Microcrystalline Cellulose (MCC 101)

Premium pharmaceutical excipient for direct compression with excellent binding and disintegration properties

Binder Grade USP/EP Direct Compression
Microcrystalline Cellulose MCC 101

Product Overview

Direct Compression

Ideal for direct compression processes with excellent compactibility and flow properties.

Excellent Binding

Superior binding properties ensuring strong tablet integrity and mechanical strength.

Disintegration Aid

Provides controlled disintegration properties for optimal drug release profiles.

Chemical Inertness

Chemically inert with excellent compatibility with various active pharmaceutical ingredients.

Quick Info

  • Chemical Name: Microcrystalline Cellulose
  • Grade: MCC 101
  • Function: Binder, Disintegrant, Filler
  • Appearance: White, odorless powder
  • Particle Size: ~50 μm (average)
  • Moisture Content: ≤ 5.0%
  • pH: 5.0 - 7.5
Compliance
USP EP JP IP
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Technical Specifications

Parameter Specification Test Method
Appearance White, odorless, crystalline powder Visual
Identification Complies with USP/EP standards IR Spectroscopy
pH (1% slurry) 5.0 - 7.5 USP <791>
Loss on Drying ≤ 5.0% USP <731>
Residue on Ignition ≤ 0.1% USP <281>
Heavy Metals ≤ 10 ppm USP <231>
Particle Size Distribution D50: 45-65 μm Laser Diffraction
Bulk Density 0.26 - 0.31 g/mL USP <616>
Tapped Density 0.35 - 0.46 g/mL USP <616>
Compressibility Index ≤ 20% USP <616>
Degree of Polymerization ≥ 350 USP Method
Microbial Limits Total Aerobic Count: ≤ 1000 CFU/g
Yeast & Mold: ≤ 100 CFU/g
USP <61>

Applications

Direct Compression

Primary application as binder and filler in direct compression tablet formulations.

Immediate Release Tablets

Excellent for immediate release formulations with controlled disintegration properties.

Wet Granulation

Compatible with wet granulation processes as a binder and disintegrant.

Chewable Tablets

Provides pleasant mouthfeel and texture in chewable tablet formulations.

Capsule Filling

Used as diluent and flow aid in capsule formulations for improved processing.

Low Dose Formulations

Ideal diluent for low dose active ingredients requiring precise content uniformity.

Regulatory Compliance

Our Microcrystalline Cellulose (MCC 101) meets the highest international pharmaceutical standards and regulatory requirements.

USP

United States Pharmacopeia

EP

European Pharmacopoeia

JP

Japanese Pharmacopoeia

IP

Indian Pharmacopoeia

BP

British Pharmacopoeia

Certifications

ISO 9001:2015
Quality Management
ISO 14001:2015
Environmental Management
ISO 45001:2018
Occupational Health & Safety
ISO 22000:2018
Food Safety Management
FSSAI
Food Safety Standards
WHO-GMP
Good Manufacturing Practice
HALAL
Halal Certified
KOSHER
Kosher Certified

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