Avicel® CE-15

1 of 18 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, Aflatoxin-free, Allergen-free, Aluminum-free, Amine-free, Animal Products-free, Antibiotics-free, Artificial Flavor-Free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dehp (Diethylhexyl Phthalate)-Free, Dioxin-free, Dye Free, Flavor Free, Free of Major Allergens, Generally Recognized As Safe (GRAS), Genotoxic-free, Gluten-free, Halal, Hormones-free, Irradiation-free, Kosher, Latex-free, Melamine-free, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Nitrosamines-free, Non-GMO, Not Engineered With Nanomaterials, Not Tested on Animals, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Paraben-free, Perchlorate-free, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plasticizer-free, Preservative-free, Solvent-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, Vegan, Vegetarian

Certifications & Compliance: British Pharmacopeia (BP), Chinese Pharmacopeia (ChP), Directive 1169/2011/EC, Directive 1895/2005/EC, EC No. 1935/2004, EC No. 2023/2006, EU Cosmetic Regulation 1223/2009 Compliant, EU Directive 2002/72/EC, EXCiPACT, European Pharmacopeia (Ph. Eur.), FCC Compliant, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FSSC 22000, GMP, Halal, Central Islamic Council of Thailand, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, IFANCA Halal, IFRA Compliant, ISO 14001, ISO 22000, ISO 45001, ISO 9001, JECFA (FAO/WHO), Japan Pharmacopeia (JP), National Formulary (NF), Orthodox Union Kosher, Regulation (EC) No. 1334/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, 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

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,
Aflatoxin-free,
Allergen-free,
Aluminum-free,
Amine-free,
Animal Products-free,
Antibiotics-free,
Artificial Flavor-Free,
BSE-free,
Bisphenol A-free,
Caffeine Free,
Colorants-free,
Dehp (Diethylhexyl Phthalate)-Free,
Dioxin-free,
Dye Free,
Flavor Free,
Free of Major Allergens,
Generally Recognized As Safe (GRAS),
Genotoxic-free,
Gluten-free,
Halal,
Hormones-free,
Irradiation-free,
Kosher,
Latex-free,
Melamine-free,
Monosodium Glutamate (MSG)-free,
Mycotoxins-free,
Natural Latex Rubber-Free,
Nitrosamines-free,
Non-GMO,
Not Engineered With Nanomaterials,
Not Tested on Animals,
PAH-free,
PFAS-Free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-free,
Paraben-free,
Perchlorate-free,
Perfluorooctanoic Acid-free,
Pesticide-free,
Phthalates-free,
Plasticizer-free,
Preservative-free,
Solvent-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
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),
Chinese Pharmacopeia (ChP),
Directive 1169/2011/EC,
Directive 1895/2005/EC,
EC No. 1935/2004,
EC No. 2023/2006,
EU Cosmetic Regulation 1223/2009 Compliant,
EU Directive 2002/72/EC,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FCC Compliant,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
FSSC 22000,
GMP,
Halal, Central Islamic Council of Thailand,
Hazard Analysis Critical Control Point (HACCP),
ICH Q3C,
IFANCA Halal,
IFRA Compliant,
ISO 14001,
ISO 22000,
ISO 45001,
ISO 9001,
JECFA (FAO/WHO),
Japan Pharmacopeia (JP),
National Formulary (NF),
Orthodox Union Kosher,
Regulation (EC) No. 1334/2008,
Regulation (EU) No. 10/2011 (PIM),
Regulation (EU) No. 1169/2011,
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
Chemical Inventories
ENCS (Japan)
Quality Standards
EN ISO 9001:2015,
ISO 22000

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.