Ethyl Cellulose 9004-57-3 — China GMP Manufacturer | EP USP NF Direct Factory Supply

China Manufacturing Landscape for Ethyl Cellulose

Ethyl Cellulose (CAS 9004-57-3) is an essential pharmaceutical excipient widely used as a coating agent, binder, film-former, and controlled-release matrix material in solid dosage form development. Its insolubility in water combined with excellent film-forming properties makes it indispensable in extended-release formulations, taste-masking coatings, and microencapsulation applications. China has emerged as a leading global production base for pharmaceutical-grade Ethyl Cellulose, with our GMP-certified facility supplying tonnage quantities to pharmaceutical companies, excipient distributors, and formulation development houses worldwide.

With decades of cellulose ether manufacturing expertise and access to abundant cellulose raw materials, Chinese producers have developed sophisticated production capabilities that combine cost efficiency with pharmacopeial-grade quality. Our factory operates dedicated production lines for pharmaceutical-grade Ethyl Cellulose, offering a comprehensive range of viscosity grades and ethoxyl content specifications to meet diverse formulation requirements.

Manufacturing Process & Facility Overview

Our Ethyl Cellulose manufacturing process begins with purified wood pulp cellulose that undergoes alkali treatment to form alkali cellulose, followed by etherification with ethyl chloride under elevated temperature and pressure in autoclave reactors. The resulting crude Ethyl Cellulose is then subjected to washing, neutralization, and multi-stage purification to remove residual reagents and by-products. Final processing includes controlled drying and milling to achieve target particle size distributions.

The production facility features large-capacity pressure reactors (10,000L to 30,000L), automated reagent dosing systems, closed-loop solvent recovery with greater than 98% efficiency, and state-of-the-art fluid bed drying systems. The pharmaceutical-grade finishing area operates under ISO Class 8 cleanroom conditions with controlled temperature and humidity. Total annual production capacity exceeds 3,000 metric tons across all grades.

Quality Standards & Multi-Pharmacopeial Compliance

Our Ethyl Cellulose is manufactured and tested in full compliance with European Pharmacopoeia (EP), United States Pharmacopeia (USP), and National Formulary (NF) monograph specifications. Quality control testing encompasses ethoxyl content determination (meeting specified grade ranges from 44.0% to 51.0%), viscosity measurement at defined concentrations using calibrated Ubbelohde viscometers, loss on drying, residue on ignition, heavy metals by ICP-OES, chloride content, and microbiological quality per pharmacopeial requirements.

We offer multiple standard viscosity grades (7 cP, 10 cP, 20 cP, 45 cP, 100 cP, and 200 cP as measured in 5% w/w solutions) with tight viscosity range control. Our QC laboratory maintains validated test methods and participates in inter-laboratory proficiency testing programs. The quality management system is certified to ISO 9001:2015, and the facility holds valid Chinese GMP and FDA registration.

Regulatory Documentation & Export Support

We provide comprehensive regulatory documentation to support customer qualification and regulatory filing activities. Standard documentation includes batch-specific Certificates of Analysis, MSDS/SDS in GHS format, US FDA Drug Master File (DMF) reference for excipient use, TSE/BSE free certification, allergen-free declarations, and halal/kosher certifications upon request. For EU market access, we supply documentation aligned with EDQM requirements and can support CEP applications.

Additional technical documentation available includes complete physicochemical characterization data, functionality-related characteristics testing per USP guidance, and detailed process description documents. Our regulatory team actively monitors changes to pharmacopeial monographs and proactively updates specifications to maintain continuous compliance.

Packaging & Global Logistics

Ethyl Cellulose is packaged in multi-layer paper bags with polyethylene inner liners, packed in fiber drums with net weights of 20 kg or 25 kg as standard configurations. Bulk packaging in 200 kg or 500 kg flexible intermediate bulk containers (FIBCs) is available for large-volume customers. All packaging materials comply with food-contact and pharmaceutical-grade requirements, and each unit is labeled with complete lot traceability and GHS-compliant information.

We ship globally through established logistics partnerships, offering FOB, CIF, and DDP Incoterms. Given the non-hazardous classification of Ethyl Cellulose, standard freight options provide cost-effective shipping with typical transit times of 20-30 days by sea to major global destinations. Full container load (FCL) and less-than-container load (LCL) options are available, with consolidation services for smaller orders.

Competitive Pricing & Supply Reliability

As a large-scale manufacturer with integrated raw material processing, we offer highly competitive factory-direct pricing for pharmaceutical-grade Ethyl Cellulose. Our pricing structure includes volume-based tiered discounts, annual contract pricing with guaranteed price stability, and preferential terms for long-term supply partnerships. The cost advantages of Chinese manufacturing, combined with our operational efficiency, deliver significant savings compared to Western-origin alternatives without compromising on quality or regulatory compliance.

With large production capacity and efficient inventory management, we maintain consistent stock availability across all standard grades. Our supply chain resilience is demonstrated by uninterrupted production throughout global supply disruptions, and our on-time delivery rate consistently exceeds 98% across all international accounts.

Ethyl Cellulose Technical Specifications