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, Antibiotics-free, BSE-free, Bisphenol Derivatives-free, CMR Substances-free, Caffeine Free, Diethylene Glycol-free, Dioxane-free, Dye Free, Endocrine Disruptor-free, Ethylene Glycol-free, Ethylene Oxide-free, Fragrance allergen-free, Fungicide-free, Gluten-free, Glycerin-free, Halal, Herbicide-free, Hormones-free, Iodide-free, Kosher, Latex-free, Monosodium Glutamate (MSG)-free, Natural Latex Rubber-Free, Non-GMO, 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, 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), EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA 21 CFR 117, FDA Compliant, FDA Food Safety Modernization Act (FSMA), Generally Recognized As Safe (GRAS), Halal, ICH Q3C, Japan Pharmacopeia (JP), Kosher, Nagoya Compliant, National Formulary (NF), United States Pharmacopeia (USP), cGMP

Manufacturing Technology: Direct Compression, Dry Granulation, Wet Granulation

Synonyms: Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose

  • TypeDocument Name
View All Documents

Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
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

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.