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1.00805 SAFC

Titanium(IV) oxide

EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,E 171

Synonym: Titanic anhydride, Titanium dioxide, Titanium(IV) oxide

  • CAS Number 13463-67-7

  • Empirical Formula (Hill Notation) O2Ti

  • Molecular Weight 79.87

  •  MDL number MFCD00011269

  •  E Number E171

  •  EC Index Number 236-675-5

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Coatings & Supporting Materials, Excipients, Solid Dosage Forms More...
Agency/Method   BP
  JP
  Ph Eur
  USP
Quality Level   500
product line   Emprove® Essential
potency   >10000 mg/kg LD50, oral (Rat)
pH   7-8 (20 °C, 100 g/L in H2O, slurry)
bp   2900 °C/1013 hPa
mp   1855 °C
bulk density   850 kg/m3
InChI   1S/2O.Ti
InChI key   GWEVSGVZZGPLCZ-UHFFFAOYSA-N
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

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 %
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
conforms to Ph Eur, BP, USP, JP, E171

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