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Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT Ph. Eur., BP, NF, JP suitable for use as excipient, SAFC®
  MERP1.11597.2500
 :  MERCK PRODUCTION CHEMICALS
 :  
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Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT Ph. Eur., BP, NF, JP suitable for use as excipient, SAFC®
  MERP1.11597.2500
 :  MERCK PRODUCTION CHEMICALS
 :  

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  • Pack type:
    Plastic bottle
  • Pk:
    2,5 kg
  • Seq:
    4076

 

 

  • Assay (HPLC, calc.on anhydrous substance):
    97.0 - 100.5 %
  • Identity:
    passes test
  • pH-value (10 %; water):
    3.5 - 7.0
  • Appearance of solution (25 %; water):
    passes test
  • Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance):
    +4.0 - +7.0 °
  • Conductivity (25°C) (20 %; water):
    ≤ 20
  • Chloride (Cl):
    ≤ 0.002 %
  • Sulfate (SO₄):
    ≤ 0.006 %
  • Heavy metals (as Pb):
    ≤ 5 ppm
  • As (Arsenic):
    ≤ 1.3 ppm
  • Ni (Nickel) (#):
    ≤ 1 ppm
  • Pb (Lead):
    ≤ 0.5 ppm
  • Related substances (HPLC, EP) (Major impurity (Mannitol)):
    ≤ 2.0 %
  • Related substances (HPLC, EP) (Sum of all impurities):
    ≤ 3.0 %
  • Reducing sugars after hydrolysis/total sugar (as glucose):
    ≤ 0.8
  • Reducing sugars (as glucose):
    ≤ 0.11 %
  • Sulfated ash:
    ≤ 0.02 %
  • Loss on drying:
    ≤ 2.0 %
  • Water:
    ≤ 1.5 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Microbiological test:
    passes test
  • Colony count (aerobic bacteria (TAMC)):
    ≤ 10²
  • Colony count (Yeasts and moulds (TYMC)):
    ≤ 10²
  • Salmonella spp.:
    in 10g Substance not detectable
  • E.coli:
    in 1g substance not detectable
  • Pseudomonas aeruginosa:
    in 1g substance not detectable
  • Staphylococcus aureus:
    in 1g substance not detectable
  • Candida albicans:
    In 1g substance not detectable
  • Endotoxins:
    ≤ 1

 

 

 :
 :13,08797
 :295 °C (1013 hPa)
 :94…98 °C
 :1.524 g/cm³ (20 °C)
 :>100 °C
 :182.17 g/mol
 :Ambient
 :200-061-5
 :50-70-4
 :98201-93-5
 :HOH₂C(CH(OH))₄CH₂OH
 :MFCD00004708