Pharmaceutical-Grade Microcrystalline Cellulose

Product Specifications

Technical details and manufacturing context for Pharmaceutical-Grade Microcrystalline Cellulose

Definition

Pharmaceutical-grade microcrystalline cellulose is a purified, partially depolymerized cellulose powder derived from alpha-cellulose through acid hydrolysis. It serves as a multifunctional excipient in solid dosage forms, primarily functioning as a binder, diluent, and disintegrant in tablet manufacturing. This material provides excellent compressibility and flow properties while maintaining chemical inertness and compatibility with active pharmaceutical ingredients. Its consistent particle size distribution and high purity make it essential for achieving uniform tablet hardness and controlled drug release profiles in pharmaceutical production. The material is characterized by a median particle diameter (D50) of 50–100 μm, bulk density of 0.25–0.35 g/cm³, moisture content ≤5.0% w/w, pH (10% suspension) of 5.0–7.5, loss on drying ≤5.0%, heavy metals ≤10 ppm, degree of polymerization 220–240, specific surface area 1.0–2.0 m²/g, ash content ≤0.1%, and organic volatile impurities ≤0.05%. It is insoluble in water. These parameters are specified according to USP and ASTM standards, serving as procurement references. Verification of these values for a specific grade or batch is essential. The material is used in tablet and capsule formulations, where its plastic deformation under compression ensures tablet integrity, and its moisture absorption facilitates disintegration. It is compatible with most active ingredients and other excipients. For any application, confirm the exact specifications with the legal manufacturer or supplier, as actual values may vary by grade.

Working Principle

Microcrystalline cellulose acts as a compressible filler that deforms plastically under pressure to form cohesive tablets. When compressed, the particles flatten and interlock, creating strong bonds without the need for high binder concentrations. Simultaneously, the material absorbs moisture, which promotes tablet disintegration upon ingestion. The balance between plastic deformation and moisture uptake is critical for achieving optimal tablet hardness and drug release. The particle size distribution and bulk density influence flow and compaction behavior, while the degree of polymerization affects binding strength. The specific surface area impacts dissolution and binding efficiency. These physical properties are controlled during manufacturing to ensure consistent performance in pharmaceutical production.

Common Materials

Alpha-cellulose from wood pulp, Hydrochloric acid for hydrolysis

Technical Parameters

Parameter	Typical range	Notes & selection driver
Particle Size D50Required	50–100 μm	Median particle diameter in distributionUSP <786>
Bulk DensityRequired	0.25–0.35 g/cm³	Loose powder density before compressionUSP <616>
Moisture ContentRequired	≤5.0 % w/w	Maximum allowable water contentUSP <921>
pH ValueRequired	5.0–7.5 pH units	Aqueous suspension pH at 10% concentrationUSP <791>
Loss on Drying	≤5.0 %	Weight loss after drying at 105°CUSP <731>
Heavy Metals	≤10 ppm	Maximum lead equivalent concentrationUSP <231>
Degree of Polymerization	220–240	Indicates molecular weightUSP <781>
Specific Surface Area	1.0–2.0 m²/g	Affects dissolution and bindingASTM D3663
Ash Content	≤0.1 %	Purity indicatorUSP <281>
Organic Volatile Impurities	≤0.05 %	Residual solvents limitUSP <467>
Solubility	Insoluble in water	Forms suspension

Ranges are indicative industry figures for RFQ preparation, not a supplier commitment. Confirm every value and standard with the legal manufacturer before ordering.

Components / BOM

Cellulose Polymer Chains Part
Provides structural integrity and binding capacity

Material: Partially depolymerized beta-1,4-glucan chains
Crystalline Domains Part
Enhances compressibility and flow properties

Material: Ordered cellulose regions from acid hydrolysis
Surface Moisture Part
Facilitates plastic deformation during compression

Material: Adsorbed water molecules

Industry Taxonomies & Aliases

Commonly used trade names and technical identifiers for Pharmaceutical-Grade Microcrystalline Cellulose.

Manufacturers of Pharmaceutical-Grade Microcrystalline Cellulose

Manufacturer profiles associated with Pharmaceutical-Grade Microcrystalline Cellulose.

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Procurement Evaluation Criteria

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Frequently Asked Questions

What is the typical particle size of pharmaceutical-grade microcrystalline cellulose?

The median particle diameter (D50) is typically in the range of 50–100 μm, as measured by USP <786>. However, the exact value depends on the specific grade, so always confirm with the supplier.

How does microcrystalline cellulose function as a disintegrant?

It absorbs moisture and swells, which helps break the tablet apart when it comes into contact with gastrointestinal fluids. This property is influenced by its porosity and specific surface area.

What are the key quality parameters to verify for this material?

Key parameters include particle size, bulk density, moisture content, pH, loss on drying, heavy metals, degree of polymerization, specific surface area, ash content, and organic volatile impurities. These are specified in USP and ASTM standards and should be confirmed for each batch.

Is microcrystalline cellulose compatible with most active pharmaceutical ingredients?

Yes, it is chemically inert and generally compatible with a wide range of APIs. However, compatibility studies are recommended for specific formulations, as interactions can occur under certain conditions.

Data Basis

Editorial classification, named public sources where available, and source-reviewed manufacturer records.

Preliminary Technical Classification

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pressure:	Atmospheric to 1 bar gauge (typical mixing/blending), not pressure-rated for containment
flow rate:	Not applicable as solid powder; slurry handling: 0.5-2 m/s in pipelines to prevent settling
temperature:	Ambient to 40°C (storage), processing up to 80°C for short durations
slurry concentration:	5-20% w/v aqueous suspensions for processing, higher concentrations risk viscosity issues