Aquacoat® ECD - 30 containing ethylcellulose, is a liquid formulation utilized for tablet coating. With labeling claims of being palm oil-free, glycerin-free, and endocrine disruptor-free, it serves as a controlled release agent, enteric coating system, sustained release agent, and taste masking agent in pharmaceutical and nutraceutical applications.

Chemical Name: Ethylcellulose

Dosage Form: Tablets

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Amine-free, Antibiotics-free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Ethylene Oxide-free, GMO-free, Generally Recognized As Safe (GRAS), Genotoxic-free, Glycerin-free, Halal, Heavy Metal-free, Hormones-free, Kosher, Latex-free, Melamine-free, Monosodium Glutamate (MSG)-free, Nanomaterials-free, Natural Latex Rubber-Free, Nitrosamines-free, Non-GMO, Not Listed In California Proposition 65, 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, Plasticizer-free, Preservative-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, Vegan, Vegetarian

Certifications & Compliance: British Pharmacopeia (BP), Chinese Pharmacopeia (ChP), Doping-Free, EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA 21 CFR Regulations, FDA Compliant, FDA Food Safety Modernization Act (FSMA), GMP, Japan Pharmacopeia (JP), Nagoya Compliant, National Formulary (NF), Regulation (EU) No. 231/2012, United States Pharmacopeia (USP), cGMP

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

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Drying68.0 - 71.0--
Ethyl Cellulose24.5 - 29.5%-
Sodium Lauryl Sulfate0.9 - 1.7%-
Cetyl Alcohol1.7 - 3.3%-
IdentificationPass--
Heavy Metalsmax. 0.001%-
Specific Gravity1.025 - 1.040--
pH4.0 - 7.0--
Viscositymax. 150cPs-
Exthoxyl Content48.0 - 49.5%-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 100cfu/g-
Yeast and Mold Countmax. 20cfu/g-
Pseudomonas aeruginosaAbsent/10g-
E. coliAbsent/10g-
Staphylococcus aureusAbsent/10g-
Salmonella SpeciesAbsent/10g-
Note

This product meets the requirements of the NF and JPE for Ethylcellulose Aqueous Dispersion. Manufactured under GMP’s and Issued by IFF Nutrition USA, 1301 Ogletown Road, Newark,Delaware
19711 USA. The product is in substantial compliance with the requirements for Bulk Pharmaceutical Excipient GMP as developed by IPEC America and also published in the USP General as Chapter <1078>.
IFF has characterized Aquacoat ECD as Generally Recognized as Safe (GRAS) for use as a coating in dietary supplements in accordance with the Federal Food, Drug and Cosmetic Act.

Regulatory & Compliance

Technical Details & Test Data

Typical Nutrient Information/100g
  US EU/Australia/NZ
Total calories 60.2 Cal 60.2 Cal
Calories from fat 0.5 Cal 0.5 Cal
Total Fat 0.05 g 0.05 g
Saturated Fat 0.02 g 0.02 g
Sodium 2.9 mg 2.9 mg
Total carbohydrates 30.1 g 0 g
Sugars < 1.0 g < 1.0 g
Total dietary fiber 0 g 30.1 g
Protein < 0.10 g < 0.10 g
Vitamin A 89.1 lU 89.1 lU
Vitamin C < 0.44 mg < 0.44 mg
Calcium < 4 mg < 4 mg
Iron < 1.0 mg < 1.0 mg
Magnesium 0 g 0 g
Moisture* 69.48 g 69.48 g
Ash* 0.30 g 0.30 g

US: Calories = [(Total Carbs + Protein) * 4 Cal/g + (Fat * 9 Cal/g)]. Soluble fiber ais included in Total Carbs, but calorie contribution is calculated at 2 Cal/g. In the US, food manufacturers have the option to exclude the amount of insoluble fiber from the calorie calculation.
EU: Calories = ([Carbs (sugars + starch ) + Protein] * 4 Cal/g) + (Fat * 9 Cal/g) + (All dietary fiber * 2 Cal/g) + (Organic acids * 3 Cal/g)). In Europe, fiber is listed separately and is not included in the carb content. Other calorie conversion factors exist, none of which is relevant to this product.

Storage & Handling

Shelf Life
2 years
Shelf Life Information

Keep tightly closed. Store at approximately 20°C (68°F). Protect from freezing. Do not expose to temperatures above 35°C (95°F). Re-evaluation date is two years from date of manufacture, if storage conditions stated above are observed.