Product Overview & China Production Capacity
Titanium Dioxide (TiO₂, CAS 13463-67-7, MW 79.87) is a white pigment and opacifier used in pharmaceutical tablet film coatings, capsule shells, topical sunscreen formulations, and food products. China is the world’s largest titanium dioxide producer with annual capacity exceeding 4 million metric tons from both sulfate and chloride process facilities across Sichuan, Shandong, Henan, Guangxi, and Yunnan provinces. Pharma-grade TiO₂ meeting USP/NF and EP specifications is produced at dedicated fine-chemical facilities.
In pharmaceutical coatings, titanium dioxide provides opacity, whiteness, and UV protection to film-coated tablets, improving appearance and protecting light-sensitive APIs. It is a critical component of hard gelatin and HPMC capsule shells, providing the characteristic opaque white appearance. In sunscreen formulations, micronized TiO₂ (anatase or rutile) functions as a physical UV filter. Chinese manufacturers produce both anatase and rutile crystal forms in multiple particle sizes for pharmaceutical, cosmetic, and industrial applications.
Manufacturing Standards & Quality Assurance
Pharma-grade TiO₂ production facilities maintain ISO 9001:2015, and FDA registration. Quality testing includes assay (gravimetric), loss on drying, loss on ignition, water-soluble substances, acid-soluble substances, arsenic, lead, mercury, antimony, and microbial limits. Products comply with USP/NF, EP, FCC, and ChP monograph requirements.
The sulfate process involves dissolving ilmenite in sulfuric acid, followed by hydrolysis, calcination, and surface treatment. The chloride process uses fluidized-bed chlorination of rutile ore followed by vapor-phase oxidation. Pharma-grade material undergoes additional micronization, surface treatment, and classification to achieve target particle size and dispersibility. Heavy metals testing meets stringent pharmaceutical limits.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 13463-67-7 |
| Molecular Formula | TiO₂ |
| Molecular Weight | 79.87 g/mol |
| Appearance | White powder |
| Assay (as TiO₂) | ≥99.0% |
| Crystal Form | Anatase or Rutile |
| Loss on Drying | ≤0.5% |
| Water-Soluble Substances | ≤0.5% |
| Lead | ≤10 ppm |
| Pharmacopoeial Compliance | USP/NF, EP, FCC, ChP |
Packaging & Export Logistics
TiO₂ is supplied in 25 kg PE-lined paper bags or 25 kg valve bags, palletized and stretch-wrapped. Bulk supply in 500 kg or 1,000 kg FIBCs is available. Lead time is 7–12 business days. FOB from Shanghai, Qingdao, or Guangzhou; CIF and DDP terms supported.
Documentation includes CoA, SDS, REACH compliance certificate (for EU market), and commercial shipping paperwork. Non-hazardous classification for pharmaceutical-grade TiO₂ simplifies logistics. Note: EU regulatory status for TiO₂ in food applications (E171) should be verified for specific market requirements.
China Supply Advantage
China’s titanium mineral resources and massive TiO₂ production infrastructure deliver pharma-grade material at 30–50% below Western pricing. Multiple production processes (sulfate and chloride) and abundant raw material sources ensure supply security. Chinese TiO₂ producers export to pharmaceutical, cosmetic, coating, and plastics industries globally with consistent quality validated by international customer audits and regulatory inspections.