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1.11597 SAFC

Parteck® SI 400 LEX (Sorbitol)

suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP

Synonym: D-Glucitol

  • CAS Number 50-70-4

  • Linear Formula C₆H₁₄O₆

  • Molecular Weight 182.17 g/mol

  •  EC Number 200-061-5

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Properties

Related Categories Biopharmaceutical Manufacturing, Excipients for Liquid Formulation, Excipients for Solid Formulation, Process Development and Manufacturing, Small Molecule Pharmaceutical Manufacturing More...
grade   Ph Eur,BP,NF,JP
packaging   2.5 kg in Plastic bottle (1115972500)
  25 kg in Fibre carton (1115979028)
solubility   2350 g/l
density   1.49 g/cm3 (20 °C)
flash point   >100 °C
autoignition temp.   420 °C
mp   94 - 96 °C
pH   6 - 7 (100 g/l, H₂O, 20 °C)
bulk density   450 kg/m3
LD 50 oral   LD50 Rat 15900 mg/kg
shipped in   ambient
storage temp.   Storage temperature: no restrictions.
specifications   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
  Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (#).
  corresponds to Ph. Eur., BP, NF, JP
Safety & Documentation

Safety Information

HS Code 
2905 44 91
RTECS 
LZ4290000
Storage class 
10 - 13 Other liquids and solids
WGK 
NWG not water endangering
Disposal 
3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Declaration (railroad and road) ADR, RID 
Kein Gefahrgut
Declaration (transport by air) IATA-DGR 
No Dangerous Good
Declaration (transport by sea) IMDG-Code 
No Dangerous Good

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