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Methylcellulose (Pharmaceutical Grade)

CAS 9004-67-5 · USP/BP/EP/JP

We source, verify, and export Pharmaceutical Methylcellulose in bulk directly from top Chinese manufacturers to your port.

We provide original COA, MSDS, and other documents directly from the manufacturer with every order.

Mix-container loading, free samples (you may pay the shipment cost), and custom packaging available on request.

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Methylcellulose (Pharmaceutical Grade) — bulk food ingredient sample
FDA GRAS·EU approved·JECFA·Halal · Kosher
01 — Overview

Description

A non-ionic cellulose ether soluble in cold water with the unusual property of thermal gelation on heating. Pharmaceutical Methylcellulose is used as a binder in wet granulation, a viscosity builder in oral liquids, a film former in coating premixes, and a bulk-forming laxative active in over-the-counter products.

White to off-white fibrous or granular powder, soluble in cold water, insoluble in hot water above the gel point of approximately 50 to 60 degrees Celsius. Solutions are clear, pseudoplastic, and resist enzymatic degradation.

We supply pharmaceutical-grade Methylcellulose from manufacturers in China holding ISO, GMP, USP/EP/JP DMF, Halal, Kosher, and other certifications relevant to the product and production.

Common market grades are differentiated by viscosity in 2 percent solution and run from low-viscosity 15 mPa·s for granulation binders through 400, 1,500, and 4,000 mPa·s mid-range grades for oral liquids, up to 15,000 and 100,000 mPa·s high-viscosity grades for sustained-release matrix systems and bulk-laxative tablets.

Bulk and reduced-MOQ shipments. Batch-level COA covering identification, methoxy content, viscosity, loss on drying, residue on ignition, heavy metals, and microbiology against USP, EP, JP, and BP monographs.

02 — Background

Introduction

Methylcellulose was first synthesized in Germany in the early twentieth century and reached pharmaceutical commercial scale in the 1940s. It is the parent of a family of cellulose ethers (Methylcellulose, Hypromellose, Hydroxypropyl Cellulose, Ethylcellulose) that together form the largest single chemistry class in modern excipient practice.

Production proceeds by reaction of purified alkali cellulose with methyl chloride under controlled conditions, introducing methoxy substituents at the cellulose hydroxyls. Degree of substitution (DS) and viscosity are tuned by reaction conditions and by selection of the cellulose feedstock chain length. The crude product is purified, neutralized, dried, and milled to defined particle size.

Listed in USP-NF, EP, JP, and BP monographs and assigned E461 in food. The pharmacopoeial monograph specifies methoxy content of 27.5 to 31.5 percent, defining the substitution range that gives the characteristic cold-water solubility and thermal gelation.

The thermal gelation property is the chemistry's distinguishing feature: cold solutions gel reversibly on heating above 50 to 60 degrees Celsius and return to solution on cooling. This underpins applications in plant-based meat analogues in food, and is exploited in pharmaceutical sustained-release matrices where the gel layer controls drug release.

Strategic position: in regulated pharmaceutical markets, Methylcellulose and the higher-substituted Hypromellose grades together dominate cellulose-ether use, with viscosity-based grade selection driving the choice between binder, suspension, coating, and matrix applications.

03 — Applications

Where it is used

  • Binder in wet-granulation tablet manufacturing
  • Viscosity builder in oral suspensions, syrups, and elixirs
  • Film former in tablet coating premixes
  • Sustained-release matrix former in extended-release tablets
  • Suspending agent in ophthalmic and topical preparations
  • Bulk-forming laxative active in OTC fiber products
  • Mucoadhesive component in buccal and ocular systems
  • Stabilizer in lubricating eye drops and artificial tears
04 — Specifications

Technical data

ItemSpecification
AppearanceWhite to off-white fibrous or granular powder
ComplianceUSP/NF, EP, JP, BP current edition
IdentificationConforms to pharmacopoeial tests
Methoxy content (dried basis)27.5% to 31.5%
Viscosity (2% solution, 20 °C)Grade dependent; 15 to 100,000 mPa·s
Gel temperature50 °C to 60 °C
Loss on drying≤ 5.0%
Residue on ignition≤ 1.5%
pH (1% solution)5.0 to 8.0
Heavy metals (as Pb)≤ 10 mg/kg
Arsenic≤ 2 mg/kg
Particle sizePer grade specification
Total aerobic count≤ 1,000 CFU/g
Yeast and mould≤ 100 CFU/g
E. coli, SalmonellaAbsent
SourcePurified wood pulp or cotton-linter cellulose
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