Product Overview & China Production Capacity
Polyethylene Glycol 4000 (PEG 4000, CAS 25322-68-3, average MW ~4,000) is a free-flowing white powder or flake used extensively as a tablet binder, film-coating plasticizer, suppository base component, and osmotic laxative in pharmaceutical applications. China’s PEG 4000 production capacity ranks among the world’s largest, with high-purity pharma-grade output from multiple production facilities in eastern China. Annual capacity for PEG 4000 alone exceeds 50,000 metric tons across dedicated pharmaceutical-grade production lines.
In tablet manufacturing, PEG 4000 enhances film-coat flexibility and provides moisture protection. It serves as a critical component of suppository bases when blended with lower MW PEGs, and functions as an osmotic laxative (macrogol 4000) in oral solutions. Its complete water solubility, chemical inertness, and well-established safety profile make it one of the most frequently used pharmaceutical excipients globally. Chinese producers achieve tight molecular weight control through advanced polymerization technology and multi-stage purification.
Manufacturing Standards & Quality Assurance
Facilities operate under ISO 9001:2015, and FDA-inspected conditions. QC protocols include hydroxyl value determination, molecular weight distribution analysis (GPC), ethylene glycol and diethylene glycol residues (GC), heavy metals, pH, water content, and microbial limit testing. Products conform to USP/NF Macrogol 4000, EP, and ChP monographs. Active DMFs and CEPs support regulatory submissions globally.
Production monitoring includes automated ethylene oxide dosing, temperature profiling, and in-line viscosity measurement. Post-synthesis processing involves vacuum stripping to remove residual ethylene oxide to below detection limits (<1 ppm). Stability data is generated per ICH guidelines to support shelf-life claims.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 25322-68-3 |
| Average Molecular Weight | 3,500–4,500 |
| Appearance | White powder or flakes |
| Hydroxyl Value | 25–32 mg KOH/g |
| pH (5% aqueous) | 4.5–7.5 |
| Water Content | ≤1.0% |
| Ethylene Glycol + DEG | ≤0.25% |
| Residual Ethylene Oxide | <1 ppm |
| Heavy Metals | ≤10 ppm |
| Pharmacopoeial Compliance | USP/NF, EP, JP, ChP |
Packaging & Export Logistics
PEG 4000 is supplied in 25 kg PE-lined paper bags or 25 kg fiber drums, palletized for efficient container utilization. Bulk packaging in 500 kg or 1,000 kg FIBCs is available. Lead time is 10–15 business days from confirmed order. FOB, CIF, and DDP shipping from Shanghai, Nanjing, and Qingdao ports.
Documentation packages include CoA, SDS, regulatory compliance dossiers, and customs clearance paperwork. Climate-controlled shipping options protect product integrity during transit to warm-climate destinations.
China Supply Advantage
China’s integrated PEG manufacturing ecosystem, from ethylene cracking to finished excipient packaging, delivers pharma-grade PEG 4000 at 25–40% below the cost of comparable Western products. Consistent quality verified by international customer audits and regulatory inspections provides assurance for global pharmaceutical applications. Direct procurement ensures transparent pricing, flexible order quantities from sample sizes to full container loads, and dedicated account management with application engineering support.