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| Feature | Good stability |
| Classification | Paint Additives |
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Ethyl cellulose, as an important pharmaceutical excipient widely used in the preparation of pharmaceutical preparations, has excellent thickening, adhesion, film-forming, thermoplasticity, compatibility, physical stability, chemical stability, non-toxicity and harmlessness. It is widely used in oral and topical preparations, and can be used as skeleton materials for slow-release preparations, coating materials, microencapsulation materials, adhesives, drug carriers and backing materials.
Pharmaceutical grade ethyl cellulose (EC) is a non-toxic, inert, and water-insoluble polymer derived from cellulose. It is widely used in drug formulations as a binder, coating agent, and controlled-release matrix due to its excellent film-forming properties, chemical stability, and compatibility with active pharmaceutical ingredients (APIs).
| Property | Specification | Test Method |
|---|---|---|
| Appearance | White to off-white powder | Visual inspection |
| Ethoxyl Content | 44.0–51.0% | USP/Ph. Eur. |
| Viscosity (5% in toluene:ethanol) | 4–100 mPa·s | Ubbelohde viscometer |
| Moisture Content | ≤3.0% | Karl Fischer titration |
| Solubility | Soluble in organic solvents (ethanol, acetone) | USP <911> |
| Application | Function | Typical Use Level |
|---|---|---|
| Tablet Coating | Moisture barrier, taste masking | 2–10% w/w |
| Matrix Tablets | Controlled-release agent | 10–30% w/w |
| Granulation Binder | Improves tablet hardness | 2–5% w/w |
| Microencapsulation | Protects APIs from degradation | 5–20% w/w |
| Topical Gels/Ointments | Thickening & stabilization | 1–5% w/w |
| Standard | Requirement | Compliance Status |
|---|---|---|
| USP-NF | Meets ethyl cellulose monograph | Compliant |
| Ph. Eur. | Complies with EP 9.0 standards | Compliant |
| JP (Japanese Pharmacopoeia) | Conforms to JP 18 specifications | Compliant |
| ICH Q3D | Heavy metals <10 ppm | Compliant |
| Residual Solvents | Meets ICH Q3C Class 2/3 limits | Compliant |
| Feature | Benefit in Pharmaceutical Use |
|---|---|
| pH-independent release | Stable in GI tract conditions |
| High chemical stability | Resists hydrolysis & oxidation |
| Excellent film-forming | Uniform, flexible coatings |
| Non-ionic nature | Minimal drug interactions |
| Low hygroscopicity | Reduces moisture sensitivity |
| Parameter | Recommendation |
|---|---|
| Storage conditions | 15–30°C, ≤65% RH |
| Shelf life | 36 months in sealed containers |
| Handling precautions | Use dust mask & gloves |
| Packaging | 5/25 kg HDPE-lined kraft bags |
| Regulatory status | GRAS, FDA 21 CFR 172.868 |
Pharmaceutical grade ethyl cellulose is a versatile excipient for controlled-release formulations, tablet coatings, and drug encapsulation. Its regulatory compliance, stability, and functional versatility make it indispensable in modern pharmaceutical manufacturing.
Declaration: The products displayed on this website are intended exclusively for industrial applications or scientific research. They are not intended for medical, pharmaceutical, or food use. In accordance with applicable laws and regulations, purchasing organizations must hold valid qualifications and approvals.
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