Pharmaceutical Excipient

Microcrystalline Cellulose

Name: Microcrystalline Cellulose (MCC)
Brand: Chelora Pharmachem
SKU: CAS-9004-34-6
Availability: InStock

CAS 9004-34-6 · (C₆H₁₀O₅)ₙ · E460(i)

The gold-standard excipient for direct-compression tableting, capsule filling and wet granulation. Chelora supplies IP/BP/USP-NF compliant MCC in three particle-size grades — PH-101, PH-102 and PH-200 — with full batch documentation.

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IP / BP / USP-NF grades
Non-hazardous (Non-DG)
PH-101 / PH-102 / PH-200

Microcrystalline cellulose pharmaceutical excipient

MCC quality checking and sample analysis

grades available

CAS number

9004-34-6

Particle sizes

50 – 180 µm

Pharmacopoeia

IP · BP · USP-NF

Transport

Non-DG

Product overview

The backbone of modern tablet formulation

Microcrystalline cellulose (MCC) is a purified, partially depolymerised cellulose obtained by controlled acid hydrolysis of alpha-cellulose from wood pulp. The process removes the amorphous regions, leaving behind tightly packed crystalline microfibrils that give MCC its exceptional compressibility, plastic deformation behaviour and self-disintegrating properties.

Since its introduction in the 1960s, MCC has become the single most important excipient in solid-dosage pharmaceutical manufacturing. It allows direct compression — the simplest and most cost-effective tableting method — by providing both binding and filling functions in a single material. Tablets compressed from MCC blends exhibit excellent hardness, low friability and rapid disintegration.

Chelora supplies three standard particle-size grades that cover the full range of formulation needs. PH-101 (≈ 50 μm) is a fine powder grade used in wet granulation and small-tablet direct compression. PH-102 (≈ 100 μm) is the most widely used granular grade for standard direct-compression tableting and capsule filling. PH-200 (≈ 180 μm) is a coarse, free-flowing grade designed for high-speed rotary presses where excellent flow through the hopper and into the die cavity is critical.

All grades meet the monograph requirements of the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia — National Formulary (USP-NF) and European Pharmacopoeia (Ph. Eur.). Beyond pharma, MCC is a permitted food additive (E460i) and is used as a cosmetic bulking agent, making it one of the most versatile cellulose derivatives in commercial use.

Technical specifications

IUPAC nameCellulose, microcrystalline

SynonymsMCC, Avicel, Cellulose gel, E460(i)

CAS number9004-34-6

EINECS number232-674-9

Molecular formula(C₆H₁₀O₅)ₙ

Molecular weightVariable (polymeric; monomer unit 162.14)

AppearanceWhite, odourless, free-flowing powder

Particle size (PH-101)≈ 50 µm (powder grade)

Particle size (PH-102)≈ 100 µm (granular grade)

Particle size (PH-200)≈ 180 µm (coarse grade)

Bulk density (PH-102)0.28 – 0.36 g/mL

pH (10 % aqueous slurry)5.0 – 7.5

Moisture content≤ 5.0 %

Residue on ignition≤ 0.05 %

Heavy metals (as Pb)≤ 10 ppm

Degree of polymerisation< 350 (USP/NF requirement)

Solubility in waterPractically insoluble; swells

Pharmacopoeia complianceIP / BP / USP‑NF / Ph. Eur.

Food additive codeE460(i)

StorageCool, dry place; protect from moisture

TransportNot classified as dangerous goods (Non-DG)

Applications & end uses

Where Microcrystalline Cellulose is used

Tablet binder & filler (direct compression)

MCC is the excipient of choice for direct-compression tableting. Its excellent compressibility, plastic deformation and self-disintegrating properties allow formulators to produce robust tablets without wet granulation, reducing process steps and cost.

Capsule diluent

In hard-gelatin and HPMC capsule formulations, MCC serves as a diluent and bulking agent that improves powder flow, fill-weight uniformity and content uniformity — especially important when API doses are small relative to capsule volume.

