Product Overview & China Production Capacity
Croscarmellose Sodium (CAS 74811-65-7) is a cross-linked sodium carboxymethylcellulose polymer and one of the three most widely used superdisintegrants in the global pharmaceutical industry. At concentrations of 1–5%, it dramatically accelerates tablet disintegration through rapid water uptake and swelling, enabling fast drug release from both direct compression and wet granulation tablets. Its fibrous particle morphology provides excellent wicking action, making it the preferred superdisintegrant for many formulation scientists.
China has emerged as a significant producer of croscarmellose sodium with combined annual capacity exceeding 15,000 MT. Our manufacturing facility in Henan Province produces 3,000 MT/year using refined cotton linter cellulose, with proprietary cross-linking and drying technology that delivers controlled swelling volume and consistent disintegration performance across batches.
Manufacturing Standards & Quality Assurance
Our facility holds cquality certification with ISO 9001:2015 quality systems. The product meets all requirements of USP/NF, EP, BP, and ChP monographs for Croscarmellose Sodium. We hold Drug Master Files (DMFs) with the US FDA and have completed EU ASMF submissions for key European markets.
Quality control includes degree of substitution, sodium chloride and sodium glycolate content (ion chromatography), settling volume (swelling test), pH, loss on drying, water-soluble substances, heavy metals, and full microbiological testing. Particle size distribution is tightly controlled via laser diffraction to ensure consistent disintegration performance. Batch-to-batch consistency is validated through disintegration time testing in reference tablet formulations.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to slightly grayish free-flowing powder |
| Degree of Substitution | 0.60–0.85 |
| pH (1% suspension) | 5.0–7.0 |
| Loss on Drying | ≤10.0% |
| Sodium Chloride | ≤0.5% |
| Sodium Glycolate | ≤0.5% |
| Water-Soluble Substances | ≤10.0% |
| Settling Volume | 10.0–30.0 mL |
| Heavy Metals (as Pb) | ≤10 ppm |
| Particle Size (D50) | 25–60 µm |
Packaging & Export Logistics
Supplied in 25 kg fiber drums with PE inner bag or 25 kg PE-lined paper bags. Bulk packaging in 500 kg FIBCs available for large orders. Store in a dry environment at 15–25°C in tightly sealed containers. Shelf life is 36 months. Non-hazardous for all transport modes. Container loading approximately 10–12 MT per 20′ FCL.
We export from Qingdao and Shanghai ports with door-to-door logistics services available. Complete documentation provided: COA, MSDS, DMF authorization letters, and stability data. We support regulatory submissions for NDA and ANDA filings.
China Supply Advantage
Sourcing croscarmellose sodium directly from our China facility delivers 40–55% savings compared to established Western superdisintegrant brands, while meeting identical pharmacopeial specifications and performance standards. Our competitive pricing has enabled generic pharmaceutical manufacturers across Asia, Africa, and Latin America to reduce formulation costs without compromising drug product quality.
MOQ is 500 kg with 10–14 business day lead times. We offer both standard and fine-particle grades for different tablet formulation approaches. Sample quantities (5–10 kg) are available for formulation development and qualification studies. Our technical team provides disintegration testing support and formulation troubleshooting. Contact us for pricing and qualification samples.