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

Supplier: MERCK PRODUCTION CHEMICALS

Synonyms: SorbitolD(-)-Glucitol(Sorbitol)

1.11597.2500EA 239 EUR
1.11597.2500 1.11597.9028 1.11597.9012
Parteck® SI 400 LEX (Sorbitol), EMPROVE® exp Ph. Eur., BP, NF, JP suitable for use as excipient, SAFC®
D(-)-Sorbitol

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 (#).


Certifications: corresponds to Ph. Eur., BP, NF, JP

Formula: HOH₂C(CH(OH))₄CH₂OH
MW: 182,17 g/mol
Boiling Pt: 295 °C (1013 hPa)
Melting Pt: 94…98 °C
Density: 1,524 g/cm³ (20 °C)
Flash Pt: >100 °C
Storage Temperature: Ambient
MDL Number: MFCD00004708
CAS Number: 50-70-4
EINECS: 200-061-5
Merck Index: 12,08873
https://ie.vwr.com/stibo/web/std.lang.all/97/21/2299721.jpg

Order Now

Specification Test Results

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

Learn more

About VWR

Avantor is a vertically integrated, global supplier of discovery-to-delivery solutions for...

Learn more About VWR