Wet granulation aid

During wet granulation, MCC acts as both a binder and an intragranular disintegrant. It absorbs and distributes the granulating fluid, promotes uniform granule formation and supports rapid disintegration of the finished tablet.

Stabiliser in suspensions

Colloidal grades of MCC are used in pharmaceutical and food suspensions as a thixotropic stabiliser. The cellulose microcrystals form a gel network that prevents sedimentation of active particles and provides a creamy mouthfeel.

Food additive (E460i)

As E460(i), microcrystalline cellulose is a permitted food additive used as an anticaking agent, fat replacer and texture modifier in dairy products, sauces, baked goods and processed meats. It is calorie-free and GRAS-listed.

Cosmetic bulking agent

In personal-care products, MCC provides bulk, improves texture and serves as a mild abrasive in scrubs and exfoliating cleansers. Its inert, non-irritant character makes it compatible with a wide range of cosmetic bases.

Available grades

Three particle-size grades for every formulation need

All grades meet IP, BP, USP-NF and Ph. Eur. monograph requirements. Each batch ships with a COA confirming compliance.

≈ 50 µm

PH-101 (powder)

Wet granulation, small-tablet direct compression

≈ 100 µm

PH-102 (granular)

Standard direct compression, capsule filling

≈ 180 µm

PH-200 (coarse)

High-speed direct compression, improved flowability

Packaging options

Moisture-protected pharmaceutical packaging

25 kg — Double-polyethylene-lined paper bag

Standard pharmaceutical unit

20 kg — Fibre drum with PE liner

Moisture-sensitive storage applications

Sample — Sealed HDPE container

QC evaluation before production commitment

Documentation supplied

Complete paperwork for QC and regulatory

Certificate of Analysis (COA)

Batch-specific results for particle size, bulk density, moisture, pH, residue on ignition, heavy metals and microbial limits.

Safety Data Sheet (SDS)

GHS-format, 16-section SDS covering handling, dust-explosion precautions and disposal.

Pharmacopoeia compliance statement

Confirmation that the grade meets the relevant IP, BP, USP-NF or Ph. Eur. monograph.

Drug Master File (DMF) reference letter

Reference letter for Type IV DMF filed with CDSCO / FDA where applicable.

Frequently asked questions

Common questions about Microcrystalline Cellulose

What is the difference between PH-101, PH-102 and PH-200?+

The three grades differ primarily in average particle size and, consequently, in flowability and compressibility. PH-101 (≈ 50 µm) is a fine powder suited to wet granulation and small-tablet direct compression. PH-102 (≈ 100 µm) is the most widely used granular grade for standard direct-compression tableting. PH-200 (≈ 180 µm) is a coarse, free-flowing grade designed for high-speed tablet presses where excellent flow is critical.

Does Chelora's MCC meet pharmacopoeia standards?+

Yes. All three grades meet the monograph requirements of the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia and National Formulary (USP-NF) and European Pharmacopoeia (Ph. Eur.). Each batch ships with a COA and a pharmacopoeia compliance statement.

Is Microcrystalline Cellulose classified as a dangerous good?+

No. MCC is not classified as dangerous goods for transport. Standard packaging and labelling apply. It is a GRAS-listed substance with a long history of safe use in pharmaceutical and food applications.

Can MCC be used in food products?+

Yes. Microcrystalline cellulose is approved as food additive E460(i) across the EU, US, India and most global markets. It functions as an anticaking agent, fat replacer and texture modifier and is calorie-free.

What is the typical lead time for a bulk order?+

Standard lead time is 5 – 10 working days for domestic orders and 10 – 14 days for export. PH-102 is held in regular stock; PH-101 and PH-200 may require a short lead time depending on volume. We can often expedite for urgent requirements.

Do you offer samples before bulk purchase?+

Yes. Sample quantities of all three grades are available so your formulation and QC teams can evaluate the material against your specification before committing to a production order.

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