Avicel® PH - 101

1 of 16 products in this brand
Avicel® PH - 101 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, Odor-free, 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

Technical Data SheetSafety Data SheetBrochure
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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

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,
Odor-free,
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
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

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
AICS (Australia),
DSL (Canada),
EINECS (EU),
ELINCS (EU),
IECSC (China),
KECI (Korea),
NDSL (Canada)

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.