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myo-Inositol 97.0-102.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL NF, Ph. Eur., FCC suitable for use as excipient, SAFC®
myo-Inositol 97.0-102.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL NF, Ph. Eur., FCC suitable for use as excipient, SAFC®
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myo-Inositol 97.0-102.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL NF, Ph. Eur., FCC suitable for use as excipient, SAFC®
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Assay (HPLC, calc.on anhydrous substance):
    97.0 - 102.0 %
  • Identity:
    conforms
  • Appearance of solution (10 %; water):
    passes test
  • Electrical conductivity:
    ≤ 20 µS/cm
  • Melting range (lower value):
    ≥ 224 °C
  • Melting range (upper value):
    ≤ 227 °C
  • Chloride (Cl):
    ≤ 0.0050 %
  • Sulfate (SO₄):
    ≤ 0.0050 %
  • Ba (Barium):
    conforms
  • Ca (Calcium):
    conforms
  • Pb (Lead):
    ≤ 0.00005 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Related substances/HPLC (EP) (Impurity A):
    ≤ 0.3 %
  • Related substances/HPLC (EP) (Impurity B):
    ≤ 0.3 %
  • Related substances/HPLC (NF) (Major unspecified impurity):
    ≤ 0.3 %
  • Related substances/HPLC (EP) (Major unspecified impurity):
    ≤ 0.10 %
  • Related substances/HPLC (EP) (Sum of all impurities):
    ≤ 1.0 %
  • Related substances/HPLC (NF) (Sum of all impurities):
    ≤ 1.0 %
  • Sulfated ash:
    ≤ 0.1 %
  • Loss on Drying (105 °C):
    ≤ 0.5 %
  • Water (according to Karl Fischer):
    ≤ 0.5 %

Specification Test Results

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