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

Supplier: EMD MILLIPORE – PCS CA EXCEP

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

1.11597.1003 1.11597.9023 1.11597.1003 1.11597.9024 1.11597.9027
CA1.11597.1003EA 539.51 CAD
CA1.11597.1003 EM1.11597.9024 EM1.11597.9023 CA1.11597.9027 EM1.11597.1003
Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT 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
MDL Number: MFCD00004708
CAS Number: 50-70-4
Merck Index: 13,08797
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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

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