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

Supplier: MilliporeSigma

Synonyms: SorbitolD(-)-Glucitol(Sorbitol)

1.11597.1003 1.11597.9023 1.11597.9024 1.11597.1003 1.11597.9024 1.11597.9027
EM1.11597.9023EA 1083.26 USD
CA1.11597.1003 EM1.11597.9023 CA1.11597.9024 EM1.11597.1003 EM1.11597.9024 CA1.11597.9027
Parteck® SI 400 LEX (Sorbitol), EMPROVE® exp Ph. Eur., BP, NF, JP suitable for use as excipient
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
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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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