Microcrystalline Cellulose is purified, partially depolymerized cellulose prepared by treating alpha cellulose obtained as a pulp from fibrous plant material with mineral acids. Several grades of Avicel® PH MCC are available varying in particle size distribution, density and moisture content. Avicel® PH microcrystalline cellulose (MCC) is most often used as a filler, disintegrant, flow aid, and dry binder for tablets and capsules. Avicel® PH-112 has a typical average particle size of 100 µm and lower moisture content of not more than 1.2%. Avicel® PH-112 is primarily used for direct compression, and dry granulation/roller compaction for moisture sensitive Active Ingredients (APIs). The particle size of Avicel® PH-112 provides good flow characteristics. When compressed, Avicel® PH MCC undergoes plastic deformation. The strength of MCC tablets results from hydrogen bonding between the plastically deformed, large surface area cellulose particles. MCC is recognized as the most compactable of any direct compression excipient.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

Dosage Form: Capsules, Effervescent Tablets, Granules, Orally Disintegrating Tablets (ODTs), Pellets, Tablets

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)

Manufacturing Technology: Direct Compression, Dry Granulation, Extrusion, Spheronization, Wet Granulation

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    IFF Pharma Solutions Portfolio Brochure

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Enhanced TDS

Identification & Functionality

Applications & Uses

Properties

Physical Form
Soluble in
Copper Tetrammine Hydroxide
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Dryingmax. 1.5%-
Bulk Density0.28 - 0.34g/cc-
Identification (A,B)Passes--
Degree of Polymerization (Identification C)max. 350units-
pH5.5 - 7.0--
Conductivitymax. 75μS/cm-
Residue on Ignitionmax. 0.05%-
Water Soluble Substancesmax. 12.5mg/5g-
Water Soluble Substancesmax. 0.25%-
Ether Soluble Substancesmax. 5.0mg/10g-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 100cfu/g-
Total Yeast and Mold Countmax. 20cfu/g-
Pseudomonas aeruginosaAbsent10g-
E. coliAbsent10g-
Staphylococcus aureusAbsent10g-
SalmonellaAbsent/10g-
ColiformAbsent10g-
Specifications
ValueUnitsTest Method / Conditions
Particle Size Distribution (D10)14 - 50--
Particle Size Distribution (D50)70 - 150--
Particle Size Distribution (D90)160 - 295--
Particle Size (Air Jet, + 60 mesh (250 microns))max. 8wt.%-
Particle Size (Air Jet, + 200 mesh (75 microns))min. 45wt.%-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metalsmax. 0.001%-
Note

*More restrictive than compendium

Regulatory & Compliance

Storage & Handling

Shelf Life
4 years
Storage Conditions

Store at ambient conditions. Keep containers sealed; material is very hygroscopic.IFF recommends that after the above re- evaluation date, the customer perform the loss on drying test.