Silicium dioxyde 99,0-100,5 calcined_KT, colloidal dispersion, EMPROVE® ESSENTIAL E551, NF, JP, Ph. Eur., extra_pure suitable for use as excipient, SAFC®
Fournisseur: MERCK PRODUCTION CHEMICALS
Synonyms:
Silicon(IV) oxide, Silicium dioxide, Silicium (IV) oxide
- Colloidal
- Highly dispersed
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.
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Certifications: Corresponds to Ph Eur, NF, JP, E551
Formule:
SiO₂ MW: 60.08 g/mol Point d'ébullition: 2230 Point de fusion: 1710 °C Densité: 2.2 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00011232 Numéro CAS: 7631-86-9 EINECS: 231-545-4 Merck Index: 14,08493 |
Résultats des tests de spécification
Identity | Passes Test |
Assay (Calculated on Calcined Substance) | 99.0 - 100.5% |
Substances Soluble in Water | ≤5% |
pH-value (4%, water) | 3.5 - 5.5 |
Chloride (Cl) | ≤0.011% |
Heavy Metals (as Pb) | ≤0.0025% |
Al (Aluminium) | ≤0.0010% |
As (Arsenic) | ≤0.0003% |
Ca (Calcium) | Conforms |
Fe (Iron) | ≤0.0500% |
Hg (Mercury) | ≤0.0001% |
Pb (Lead) | ≤0.0005% |
Pb (Lead) (ICP) | ≤0.0005% |
Residual solvents (ICH Q3C) | Excluded by Production Process |
Loss on Ignition (Dried Substance) | ≤2.0% |
Loss on Drying | ≤2.5% |
Spec. Surface | 200 ± 25 |
Volume Test | Passes Test |
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