Avicel® CE-15

1 of 16 products in this brand
Avicel® CE-15 a non-animal-derived ingredient, is widely employed in tablet production. It's adaptable to various manufacturing methods like direct compression, dry granulation, and wet granulation. In pharmaceutical and nutraceutical applications, it acts as a binder, compression aid, filler, immediate release agent, and suspension aid. It's supplied in powder form for easy tablet formulation.

Chemical Name: Calcium Hydrogen Phosphate, Cellulose, Microcrystalline, Guar Gum

Dosage Form: Soft Chews, Tablets

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Antibiotics-free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Generally Recognized As Safe (GRAS), Halal, Hormones-free, Kosher, Latex-free, Monosodium Glutamate (MSG)-free, Natural Latex Rubber-Free, Non-GMO, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-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), EU Cosmetic Regulation 1223/2009 Compliant, EXCiPACT, European Pharmacopeia (Ph. Eur.), FCC Compliant, FDA Compliant, FDA Food Safety Modernization Act (FSMA), Generally Recognized As Safe (GRAS), ICH Q3C, IFRA Compliant, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP), cGMP

Manufacturing Technology: Direct Compression, Dry Granulation, Wet Granulation

Technical Data SheetSafety Data SheetBrochure
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Enhanced TDS

Identification & Functionality

Chemical Family
Cellulose & Cellulosics,
Phosphates,
Polysaccharides
Chemical Name
Calcium Hydrogen Phosphate,
Cellulose, Microcrystalline,
Guar Gum
Ingredient Origin
Non-Animal Origin
Pharma & Nutraceuticals Functions
Binder,
Compression Aid,
Filler,
Immediate Release Agent,
Suspending 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,
Generally Recognized As Safe (GRAS),
Halal,
Hormones-free,
Kosher,
Latex-free,
Monosodium Glutamate (MSG)-free,
Natural Latex Rubber-Free,
Non-GMO,
PAH-free,
PFAS-Free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-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
Healthcare & Pharma — Pharmaceutical Manufacturing
Pharmaceutical Processing
Segments
Dietary Supplement,
Pharmaceutical
Applications
Pharmaceutical — Immediate release
Dietary Supplement — Immediate release
Dosage Form
Soft Chews,
Tablets
Manufacturing Technology
Direct Compression,
Dry Granulation,
Wet Granulation

Properties

Physical Form
Powder
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
IdentificationPass-Infrared
Loss on Dryingmax. 8.0%-
Heavy Metalsmax. 0.001%-
Particle Size (325 mesh, 45 microns)max. 80wt%-
pH (at 5% solids)4.0 - 7.0--
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 1000cfu/g-
Yeast and Mold Count (Total)max. 100cfu/g-
Pseudomonas aeruginosaAbsent/10g-
E. coliAbsent/10g-
Staphylococcus aureusAbsent/10g-
Salmonella SpeciesAbsent/10g-
Note

This product meets the requirements for Residual Solvents in the United States Pharmacopeia <467> and complies with the ICH Guide Q3C for Residual Solvents.

Regulatory & Compliance

Certifications & Compliance
British Pharmacopeia (BP),
EU Cosmetic Regulation 1223/2009 Compliant,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FCC Compliant,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
Generally Recognized As Safe (GRAS),
ICH Q3C,
IFRA Compliant,
Japan Pharmacopeia (JP),
National Formulary (NF),
United States Pharmacopeia (USP),
cGMP
Chemical Inventories
ENCS (Japan)

Technical Details & Test Data

Typical Nutrient Information/100g
  US EU/Australia/NZ
Estimated Caloric Value 8 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 24 mg 24 mg
Salt - g 0.06 g
Potassium -- mg -- mg
Total Carbohydrate 96 g 0 g
Sugars (Total) 0 g 0 g
Added Sugars 0 g 0 g
Starch 0 g 0 g
Total Dietary Fiber 0 g 96 g
Dietary Fiber (Soluble) 3 g 3 g
Dietary Fiber (Insoluble) 93 g 93 g
Protein 0.5 g 0.5 g
Vitamin A 0 mcg 0 mcg
Vitamin C 0 mg 0 mg
Vitamin D 0 mcg 0 mcg
Calcium 5 mg 5 mg
Iron 0.6 mg 0.6 mg
Magnesium 0 mg 0 mg
Moisture 4 g 4 g
Ash 0.1 g 0.1 g
Organic acid -g 0 g

Storage & Handling

Shelf Life
3 years
Shelf Life Information

Store at ambient conditions. Keep containers sealed; material is very hygroscopic. Three (3) years from date of manufacture, if storage conditions stated above are observed. IFF recommends that after the above re- evaluation date, the customer perform the loss on drying and viscosity tests.