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-301 has a typical average particle size of 50 µm with a high bulk density of approximately 0.4 g/cc, compared to 0.3 g/cc for most other Avicel® grades. Avicel® PH-301 is primarily used for high shear wet granulation and direct compression. The high bulk density provides increased flowability resulting in improved blending characteristics and tablet uniformity. The high density also helps improve consistency and throughput of the capsule filling process.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

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

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

Manufacturing Technology: Direct Compression, Dry Granulation, 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
Typical Properties
ValueUnitsTest Method / Conditions
Degree Polymerization100 - 300--
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Drying3.0 - 5.0%-
Bulk Density0.34 - 0.45g/cc-
Identification (A,B)Passes--
Degree of Polymerizationmax. 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-
Specifications
ValueUnitsTest Method / Conditions
Particle Size Distribution (D10)10 - 30--
Particle Size Distribution (D50)35 - 80--
Particle Size Distribution (D90)80 - 170--
Particle Size (Air Jet, + 60 mesh (250 microns))max. 1.0wt.%-
Particle Size (Air Jet, + 200 mesh (75 microns))max. 30wt.%-
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.