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D-(-)-Mannitol 98.0-101.0%, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, USP, E421, SAFC®
Catalog # EM1.00494.9025
Supplier:  MilliporeSigma
CAS Number:  
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D-(-)-Mannitol 98.0-101.0%, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, USP, E421, SAFC®
Catalog # EM1.00494.9025
Supplier:  MilliporeSigma
Supplier Number:  1.00494.9025
CAS Number:  

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Specifications

  • Pack type:
    Fibre carton
  • Size:
    25 kg
  • Cat. No.:
    EM1.00494.9025
  • Supplier no.:
    1.00494.9025

Specifications

Specification Test Results

  • Assay (HPLC, calc. on dried substance):
    98.0 - 101.0 %
  • Identity (NIR):
    passes test
  • Appearance of solution (10 %; water):
    passes test
  • pH-value (10 %; water):
    4.5 - 7.5
  • Melting point:
    165 - 169
  • Conductivity (25°C) (20 %; water):
    ≤ 20
  • Heavy metals (as Pb):
    ≤ 5 ppm
  • Ni (Nickel) (#):
    ≤ 1 ppm
  • Pb (Lead):
    ≤ 0.5 ppm
  • Related substances (HPLC) (Sorbitol (Impurity A)):
    ≤ 2.0 %
  • Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C)):
    ≤ 2.0
  • Related substances (HPLC) (Major unspecified impurity):
    ≤ 0.10 %
  • Related substances (HPLC) (Sum of all impurities):
    ≤ 2.0 %
  • Reducing sugars (as glucose):
    ≤ 0.05
  • Reducing sugars after hydrolysis/total sugar (as glucose):
    ≤ 1
  • Sulfated ash:
    ≤ 0.1
  • Water:
    ≤ 0.5 %
  • Loss on Drying (105 °C):
    ≤ 0.30 %
  • Particle size ( 212 µm):
    ≤ 20 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Microbiological test:
    passes test
  • Colony count (aerobic bacteria (TAMC)):
    ≤ 10³
  • Colony count (Yeasts and moulds (TYMC)):
    ≤ 10²
  • Salmonella spp.:
    in 10g Substance not detectable
  • E.coli:
    in 1g Substance not detectable
  • Staphylococcus aureus:
    in 1g Substance not detectable
  • Pseudomonas aeruginosa:
    in 1g Substance not detectable
  • Candida albicans:
    In 1g Substance not detectable

Specification Test Results

About this item

 :
 :182.17 g/mol
Boiling Pt:290…295 °C
Melting Pt:164…169 °C
CAS Number:69-65-8
Formula:HOH₂C(CH(OH))₄CH₂OH
MDL Number:MFCD00064287