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, Amine-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, Impurities-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, Vegan, 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), FSSC 22000, Generally Recognized As Safe (GRAS), Halal, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, IFRA Compliant, ISO 22000, 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
  • TypeDocument Name
View All Documents

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,
Amine-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,
Impurities-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,
Vegan,
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),
FSSC 22000,
Generally Recognized As Safe (GRAS),
Halal,
Hazard Analysis Critical Control Point (HACCP),
ICH Q3C,
IFRA Compliant,
ISO 22000,
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)
Quality Standards
EN ISO 9001:2015

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.