Product Overview & China Production Capacity
Low-Substituted HPC (L-HPC, CAS 9004-64-2) is a water-insoluble cellulose ether derivative with a low degree of hydroxypropyl substitution (5.0–16.0%). Unlike regular HPC which is fully water-soluble, L-HPC is insoluble in water but swells significantly upon hydration, making it an effective disintegrant and binder in pharmaceutical tablet formulations. It combines the dual functionality of promoting disintegration while providing useful binding properties during compression, making it a unique excipient for direct compression and wet granulation processes.
China has developed substantial L-HPC manufacturing capacity, with combined annual output exceeding 5,000 MT. Our cellulose ether facility in Shandong Province produces 2,000 MT/year of pharmaceutical-grade L-HPC through controlled heterogeneous etherification of purified cellulose, achieving precise hydroxypropyl substitution levels across multiple grades (LH-11, LH-21, LH-31 types).
Manufacturing Standards & Quality Assurance
Production is quality-certified with ISO 9001:2015 quality management. The product meets USP/NF, EP, JP, and ChP monograph specifications for Low-Substituted Hydroxypropyl Cellulose. We hold US FDA DMF and support regulatory submissions in all major pharmaceutical markets. Our production process uses pharmaceutical-grade cellulose and propylene oxide with stringent residual reagent control.
Quality control includes hydroxypropoxyl content determination, pH, loss on drying, residue on ignition, heavy metals, chloride, settling volume (swelling capacity), particle size distribution, and microbial limits. Each L-HPC grade is characterized by its disintegration efficiency and binding capacity in reference tablet formulations to ensure batch-to-batch functional consistency.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to yellowish-white fibrous powder |
| Hydroxypropoxyl Content | 5.0–16.0% (grade dependent) |
| pH (1% suspension) | 5.0–7.5 |
| Loss on Drying | ≤5.0% |
| Residue on Ignition | ≤0.5% |
| Heavy Metals (as Pb) | ≤10 ppm |
| Chloride | ≤0.36% |
| Settling Volume | Grade-specific (6.0–30.0 mL) |
| Particle Size | Grade-specific (D50: 20–50 µm typical) |
| Arsenic | ≤2 ppm |
Packaging & Export Logistics
Supplied in 20 kg fiber drums with PE inner bag or 25 kg PE-lined paper bags. Store in a dry environment at 15–25°C in tightly sealed containers. Shelf life is 36 months. Non-hazardous for transport. Container loading: approximately 8–10 MT per 20′ FCL due to low bulk density.
We export from Qingdao and Shanghai ports with door-to-door logistics service. Complete documentation package includes COA, MSDS, DMF authorization letter, and application technical data sheets.
China Supply Advantage
Sourcing pharmaceutical-grade L-HPC from our China facility provides 45–60% cost savings compared to established Japanese producers who historically dominated this excipient market. Chinese L-HPC manufacturers have achieved full quality equivalence with imported products, enabling significant cost reduction for generic pharmaceutical companies worldwide.
MOQ is 200 kg per grade with 10–14 business day lead times. We stock LH-11 (low substitution, high disintegration), LH-21 (medium), and LH-31 (high substitution, stronger binding) grades. Sample kits for formulation development are available. Our technical team provides disintegration and binding performance comparison data. Contact us for grade selection and competitive competitive pricing.