Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT NF, JP, Ph. Eur., BP suitable for use as excipient, SAFC®

Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT NF, JP, Ph. Eur., BP suitable for use as excipient, SAFC®

: (2R,3R,4R,5S)-Hexane-1,2,3,4,5,6-hexaol, (Sorbitol), D(-)-Glucitol, D-Sorbitol, Sorbitol

:50-70-4

:98201-93-5

:HOH₂C(CH(OH))₄CH₂OH

:MFCD00004708

:295

:94…98 °C

:1.524 g/cm³ (20 °C)

:182.17 g/mol

:>100 °C

:13,08797

:Ambient

:200-061-5

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