Hypromellose (HPMC) 9004-65-3 — China Manufacturer | Pharma-Grade Excipient R&D to Production

Product Overview & China Production Capacity

Hypromellose (HPMC) (Hydroxypropyl Methylcellulose / HPMC, CAS 9004-65-3) is one of the most widely used cellulose ether excipients in the global pharmaceutical industry. It serves multiple critical functions: film-coating polymer for tablet coating, sustained-release matrix former for controlled-release tablets, binder in wet granulation, viscosity modifier in ophthalmic solutions, and capsule shell material for vegetarian capsules. Different substitution types (E, F, K grades) and viscosity grades enable precise formulation control across all dosage forms.

China is the world’s largest HPMC producer with annual capacity exceeding 600,000 MT. Our cellulose ether facility in Shandong Province produces 50,000 MT/year with dedicated pharmaceutical-grade lines operating at 8,000 MT/year capacity. We manufacture from refined cotton linter and wood pulp cellulose using a proprietary heterogeneous etherification process that delivers exceptional substitution uniformity.

Manufacturing Standards & Quality Assurance

Our pharmaceutical HPMC production holds ISO 9001:2015, and ISO 14001 certifications. The product meets USP/NF (Hypromellose), EP (Hypromellose), JP, and ChP monograph specifications across all substitution types. We maintain US FDA DMF registrations and support EU ASMF submissions. Multiple substitution types are produced: 2910 (E grade), 2906 (F grade), and 2208 (K grade).

Quality testing includes methoxyl and hydroxypropoxyl content (substitution type verification), viscosity determination (Ubbelohde capillary and Brookfield), pH, loss on drying, residue on ignition, heavy metals, chloride, and microbial limits. Gel temperature, thermal gelation behavior, and film-coating performance data are available for each grade. We provide application-specific technical data packages for coating, matrix, and capsule applications.

Technical Specifications

ParameterSpecification
AppearanceWhite to slightly off-white fibrous powder
Methoxyl Content28.0–30.0%
Hydroxypropoxyl Content7.0–12.0%
Viscosity (2% solution, 20°C)3–200,000 mPa·s (grade dependent)
pH (1% solution)5.0–8.0
Loss on Drying≤5.0%
Residue on Ignition≤1.5%
Heavy Metals (as Pb)≤10 ppm
Chloride≤0.5%
Gel Temperature58–64°C (Type 2910)

Packaging & Export Logistics

Supplied in 25 kg multiply paper bags with PE liner or 25 kg fiber drums. Bulk packaging in 500 kg FIBCs with PE inner bag. Store at 15–25°C in tightly sealed containers in a dry environment. Shelf life is 48 months from manufacture. Non-hazardous for transport. Container loading: approximately 10–14 MT per 20′ FCL depending on viscosity grade and bulk density.

We export from Qingdao and Shanghai ports to over 90 countries with established pharmaceutical distribution networks. Complete documentation includes COA, MSDS, DMF authorization letters, and substitution type certificates.

China Supply Advantage

As the world’s dominant HPMC production base, China offers pharmaceutical-grade hypromellose at 40–60% below equivalent Western cellulose ether producers. Our scale of production and efficient cotton linter sourcing within China’s integrated textile-chemical supply chain provide unmatched cost competitiveness without quality compromise.

MOQ is 500 kg per grade with 7–14 business day lead times. We stock the most popular pharmaceutical grades (E3, E5, E6, E15, E50, K4M, K15M, K100M) for immediate dispatch. Custom viscosity specifications and blended grades are available. Our pharmaceutical applications team provides coating trial support, dissolution profile optimization, and capsule filling guidance. Contact us for grade recommendations and competitive pricing.

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