Product Overview & China Production Capacity
Crospovidone (Cross-linked Polyvinylpyrrolidone / PVPP, CAS 25249-54-1) is a water-insoluble, cross-linked homopolymer of N-vinyl-2-pyrrolidone that functions as a superdisintegrant in pharmaceutical tablet and capsule formulations. At 2–5% concentration, it enables rapid disintegration through capillary wicking and elastic recovery mechanisms without forming a viscous gel layer. Crospovidone is also used as a stabilizer for suspensions and as an adsorbent for polyphenols in beverage clarification.
China has developed significant crospovidone manufacturing capacity, with total production exceeding 8,000 MT annually. Our facility in Anhui Province produces 2,500 MT/year of pharmaceutical-grade crospovidone through controlled popcorn polymerization of NVP monomer, achieving the characteristic porous particle morphology essential for high wicking performance.
Manufacturing Standards & Quality Assurance
Production is quality-certified with ISO 9001:2015 quality management. The product meets USP/NF, EP, BP, and ChP monograph specifications for Crospovidone. We hold US FDA DMF and support EU ASMF registrations. Our polymerization process uses pharmaceutical-grade NVP monomer with stringent residual monomer control (<10 ppm vinyl pyrrolidone in finished product).
Quality testing includes nitrogen content assay, residual vinyl pyrrolidone (GC-MS), peroxide value, pH, loss on drying, sulfated ash, water-soluble substances, heavy metals, and microbial limits. Particle size and bulk density are controlled to produce both Type A (fine particle, 10–30 µm) and Type B (coarse particle, 100–130 µm) grades per pharmacopeial classifications.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to cream-white powder |
| Nitrogen Content | 11.0–12.8% |
| Vinyl Pyrrolidone (residual) | ≤10 ppm |
| Peroxide Value | ≤400 ppm |
| pH (2% slurry) | 5.0–8.0 |
| Loss on Drying | ≤5.0% |
| Sulfated Ash | ≤0.4% |
| Water-Soluble Substances | ≤1.5% |
| Heavy Metals (as Pb) | ≤10 ppm |
| Particle Size (D50) | Type A: 10–30 µm / Type B: 100–130 µm |
Packaging & Export Logistics
Supplied in 25 kg fiber drums with PE inner bag or 20 kg PE-lined paper bags. Due to low bulk density, bulk packaging in 200 kg FIBCs is available for Type B. Store at 15–25°C in tightly sealed containers, protected from moisture and oxidizers. Shelf life is 36 months. Non-hazardous for transport. Container loading: 6–8 MT per 20′ FCL for Type A; 10–12 MT for Type B.
Exports ship from Shanghai and Ningbo ports with established logistics to global pharmaceutical markets. Complete documentation package includes COA, MSDS, DMF authorization letter, TSE/BSE declaration, and stability data.
China Supply Advantage
Direct direct sourcing of pharmaceutical-grade crospovidone from China offers 45–60% cost savings versus leading European and American brands. Our vertically integrated NVP monomer-to-polymer production chain eliminates external supply dependencies and ensures both cost competitiveness and quality control throughout the manufacturing process.
MOQ is 200 kg with 10–14 business day production lead times. Both Type A (for wet granulation) and Type B (for direct compression) grades are stocked for rapid dispatch. We provide application-specific technical support including disintegration studies, stability compatibility data, and formulation optimization guidance. Request your qualification samples today.