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Pharmaceutical-Grade Ethyl Cellulose

Ethyl cellulose is a cellulose derivative in which some hydroxyl groups are replaced by ethyl groups, making it soluble in organic solvents. It is a useful film-forming agent, adhesive, and thickener. Due to its film-forming properties, thermoplasticity, and hydrophobicity, it is widely used in various fields, including pharmaceuticals, food, and specialty coatings.

Chemical Name :
Ethyl Cellulose
Application :
Sustained-release formulation matrix materials, coating materials, microcapsule materials, adhesives, drug carriers, and backing materials, etc.
Appearance :
White powder
brand :
Kabasph

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product introduction

Ethyl Cellulose (EC) is an organic solvent-based cellulose ether primarily derived from natural cellulose through chemical processing. The product is odorless, white to light yellow powder or granules. It has a bulk density of 0.2–0.4 g/cm³, a density of 1.14 g/cm³, and a softening point of 135–155°C.

Ethyl cellulose is a widely used important pharmaceutical excipient in the preparation of drug formulations, characterized by excellent thickening properties, binding properties, film-forming properties, thermoplastic properties, compatibility, physical stability, chemical stability, and non-toxicity. It is extensively used in both oral and topical formulations, serving as a matrix material for sustained-release formulations, coating material, microcapsule material, adhesive, drug carrier, and backing material, among other applications.

Product name: Ethyl Cellulose

CAS No.: 9004-57-3

MF: C23H24N6O4

MW: 448.47446

EINECS.No: 618-384-9

Appearance: White Powder

Specifications

Item	EC-K4	EC-K7	EC-K10	EC-K20	EC-K35	EC-K50	EC-K70	EC-K100	EC-K200	EC-K300
Ethoxy content (%)	44.0-47.4
Characteristics	White or off-white granules or powder
	Soluble in dichloromethane, slightly soluble in ethyl acetate, insoluble in water, glycerol, or propylene glycol.
Identification	The infrared absorption spectrum is consistent with that of the reference substance.
Viscosity (1:4 ethanol-toluene solvent, 5%, 25°C) mPs	3.0-5.6	5.6-8.4	8.0-12.0	16.0-24.0	28-42	40-60	56-84	80-120	160-240	240-360
PH	0.1
Chloride ≤	0.01
Acetaldehyde, % ≤	3
Loss on drying, % ≤	0.4
Residue on ignition, % ≤	3
Heavy metals, % ≤	0.001
Arsenic salts, % ≤	0.0003
Note: Product specifications comply with the current Chinese Pharmacopoeia, United States Pharmacopoeia, and European Pharmacopoeia.

Item	EC-N4	EC-N7	EC-N10	EC-N20	EC-N35	EC-N50	EC-N70	EC-N100	EC-N200	EC-N300
Ethoxy content (%)	47.5-49.5
Characteristics	White or off-white granules or powder
	Soluble in dichloromethane, slightly soluble in ethyl acetate, insoluble in water, glycerol, or propylene glycol.
Identification	The infrared absorption spectrum is consistent with that of the reference substance.
Viscosity (1:4 ethanol-toluene solvent, 5%, 25°C) mPs	3.0-5.6	5.6-8.4	8.0-12.0	16.0-24.0	28-42	40-60	56-84	80-120	160-240	240-360
PH	0.1
Chloride ≤	0.01
Acetaldehyde, % ≤	3
Loss on drying, % ≤	0.4
Residue on ignition, % ≤	3
Heavy metals, % ≤	0.001
Arsenic salts, % ≤	0.0003
Note: Product specifications comply with the current Chinese Pharmacopoeia, United States Pharmacopoeia, and European Pharmacopoeia.

Microbial limit

Item	Specification
Total aerobic bacteria count, CFU/g ≤	103
Total mold and yeast count, CFU/g ≤	102
Staphylococcus aureus, CFU/g	Not detected Pass
Pseudomonas aeruginosa, CFU/g	Not detected Pass
Escherichia coli, CFU/g	Not detected Pass
Note: Solvent residues comply with the Chinese Pharmacopoeia 2020 Edition. Chinese Pharmacopoeia Part IV 1107 Microbial Limits for Non-Sterile Drugs (P171) Explanation: 103cfu: The maximum acceptable average is 2000, 102cfu: The maximum acceptable average is 200.

Solvent residue index

Item	Specification
Toluene, %≤	0.089
Ethanol, % ≤	0.5
Ether, %≤	0.5
Note: Solvent residues comply with the Chinese Pharmacopoeia 2020 Edition. Physical and chemical technical indicators are tested for each batch upon delivery. Microbial limits and solvent residue indicators are tested according to user formulation requirements.

Product Application Recommendations

Application	Recommended model
Sustained-release skeleton	EC-N7,EC-N10,EC-N20
Drug coating	EC-N7,EC-N10,EC-N20
Microcapsule	EC-N20,EC-N50,EC-N100
Granulation	EC-N10,EC-N20,EC-N50
Adhesive	EC-N7,EC-N10,EC-N100
Backing material	EC-N50,EC-N100
Note: Depending on the specific technical requirements of the user's application, the recommended models are not limited to those listed above.

Pharmaceutical-Grade Ethyl Cellulose

Packaging

The packaging consists of an inner layer of polyethylene plastic film bag and an outer layer of composite paper bag or paper drum; each piece weighs 10 kg, 12.5 kg, or 20 kg net.

Storage and Transportation

During transportation, take precautions against rain, sunlight, and hooks. Store in a sealed, dry place, take precautions against moisture, and do not mix with other chemicals. Do not mix, transport, or store the product with toxic, harmful, or odorous goods.

Safety

According to EU regulations on hazardous substances, Ethyl Cellulose is classified as a non-hazardous substance. Dust formation and accumulation should be avoided. Spilled product should be swept up while keeping it dry, as contact with water may cause slipping hazards. For complete product safety information, please refer to the MSDS (Material Safety Data Sheet). Detailed MSDS can be obtained by contacting our company personnel.

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Industrial-Grade Ethyl Cellulose

Ethyl Cellulose (or ethylcellulose) is a derivative of cellulose in which some of the hydroxyl groups on the repeating glucose units are converted into ethyl ether groups.It is soluble in organic solvents and is a useful film-forming agent, adhesive, and thickener. Due to its film-forming properties, thermoplasticity, and hydrophobicity, it is widely used in various fields, including pharmaceuticals, food, and specialty coatings.

Pharmaceutical-Grade Ethyl Cellulose

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