Parteck® SI 150 (Sorbitol) 97.0-100.5%, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, JSFA, E420, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

Synonyms: SorbitolD(-)-Glucitol(Sorbitol)

1.03583.2500EA 0 EUR
1.03583.2500 1.03583.9028
Parteck® SI 150 (Sorbitol) 97.0-100.5%, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, JSFA, E420, SAFC®
D(-)-Sorbitol


Corresponds to Ph. Eur., BP, JP, NF, JSFA, E 420
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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
Free acid passes test
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
Ru (Ruthenium) (#) ≤ 1 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) ≤ 0.5
Reducing sugars (as glucose) ≤ 0.11 %
Sulfated ash ≤ 0.02 %
Loss on drying ≤ 2.0
Water ≤ 1.5 %
Particle size ( 53 µm (270 mesh)) ≤ 5 %
Particle size ( 500 µm (35 mesh)) ≤ 5 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Microbiological test passes test
Colony count (aerobic bacteria (TAMC)) ≤ 5*10²
Colony count (Yeasts and moulds (TYMC)) ≤ 10²
Salmonella spp. in 10g Substance not detectable
E.coli in 1g substance not detectable
Staphylococcus aureus in 1g substance not detectable
Pseudomonas aeruginosa in 1g substance not detectable
Candida albicans In 1g substance not detectable
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, JP, NF, JSFA, E 420
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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