Product Overview & China Production Capacity
Microcrystalline Cellulose (MCC, CAS 9004-34-6) is a purified, partially depolymerized cellulose derived from alpha-cellulose through controlled acid hydrolysis. As one of the most versatile pharmaceutical excipients, MCC functions as a binder, filler, disintegrant, and flow aid in tablet and capsule formulations. China’s MCC production capacity surpasses 120,000 metric tons annually, with leading facilities in Anhui, Shandong, and Jiangsu provinces operating continuous hydrolysis and spray-drying lines that produce multiple grades including PH-101, PH-102, PH-112, and PH-200.
Chinese MCC manufacturers utilize refined wood pulp and cotton linter feedstocks, applying mineral acid hydrolysis followed by neutralization, filtration, and spray drying to achieve precisely controlled particle size distributions and moisture content. The resulting product delivers excellent compactibility at low compression forces, making it ideal for direct compression tableting. Each grade is optimized for specific applications: PH-101 for wet granulation, PH-102 for direct compression, and PH-200 for enhanced flowability in high-speed tablet presses.
Manufacturing Standards & Quality Assurance
Production facilities maintain China quality certification, ISO 9001:2015, and FSSC 22000 credentials. Quality control laboratories perform particle size distribution analysis (laser diffraction), bulk and tapped density measurements, moisture content (Karl Fischer), degree of polymerization testing, and heavy metals screening on every batch. Products conform to USP/NF, EP, JP, and ChP monograph requirements. Active DMF registrations with the US FDA and CEP filings with EDQM facilitate global regulatory acceptance.
Environmental controls include HEPA-filtered processing areas, temperature and humidity monitoring, and validated cleaning procedures between grade changeovers. Incoming raw material testing verifies alpha-cellulose content, ash residue, and absence of pesticide residues. Complete batch documentation supports full traceability from wood pulp receipt through finished product release.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 9004-34-6 |
| Chemical Name | Microcrystalline Cellulose |
| Appearance | White or off-white fine powder |
| Particle Size (D50) | 50 µm (PH-101) / 100 µm (PH-102) |
| Moisture Content | 3.0–5.0% |
| Bulk Density | 0.25–0.45 g/cm³ |
| pH (10% suspension) | 5.0–7.5 |
| Heavy Metals | ≤10 ppm |
| Residue on Ignition | ≤0.05% |
| Pharmacopoeial Compliance | USP/NF, EP, JP, ChP |
Packaging & Export Logistics
MCC is supplied in 20 kg or 25 kg multiply paper bags with PE inner liners, loaded onto standard pallets for containerized shipment. Bulk quantities are available in 500 kg FIBCs. All packaging meets food-contact regulatory standards. Typical lead time from order confirmation to port departure is 10–15 business days. Shipments depart from Shanghai, Nantong, and Qingdao ports under FOB, CIF, or DDP terms based on customer requirements.
Each delivery includes CoA, SDS, shipping documentation, and regulatory support files. Dedicated export teams handle customs documentation, phytosanitary certificates, and consolidated freight arrangements for multi-product orders.
China Supply Advantage
China’s dominance in cellulose processing translates to MCC pricing 20–35% below Western-manufactured alternatives with equivalent pharmacopoeial quality. Vertically integrated supply chains from pulp sourcing through finished excipient production ensure consistent quality and reliable delivery schedules. Chinese MCC manufacturers export to pharmaceutical companies in over 70 countries, with proven track records of passing customer audits from major multinational pharma firms. Direct procurement eliminates trading company margins and provides access to technical application support from experienced formulation scientists.