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 compression Aid, filler, flow aid, and dry binder for tablets and capsules. Avicel® PH-101 has a typical average particle size of 50 µm and moisture content between 3 and 5%. Avicel® PH-101 is primarily used for wet granulation, extrusion spherization and tablet compression. Avicel® PH MCC rapidly absorbs aqueous binder solution permitting faster addition of fluid as well as shorter wet massing time. At the same time, the water does not become bound water resulting in faster drying time and uniform granular properties.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

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

Labeling Claims: BSE-free, GMO-free, Generally Recognized As Safe (GRAS), Halal, Kosher, TSE-free, Vegan, Vegetarian

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), FSSC 22000, Generally Recognized As Safe (GRAS), Halal, ISO 9001, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), cGMP

Manufacturing Technology: Direct Compression, Dry Granulation, Wet Granulation

Synonyms: Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
IdentificationPass-A 11-2b
Loss on Dryingmax. 5.0%G 5-6
Water Soluble Substancesmax. 12.0mg/5gA 14-8
Residue on Ignitionmax. 0.05%G 5-11
pH5.5 - 7.0-A 11-5,NF Procedure
Sieve Fraction (Alpine, +60 mesh, 250 microns)max. 1.0% wtG 5-9A
Sieve Fraction (Alpine, +200 mesh, 74 microns)max. 35% wtG 5-9A
Microbiological Values
ValueUnitsTest Method / Conditions
Aerobic Plate Countmax. 1000cfu/gM 20-19
Yeast and Mold Countmax. 100cfu/gM 20-20
SalmonellaAbsent/10gM 20-24
E. coliAbsent/10gM 20-22
Staphylococcus aureusAbsent/10gM 20-23
Pseudomonas aeruginosaAbsent/10gM 20-21
Total Coliformmax. 10cfu/gM 20-25
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metalsmax. 0.001%G 5-7
Note

*More restrictive than compendium

Nutritional Information

Typical Nutrient Information/100g

US EU/Australia/NZ
Estimated Caloric Value 0 Cal

194 Cal/ 811 kJoules

Calories from Fat 0 Cal 0 Cal
Total Fat 0 g 0 g
Saturated Fat 0 g 0 g
Trans-Fat 0 g 0 g
Polyunsaturated Fat 0 g 0 g
Monounsaturated Fat 0 g 0 g
Cholesterol 0 mg 0 mg
Sodium 5 mg 5 mg
Salt 0 g 0.01 g
Potassium 0 mg 0 mg
Total Carbohydrate 0 g 0 g
Sugars (Total) 0 g 0 g
Added Sugars 0 g 0 g
Starch 0 g 0 g
Total Dietary Fiber 97 g 97 g
Dietary Fiber (Soluble) 0 g 0 g
Dietary Fiber (Insoluble) 97 g 97 g
Protein 0 g 0 g
Vitamin A 0 mcg 0 mcg
Vitamin C 0 mg 0 mg
Vitamin D 0 mcg 0 mcg
Calcium 1 mg 1 mg
Iron 0.2 mg 0.2 mg
Magnesium 0 mg 0 mg
Moisture 3 g 3 g
Ash 0 g 0 g
Organic acid 0 g 0 g

Regulatory & Compliance

Storage & Handling

Shelf Life
4 years
Storage Conditions

Store under ambient conditions; unopened packages, under dry (no free moisture) and cool (below 35°C) conditions.