D(-)-Sorbit 70% 70, Liquid, EMPROVE® ESSENTIAL BP, Ph. Eur., USP, E420 suitable for use as excipient, SAFC®
Lieferant: Merck
Synonyme:
D(-)-Glucit, (2R,3R,4R,5S)-(-)-1,2,3,4,5,6-Hexanhexol, D(-)-Sorbitol, D(-)-Glucitol
1.02994.9050
1.02994.9270
1.02994.9050EA
672
EUR
1.02994.9050
1.02994.9270
D(-)-Sorbit 70% 70, Liquid, EMPROVE® ESSENTIAL BP, Ph. Eur., USP, E420 suitable for use as excipient, SAFC®
D(-)-Sorbit
Sorbitol flüssig (Sorbitsirup, kristallisierend)
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, USP, E 420.
Conforms to the purity criteria on food additives according to the current European Commission Regulation
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Formel:
HOH₂C(CH(OH))₄CH₂OH Molecular Weight: 182.17 g/mol Siedepunkt: 295 Dichte: 1.3 g/cm³ (20 °C) Lagertemperatur: Raumtemperatur |
MDL:
MFCD00004708 CAS-Nummer: 50-70-4 EINECS: 200-061-5 Merck Index: 13,08797 |
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Spezifikation Testergebnisse
| Solid matter | 69.0 - 72.0 % |
| Sorbitol (HPLC, calc.on anhydrous substance) | 92.0 - 101.0 % |
| Sorbitol (HPLC) | ≥ 65.0 % |
| Identity | passes test |
| Appearance of solution (10 %; water) | passes test |
| pH-value (14 %; water) | 5.0 - 7.0 |
| conductivity (25°C) | ≤ 10 |
| As (Arsenic) | ≤ 0.0001 % |
| Ni (Nickel) (#) | ≤ 0.0001 % |
| Pb (Lead) | ≤ 0.00005 % |
| Ethylene glycol (HPLC) | ≤ 0.10 % |
| Diethylene glycol (HPLC) | ≤ 0.10 % |
| Reducing sugars after hydrolysis/total sugar (as glucose) | ≤ 0.5 |
| Reducing sugars (as glucose) | ≤ 0.2 |
| Sulfated ash | ≤ 0.1 |
| Water | 28.5 - 31.0 % |
| Residues of solvents (ICH Q3C) | excluded by manufacturing process |
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