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Parteck® M 200 (Mannitol) 98.0-101.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421, SAFC®
 :  MilliporeSigma
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Parteck® M 200 (Mannitol) 98.0-101.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421, SAFC®
 :  MilliporeSigma
 
Restricted Products: To process your orders without delay, please provide the required business documentation to purchase this product.

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  • • State Department of Health Services License
  • • Any other ID issued by the State that includes the business name & address

* ATTN: California Customers may require additional documentation as part of the CA Health & Safety Code. Products that fall under this regulation will be placed on a mandatory 21-day hold after documentation is received. Avantor will not lift restrictions for residential shipping addresses.

 

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  • Assay (HPLC, calc. on dried substance):
    98.0 - 101.0 %
  • Identity (NIR):
    passes test
  • Identity (IR-spectrum):
    passes test
  • Identity (wet chemistry):
    passes test
  • Appearance of solution (13 %; water):
    passes test
  • Free acid:
    passes test
  • pH-value (10 %; water):
    4.5 - 7.5
  • Melting point:
    166 - 169
  • Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance):
    137 - 145 °
  • Conductivity (25°C) (20 %; water):
    ≤ 20
  • Arsenic (As):
    ≤ 2
  • Ni (Nickel) (#):
    ≤ 1
  • Pb (Lead):
    ≤ 0.5
  • Chloride (Cl):
    ≤ 0.003 %
  • Sulfate (SO₄):
    ≤ 0.01 %
  • Heavy metals (as Pb):
    ≤ 5 ppm
  • Oxalate (C₂O₄):
    ≤ 0.02 %
  • 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 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Related substances (HPLC) (Sum of all impurities):
    ≤ 2.0 %
  • Reducing sugars after hydrolysis/total sugar (as glucose):
    ≤ 1
  • Reducing sugars (as glucose):
    ≤ 0.05
  • Sulfated ash:
    ≤ 0.1
  • Loss on Drying (105 °C):
    ≤ 0.30 %
  • Water:
    ≤ 0.5 %
  • Particle size (< 53 µm):
    ≤ 15 %
  • Particle size (> 500 µm):
    ≤ 15 %
  • Microbiological test:
    passes test
  • Colony count (aerobic bacteria (TAMC)):
    ≤ 10³
  • Colony count (Yeasts and moulds (TYMC)):
    ≤ 10²
  • Salmonella spp.:
    in 10 g Substance not detectable
  • E.coli:
    in 1 g Substance not detectable
  • Staphylococcus aureus:
    in 1g Substance not detectable
  • Pseudomonas aeruginosa:
    in 1g Substance not detectable
  • Candida albicans:
    In 1g Substance not detectable