D(-)-Sorbitol 70% ≥70%, liquide, EMPROVE® ESSENTIAL E420, BP, Ph. Eur., USP suitable for use as excipient, SAFC®
Fournisseur: MERCK PRODUCTION CHEMICALS
Synonyms:
(2R,3R,4R,5S)-Hexane-1,2,3,4,5,6-hexaol, (Sorbitol), D(-)-Glucitol, D-Sorbitol, Sorbitol
Sorbitol liquide (Sorbitol sirop, cristallisable)
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
Formule:
HOH₂C(CH(OH))₄CH₂OH MW: 182.17 g/mol Point d'ébullition: 295 Densité: 1.3 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00004708 Numéro CAS: 50-70-4 EINECS: 200-061-5 Merck Index: 13,08797 |
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Résultats des tests de spécification
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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