Specification Test Results

• Meets B.P. Chemical Specifications:
  —
• Meets E.P. Chemical Specifications:
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• Meets J.P. Chemical Specifications:
  —
• GMP Manufactured Product:
  —
• Meets U.S.P Requirements:
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• CAUTION: For Manufacturing, processing or repackaging:
  —
• Bulk Pharmaceutical Chemical:
  Passes Test
• USP - Identification A:
  Passes Test
• USP - Identification B:
  Passes Test
• USP - Identification C: Water (H₂O):
  ≤1.0 %
• USP - Assay (Anhydrous basis):
  97.5 - 102.0 %
• USP - Related substances: Maltose and isomaltose:
  ≤0.4 %
• USP - Dextrin:
  Passes Test
• USP - Related substances: Maltotriose:
  ≤0.2 %
• USP - Related substances: Fructose:
  ≤0.15 %
• USP - Related substances: Unspecified impurities, each:
  ≤0.10 %
• USP - Related substances: Total Impurities:
  ≤0.5 %
• USP - Color and Clarity of Solution:
  Passes Test
• USP - Soluble Starch, Sulfites:
  ≤15 ppm
• USP - Conductivity (uS cm-1):
  ≤20 µS/cm
• EP/BP - Identification A (Specific Rotation (+)):
  52.5 - 53.3 Degree
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification E:
  Passes Test
• EP/BP - Assay (C₆H₁₂O₆) (anhydrous substance):
  97.5 - 102.0 %
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Conductivity, uS cm-1:
  ≤20
• EP/BP - Related Substances: sum of impurities A and B:
  ≤0.4 %
• EP/BP - Related Substances: impurity C:
  ≤0.2 %
• EP/BP - Related Substances: impurity D:
  ≤0.15 %
• EP/BP - Related Substances: unspecified impurities, each:
  ≤0.10 %
• EP/BP - Related Substances: total impurities:
  ≤0.5 %
• EP/BP - Dextrins:
  Passes Test
• EP/BP - Soluble starch, sulfite:
  ≤15 ppm
• EP/BP - Water (H₂O):
  ≤1.0 %
• Endotoxin Concentration (EU/g):
  ≤5.0
• JP - Identification 1:
  Passes Test
• JP - Identification 2:
  Passes Test
• JP - Water (H₂O):
  ≤1.0 %
• JP - Assay (Anhydrous basis):
  97.5 - 102.0 %
• JP - Maltose and isomaltose:
  ≤0.4 %
• JP - Maltotriose:
  ≤0.2 %
• JP - Fructose:
  ≤0.15 %
• JP - Unspecified Impurities, each:
  ≤0.10 %
• JP - Total Impurities:
  ≤0.5 %
• JP - Color and Clarity of Solution:
  Passes Test
• JP - Soluble Starch, Sulfites:
  ≤15 ppm
• JP - Conductivity (uS cm-1):
  ≤20 µS/cm
• JP - Dextrin:
  Passes Test
• JP - Heavy Metals (as Pb):
  ≤4 ppm