Pharmaceutical-grade ethyl cellulose meeting USP/NF and EP monograph requirements.
Consistent batch-to-batch performance with tight control on ethoxy substitution (48.0–49.5%).
Low residual solvents and heavy metals, compliant with ICH Q3C and Q3D guidelines.
Free-flowing white to off-white granular powder optimized for direct compression and hot-melt extrusion.
Thermoplastic behavior enables robust film formation and sustained-release matrix development.
Sustained-release oral solid dosage forms (e.g., matrix tablets and multiparticulates).
Enteric-coated tablets and pellets requiring pH-independent barrier properties.
Hot-melt extruded (HME) formulations for amorphous solid dispersion stabilization.
Controlled-release coatings in fluid-bed and pan coating processes.
Binders and release modifiers in veterinary pharmaceuticals and nutraceuticals.
| Chemical Type | Ethyl cellulose polymer |
| Product Form | Free-flowing granular powder |
| Appearance | White to off-white, odorless granules |
| Ethoxy Content | 48.0–49.5% (USP/NF compliant) |
| Viscosity (2% in toluene/ethanol 4:1) | 90–110 mPa·s |
| Heavy Metals (as Pb) | ≤ 10 ppm |
| Residual Solvents (Ethanol/Toluene) | ≤ 5000 ppm total (ICH Q3C Class 2/3) |
| Microbial Limits | Compliant with USP <61> (TAMC ≤ 10³ CFU/g; TYMC ≤ 10² CFU/g) |
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E-mail: wangxingqiang@ericwchem.com
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