]²º^D (+):
  54.4 - 55.9 Degree
• JP - Microbial Limits - Total Aerobic Microbial Count, cfu/g:
  ≤100
• JP - Microbial Limits - Total Combined Molds and Yeasts Count (per g):
  ≤50
• JP - Microbial Limits - Escherichia Coli and Salmonella:
  Passes Test
• JP - Acidity or Alkalinity:
  Passes Test
• JP - Water (H₂O):
  4.5 - 5.5 %
• JP - Loss on Drying at 80°C:
  ≤0.5 %
• JP - Residue on Ignition:
  ≤0.10 %
• JP - Heavy Metals (as Pb):
  ≤5 ppm
• JP - Protein and Light-Absorbing Impurities:
  Passes Test
• Endotoxin Concentration (EU/g), For Information Only:
• No Class 1,2,3 or other solvents are used or produced in the:
• manufacturing or purification of the product.:
• 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.:
• Internationally Harmonized: