Titanium(IV)oxide 99,0-100,5 Dried, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E171, extra_pure suitable for use as excipient, SAFC®
Dostawca: MERCK PRODUCTION CHEMICALS
Synonim:
Titanic anhydride, Pigment White 6, Rutile, Titanium(IV) oxide, rutile, Titanium dioxide
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.
Formuła:
TiO₂ MW: 79.88 g/mol Temp. Wrzenia: 2900 Temp. topnienia: 1855 Gęstość: 4.2 g/cm³ (20 °C) Temperatura przechowywania: Temperatura otoczenia |
Numer MDL:
MFCD00011269 Numer CAS: 13463-67-7 Numer WE (dawny EINECS): 236-675-5 Klasyfikacja Merck : 13,09549 |
Wyniki testów specyfikacyjnych
Assay (cerimetric, calculated on dried substance) | 99.0 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
Substances soluble in water (Hotextract) | ≤ 0.5 % |
Substances soluble in water (Coldextract) | ≤ 0.25 % |
Substances soluble in dilute hydrochloric acid | ≤ 0.5 % |
Acidity or alkalinity | passes test |
Aluminium oxide and/or Silicon dioxide | ≤ 2.0 % |
Heavy metals (as Pb) | ≤ 0.002 % |
Acid soluble barium (Ba) | passes test |
Acid soluble antimony (Sb) | ≤ 0.0002 % |
As (Arsenic) | ≤ 0.0001 % |
Cd (Cadmium) | ≤ 0.00005 % |
Fe (Iron) | ≤ 0.02 % |
Hg (Mercury) | ≤ 0.0001 % |
Pb (Lead) | ≤ 0.0010 % |
Sb (Antimony) | ≤ 0.005 % |
V (Vanadium)* | ≤ 0.0010 % |
Zn (Zinc) | ≤ 0.005 % |
Residual solvents (Ph Eur/USP/ICH) | excluded by the manufacturing process |
Microbiological test (Total yeast and mould count (TYMC)) | ≤ 100 CFU/g |
Microbiological test (Total aerobic microbial count (TAMC)) | ≤ 100 CFU/g |
Particle Size (d10) | ≥ 0.1 µm |
Particle Size (d50) | about 0.8 |
Particle Size (d90) | ≤ 2.5 µm |
Loss on ignition (800 °C) | ≤ 0.5 % |
Loss on drying (105 °C; 3 h) | ≤ 0.5 % |
Conforms to Ph. Eur., BP, USP, JP, E171 |
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