Avicel® PH - 113

1 of 16 products in this brand
Avicel® PH - 113 composed of microcrystalline cellulose, finds application in tablet formulations. Manufactured using direct compression, dry granulation, and wet granulation techniques, it serves as a binder and compression aid. Derived from non-animal sources, it meets pharmaceutical and nutraceutical standards.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

Dosage Form: Tablets

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Antibiotics-free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Ethylene Oxide-free, GMO-free, Generally Recognized As Safe (GRAS), Glycerin-free, Halal, Heavy Metal-free, Hormones-free, Kosher, Latex-free, Monosodium Glutamate (MSG)-free, Natural Latex Rubber-Free, Nitrosamines-free, Non-GMO, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plasticizer-free, Preservative-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, Vegetarian

Certifications & Compliance: British Pharmacopeia (BP), Doping-Free, EU Cosmetic Regulation 1223/2009 Compliant, EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FDA Compliant, FDA Food Safety Modernization Act (FSMA), Generally Recognized As Safe (GRAS), Halal, ICH Q3C, IFRA Compliant, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), Regulation (EU) No. 1272/2008, Regulation (EU) No. 231/2012, United States Pharmacopeia (USP), cGMP

Manufacturing Technology: Direct Compression, Dry Granulation, Wet Granulation

Synonyms: Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose

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Enhanced TDS

Identification & Functionality

Chemical Family
Cellulose & Cellulosics
Chemical Name
Cellulose, Microcrystalline
Ingredient Origin
Non-Animal Origin
Pharma & Nutraceuticals Functions
Binder,
Compression Aid,
Filler,
Immediate Release Agent
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Fillers & Diluents,
Formulation & Processing Aids,
Modified & Controlled Release,
Other Excipients

Features & Benefits

Labeling Claims
APE-free,
Allergen-free,
Aluminum-free,
Antibiotics-free,
BSE-free,
Bisphenol A-free,
Caffeine Free,
Colorants-free,
Dioxin-free,
Dye Free,
Endocrine Disruptor-free,
Ethylene Oxide-free,
GMO-free,
Generally Recognized As Safe (GRAS),
Glycerin-free,
Halal,
Heavy Metal-free,
Hormones-free,
Kosher,
Latex-free,
Monosodium Glutamate (MSG)-free,
Natural Latex Rubber-Free,
Nitrosamines-free,
Non-GMO,
PAH-free,
PFAS-Free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-free,
Palm Oil-free,
Paraben-free,
Perfluorooctanoic Acid-free,
Pesticide-free,
Phthalates-free,
Plasticizer-free,
Preservative-free,
Sugar-free,
TSE-free,
Tributyl Tin Compounds-Free,
Triphenyl Tin Compounds-Free,
Vegetarian

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Segments
Pharmaceutical
Applications
Pharmaceutical — Controlled release
Pharmaceutical — Immediate release
Dosage Form
Tablets
Manufacturing Technology
Direct Compression,
Dry Granulation,
Wet Granulation
Product Applications

Tablet Binding

Properties

Physical Form
Powder
Soluble in
Copper Tetrammine Hydroxide
Typical Properties
ValueUnitsTest Method / Conditions
Typical Degree Polymerization Range100 - 300--
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Drying*max. 2%-
Bulk Density0.27 - 0.34g/cc-
Identification (A,B)*Pass--
Degree of Polymerizationmax. 350units-
pH*5.5 - 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. 100*cfu/g-
Yeast and Mold Count (Total)*max. 20cfu/g-
Pseudomonas aeruginosaAbsent/10g-
E. coliAbsent/10g-
Staphylococcus aureusAbsent/10g-
Salmonella SpeciesAbsent/10g-
ColiformAbsent/10g-
Specifications
ValueUnitsTest Method / Conditions
Particle Size Distribution (D50)32-78--
Particle Size (Air Jet, + 60 mesh, 250 microns)max. 1wt%-
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

Certifications & Compliance
British Pharmacopeia (BP),
Doping-Free,
EU Cosmetic Regulation 1223/2009 Compliant,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
European Regulation 396/2005/EC,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
Generally Recognized As Safe (GRAS),
Halal,
ICH Q3C,
IFRA Compliant,
Japan Pharmacopeia (JP),
Kosher,
National Formulary (NF),
Regulation (EU) No. 1272/2008,
Regulation (EU) No. 231/2012,
United States Pharmacopeia (USP),
cGMP
Chemical Inventories
IECSC (China)

Technical Details & Test Data

Nutritional Information

Typical Nutrient Information/100g
US EU/Australia/NZ
Total calories 0 cal 194 cal
Calories from fat 0 cal 0 cal
Total fat 0 g 0 g
Saturated fat 0 g 0 g
Cholesterol 0 mg 0 mg
Sodium 5 mg 5 mg
Salt NA 0.01 g
Total carbohydrate 97 g 0 g
Total dietary fiber 97 g 97 g
Insoluble fiber 97 g 97 g
Soluble fiber 0 g 0 g
Sugar 0 g 0 g
Protein 0 g 0 g
Vitamin A 0 mg 0 mg
Vitamin C 0 mg 0 mg
Calcium 1 mg 1 mg
Iron 0.2 mg 0 mg
Ash 0 g 0 g
Magnesium 0 mg 0 mg
Potassium 0 mg 0 mg
Moisture 3 g 3 g

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.