Spezifikation Testergebnisse

• GMP Manufactured Product:
  Passes Test
• Store and ship product between 2 and 8 °C:
  5.00 - 7.00
• CAUTION: For Manufacturing, processing or repackaging:
  ≤1%
• Appearance (white to off-white solid):
  Passes Test
• Identification (IR):
  Passes Test
• pH of 5% Solution:
  5.00 - 7.00
• Specific Rotation @ 25 °C:
  -34.5 - -28.5 Degree
• Melting Point:
  110 - 122 °C
• Water (H₂O), For Information Only:
  ≤5000 ppm
• Purity (by HPLC) (anhydrous basis):
  ≥98 %
• Assay (by HPLC) (anhydrous basis):
  98 - 102
• Endotoxin Concentration, EU/g:
  –34.5 - –28.5°
• Residual Methanol:
  ≤3000 ppm
• Residual Ethanol:
  ≤5000 ppm
• Residual Isopropanol:
  ≤5000 ppm
• Residual Ethyl Acetate:
  ≤5000 ppm
• Total Aerobic Microbial Count:
  ≤100 cfu/g
• Total Yeast and Mold Count:
  ≤100 cfu/g