ETHOCEL™ Standard 14 Premium Ethylcellulose

1 of 13 products in this brand
ETHOCEL™ Standard 14 Premium Ethylcellulose available in powder form, is adaptable for various manufacturing processes such as direct compression, encapsulation, and granulation. It exhibits ethanol solubility, offering versatility in pharmaceutical and industrial applications.

Chemical Name: Ethylcellulose

CAS Number: 9004-57-3

Dosage Form: Tablets

Labeling Claims: 1,4-Dioxane-free, APE-free, Aflatoxin-free, Allergen-free, Aluminum-free, Antibiotics-free, BSE-free, Bisphenol A-free, CMR Substances-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Formaldehyde-free, GMO-free, Glycerin-free, Halal, Hormones-free, Kosher, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, Nitrosamines-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, Plant-Based, Plasticizer-free, Preservative-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, Vegan, Vegetarian, Zero Calorie

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), CFDA Compliant (China), Canadian Environmental Protection Act (CEPA), Chinese Pharmacopeia (ChP), Clean Air Act (CAA) Certified, Directive 2023/915/EU, Doping-Free, EU Cosmetic Regulation 1223/2009 Compliant, EXCiPACT, EuPIA Listed, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA 21 CFR 163, FDA 21 CFR 172.868, FDA 21 CFR 181.24, FDA 21 CFR 573.420, FDA 21 CFR 73.1, FDA 21 CFR 73.1001, FDA Compliant, FDA Food Safety Modernization Act (FSMA), Generally Recognized As Safe (GRAS), Halal, ICH Q3C, ICH Q3D, Indian Pharmacopeia, Japan Chemical Substances Control Law (CSCL), Japan Pharmacopeia (JP), Kosher, Majelis Ulama Indonesia Halal, National Formulary (NF), Regulation (EC) No. 1333/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Regulation (EU) No. 1272/2008, Regulation (EU) No. 231/2012, RoHS 2 Compliant, RoHS Compliant, Swiss Ordinance (SR 817.023.21), Turkish RoHS Regulation, United States Pharmacopeia (USP), WEEE Directive 2012/19/EU, cGMP

Manufacturing Technology: Direct Compression, Encapsulation, Granulation, Hot Melt Extrusion, Tablet Coating

Synonyms: Cellulose ethyl, Cellulose ethylate, Ethyl cellulose ether, O-Ethylcellulose

  • TypeDocument Name
View All Documents

Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Typical Properties
ValueUnitsTest Method / Conditions
Identification*Pass-Current NF NF
Identification A*Pass-Current EP Test A - EP
Identification B*Pass-Current EP Test B - EP
Identification (1)*Pass-Current JP Test - JP
Identification (3)*Pass-Current FCC FCC
Residual Solvent*Pass-Current USP/EP/JP
Loss on Dryingmax. 2.0%Current USP Moisture
Residue on Ignitionmax. 0.40%Current USP/EP/JP
Viscosity (at 5%, solution)12.6 - 15.4mPa.sUbbelohde, Current NF
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCurrent USP
Pseudomonas aeruginosa*Absent/gCurrent USP
Salmonella*Absent/10gCurrent USP
Staphylococcus aureus*Absent/gCurrent USP
Yeast and Mold Count*max. 100/gCurrent USP Combined Mold and Yeast
Total Plate Count*max. 100/gCurrent USP Total Aerobic
Composition
ValueUnitsTest Method / Conditions
Acidity or Alkalinity*Pass-Current USP/EP/JP
Ethoxyl Content48.0 - 49.5%Current USP Assay
Chloride Content (as Sodium Chloride)max. 0.05%Current USP/EP/JP
Aldehydes*max. 100mg/KgCurrent USP/EP/JP
Heavy Metals
ValueUnitsTest Method / Conditions
Arsenic Content*max. 2mg/KgCurrent CHP
Heavy Metals (as Lead)*max. 10mg/KgCurrent JP Test - JP
Lead Content*max. 3mg/KgCurrent FCC
Note
  • All section names come under PHS.
  • The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.
  • Viscosity: 5% solution in 60/40 Toluene/Alcohol Mixture at 25°C.
  • Specification limits apply to the material as packaged in the original containers. They do not apply if the material has been repackaged, improperly stored, or if the package has been opened in an uncontrolled environment.
  • Audit Basis [AB]*

Regulatory & Compliance

Technical Details & Test Data

Nutritional Information

USA
Nutritional Information (Based on 100 grams)

Carbohydrates (g) 0
Non-Digestible Carbohydrates (g) 97.6
Water (g) 2
Ash (g) (includes salt and iron) 0.4
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

Additional Nutrient Information (Based on 100 grams)

Calories (Energy) (kcal) 0
Cholesterol (mg) 0
Total Dietary Fiber (g) 0
Soluble Fiber (g) 0
Insoluble Fiber (g) 97.6
Sugars (g) 0
Added Sugars (g) 0
Sodium (mg) 20
Chloride (mg) 30
Potassium (mg) 0
Magnesium (mg) 0
Iron (mg) 0
Zinc (mg) 0
Total Vitamin A (IU) 0
Vitamin C (mg) 0
Thiamin (mg) 0
Riboflavin (mg) 0
Vitamin D (IU) 0
Niacin (mg) 0
Vitamin B6 (mg) 0
Calcium (mg) 0
Phosphorus (mg) 0

The value for all other vitamins, minerals, and amino acids is ZERO for ETHOCELTM Ethylcellulose products. Data in the above tables are derived from internal laboratory analysis with the exception of carbohydrates, which were calculated.

European Union
Nutritional Information (per 100 g)

Energy

748 kJ / 187 kcal

Fat 0 g
Of which saturates 0 g
Carbohydrates 0 g
Of which sugars 0 g
Fibre 93.5 g
Protein 0 g
Salt 1.5 g

Australia and New Zealand
Food Standard Australia New Zealand (FSANZ) considers the energy value for unavailable carbohydrate (including dietary fiber) to be 8 kcal/g.

Australia & New Zealand
Nutritional Information (per 100 g)

Energy (kJ) 781
Carbohydrates (g) 0
Dietary Fibre (g) 97.6
Water (g) 2
Ash (g) (includes salt and iron) 1.5
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

Packaging & Availability

Packaging Type