Avicel® PH - 301

1 of 18 products in this brand
Avicel® PH - 301 is a multifunctional ingredient utilised in various pharmaceutical applications, including granules, suspensions, and tablets. It acts as a binder, compression aid, filler, and immediate release agent, streamlining the manufacturing process and ensuring consistent product quality. This versatile component enhances formulation efficiency and contributes to the development of high-performance pharmaceutical products.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

Dosage Form: Granules, Suspension, Tablets

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Amine-free, Animal Products-free, Antibiotics-free, BSE-free, Bisphenol Derivatives-free, CMR Substances-free, Caffeine Free, Dehp (Diethylhexyl Phthalate)-Free, Diethylene Glycol-free, Dioxane-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Ethylene Glycol-free, Ethylene Oxide-free, Flavor Free, Fragrance allergen-free, Free of Major Allergens, Fungicide-free, Generally Recognized As Safe (GRAS), Genotoxic-free, Gluten-free, Glycerin-free, Halal, Herbicide-free, Hormones-free, Impurities-free, Iodide-free, Irradiation-free, Kosher, Latex-free, Melamine-free, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Nitrosamines-free, Non-GMO, Not Tested on Animals, PAH-free, PFAS-Free, PFOA-free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Pesticide-free, Phthalates-free, Plasticizer-free, Potassium-free, Preservative-free, Quaternary Ammonium Salt-Free, Solvent-free, Sugar-free, TSE-free, Tributyltin (TBT) - Free, Vegan, Vegetarian

Certifications & Compliance: ABNT NBR 14725, Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), Chinese Pharmacopeia (ChP), Directive 1169/2011/EC, EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA 21 CFR 117, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, Halal, Central Islamic Council of Thailand, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, ISO 14001, ISO 22000, ISO 45001, ISO 9001, JECFA (FAO/WHO), Japan Pharmacopeia (JP), Kosher, Nagoya Compliant, National Formulary (NF), Orthodox Union Kosher, Regulation (EC) No. 1334/2008, Regulation (EU) No. 1829/2003, Regulation (EU) No. 1830/2003, Regulation (EU) No. 1881/2006, Regulation (EU) No. 231/2012, Union of Orthodox Jewish Congregations of America Kosher, 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
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,
Animal Products-free,
Antibiotics-free,
BSE-free,
Bisphenol Derivatives-free,
CMR Substances-free,
Caffeine Free,
Dehp (Diethylhexyl Phthalate)-Free,
Diethylene Glycol-free,
Dioxane-free,
Dioxin-free,
Dye Free,
Endocrine Disruptor-free,
Ethylene Glycol-free,
Ethylene Oxide-free,
Flavor Free,
Fragrance allergen-free,
Free of Major Allergens,
Fungicide-free,
Generally Recognized As Safe (GRAS),
Genotoxic-free,
Gluten-free,
Glycerin-free,
Halal,
Herbicide-free,
Hormones-free,
Impurities-free,
Iodide-free,
Irradiation-free,
Kosher,
Latex-free,
Melamine-free,
Monosodium Glutamate (MSG)-free,
Mycotoxins-free,
Natural Latex Rubber-Free,
Nitrosamines-free,
Non-GMO,
Not Tested on Animals,
PAH-free,
PFAS-Free,
PFOA-free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-free,
Palm Oil-free,
Paraben-free,
Pesticide-free,
Phthalates-free,
Plasticizer-free,
Potassium-free,
Preservative-free,
Quaternary Ammonium Salt-Free,
Solvent-free,
Sugar-free,
TSE-free,
Tributyltin (TBT) - 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
Granules,
Suspension,
Tablets
Manufacturing Technology
Direct Compression,
Dry Granulation,
Wet Granulation

Properties

Physical Form
Powder
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

Certifications & Compliance
ABNT NBR 14725,
Belgian Law And Codex Alimentarius Standards,
British Pharmacopeia (BP),
Chinese Pharmacopeia (ChP),
Directive 1169/2011/EC,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FDA 21 CFR 117,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
FSSC 22000,
GMP,
Generally Recognized As Safe (GRAS),
Halal,
Halal, Central Islamic Council of Thailand,
Hazard Analysis Critical Control Point (HACCP),
ICH Q3C,
ISO 14001,
ISO 22000,
ISO 45001,
ISO 9001,
JECFA (FAO/WHO),
Japan Pharmacopeia (JP),
Kosher,
Nagoya Compliant,
National Formulary (NF),
Orthodox Union Kosher,
Regulation (EC) No. 1334/2008,
Regulation (EU) No. 1829/2003,
Regulation (EU) No. 1830/2003,
Regulation (EU) No. 1881/2006,
Regulation (EU) No. 231/2012,
Union of Orthodox Jewish Congregations of America Kosher,
United States Pharmacopeia (USP),
cGMP
Quality Standards
EN ISO 9001:2015,
ISO 22000

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.