Description
A purified, micronized hydrated magnesium silicate used as a glidant in tablet and capsule manufacturing, as an anti-tack agent in film and sugar coating, and as a dusting powder base. Pharmaceutical Talc is fully purified to meet USP, EP, JP, and BP requirements for asbestos absence, heavy metals, and microbiological control.
White to off-white very fine micronized powder with a characteristic soapy feel. Practically insoluble in water and dilute acids. Lamellar particle morphology delivers low coefficient of friction at boundary surfaces, which is the basis of its glidant and anti-tack roles.
We supply pharmaceutical-grade Talc from manufacturers in China holding ISO, GMP, USP/EP/JP DMF, Halal, Kosher, and other certifications relevant to the product and production. Asbestos-free certification with each batch.
Common market grades include micronized USP/EP/JP pharmaceutical talc (typical D50 of 5 to 15 microns for glidant and coating applications) and ultra-fine micronized grades for ophthalmic and parenteral uses. Source ore selection (Italian, French, Chinese, US) governs trace mineralogy.
Bulk and reduced-MOQ shipments. Batch-level COA covering identification, asbestos absence, loss on ignition, water-soluble substances, acid-soluble substances, iron, calcium, aluminum, heavy metals, particle size, and microbiology against USP, EP, JP, and BP monographs.
Introduction
Talc has been used in pharmaceutical and medicinal applications for centuries and was formalized in the modern pharmacopoeias in the early twentieth century. It is one of the few naturally mined excipients in the modern pharmacopoeial system and remains the standard glidant and anti-tack agent for tablet and capsule manufacturing where pharmaceutical mineral acceptance is required.
Production starts with selective mining and beneficiation of high-purity talc ore, followed by flotation, fine grinding, micronization, and rigorous testing for asbestos and asbestiform minerals. Pharmaceutical grades require asbestos absence by both x-ray diffraction and electron microscopy, in addition to the standard chemical purity and microbiological limits.
Listed in USP-NF, EP, JP, and BP monographs and assigned E553b in food. FDA Inactive Ingredient Database listed for oral solid, topical, and otic routes.
The functional basis of Talc's pharmaceutical use is its lamellar mineral structure: parallel sheets of magnesium silicate held together by weak van der Waals interactions slide past one another under modest shear, delivering the low coefficient of friction that underpins its glidant and anti-tack performance. Inclusion levels are typically 1 to 5 percent in tablet blends and 5 to 20 percent in sugar-coating premixes.
Strategic position: pharmaceutical Talc is the standard mineral glidant where colloidal silicon dioxide is unsuitable (for example, in moist coating premixes where silicon dioxide's high surface area causes processing problems). Source mine selection and asbestos documentation are the principal sourcing criteria above price.
Where it is used
- Glidant in tablet compression and capsule filling
- Anti-tack agent in film and sugar coating premixes
- Polishing agent in sugar-coated tablet manufacturing
- Dusting powder base in topical and dermatological products
- Lubricant in chewable tablet and lozenge manufacturing
- Carrier in topical pharmaceutical powders
- Component of pessary and suppository bases
- Anti-adherent in pan-coating equipment surfaces
Technical data
| Item | Specification |
|---|---|
| Appearance | White to off-white very fine micronized powder |
| Compliance | USP/NF, EP, JP, BP current edition |
| Identification | Conforms to pharmacopoeial tests (XRD) |
| Asbestos and asbestiform minerals | Absent (XRD plus electron microscopy) |
| Loss on ignition | ≤ 7.0% |
| Loss on drying | ≤ 0.5% |
| Acid-soluble substances | ≤ 2.0% |
| Water-soluble substances | ≤ 0.2% |
| Iron-soluble substances | Conforms |
| Aluminum | ≤ 2.0% |
| Calcium | ≤ 0.9% |
| Lead | ≤ 2 mg/kg |
| Heavy metals (as Pb) | ≤ 10 mg/kg |
| Particle size (D50) | 5 to 15 microns (micronized) |
| Bulk density | 0.25 to 0.55 g/mL |
| Total aerobic count | ≤ 100 CFU/g |
| Yeast and mould | ≤ 50 CFU/g |
| E. coli, Salmonella | Absent |
| Source | Mined and beneficiated pharmaceutical talc ore, asbestos-free |
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