Polyethylene Glycol 400 (PEG 400)

Polyethylene Glycol 400 (PEG 400)：

Polyethylene Glycol 400 is a low molecular weight grade of polyethylene glycol, supplied as a clear, hygroscopic liquid produced via catalyzed ethoxylation of ethylene oxide and water. It exhibits complete water solubility, low systemic toxicity, and compatibility with diverse polar and non-polar raw materials. Designed for continuous industrial and pharmaceutical processing, our PEG 400 complies with major global pharmacopeial standards to ensure reproducible performance in active formulation lines.

 

Product Specifications：

CAS Number	25322-68-3
Molecular Weight	380 - 420 g/mol
Appearance	Clear, colorless viscous liquid
pH (5% aqueous solution)	4.5 - 7.5
Water Content (Karl Fischer)	<= 1.0%
Viscosity (20 deg C)	105 - 130 mm2/s
Hydroxyl Value	264 - 300 mg KOH/g
Ethylene Glycol & Diethylene Glycol	<= 0.25% combined

 

Chemical & Physical Properties：

Density (20 deg C): 1.12 - 1.14 g/cm3

Flash Point: > 190 deg C (Closed Cup)

Solubility: Miscible in water, lower alcohols, acetone, and glycols; insoluble in aliphatic hydrocarbons, petroleum ether, and fixed oils.

Hygroscopicity: Readily absorbs moisture from ambient air; requires nitrogen blanketing during bulk storage to prevent dilution and peroxide development.

 

Applications：

Pharmaceutical Formulation: Acts as a liquid vehicle, co-solvent, and plasticizer for soft gelatin capsules, oral liquid suspensions, and topical ointments. Modulates active pharmaceutical ingredient (API) release profiles and improves dissolution rates of poorly water-soluble compounds.

Cosmetics & Personal Care: Functions as a humectant, binder, and viscosity regulator in facial creams, body lotions, oral hygiene preparations, and surfactant systems.

Industrial Manufacturing: Utilized as an intermediate in polyurethane resin production, a mold-release agent for elastomers, an antistatic agent in paper processing, and a lubricity additive in metalworking fluids.

 

Pharmaceutical Manufacturing Relevance：

Meets USP-NF and Ph. Eur. monograph standards. Controlled molecular weight distribution prevents phase separation in multi-ingredient liquid formulations and ensures consistent droplet size distribution in metered-dose systems. Low residual ethylene oxide and heavy metal profile eliminates reactivity risks with sensitive pharmaceutical APIs.

 

Grade & Quality Requirements:

Compendial Compliance: Fully compliant with USP-NF and Ph. Eur. specifications.

Regulatory Registrations: Full EU REACH registration in place for direct import into the European Union.

Regulatory Certifications: Kosher and Halal certified.

Dietary & Safety Profile: Non-GMO, allergen-free, and free from animal-derived raw materials, satisfying strict clean-label standards.

 

Quality Control:

Every production lot is released under strict analytical testing protocols:

lViscosity quantified using calibrated capillary viscometers at 20 deg C.

lMolecular weight calculated via hydroxyl value titration per ASTM D4274.

lHeavy metals monitored below 5 ppm via atomic absorption spectrophotometry.

lMonomer impurities (ethylene glycol and diethylene glycol) quantified via gas chromatography (GC) to guarantee compliance below the 0.25% threshold.

 

Technical Documents:

COA (Certificate of Analysis): Provided for every manufactured batch, detailing actual laboratory test results against specification parameters.

SDS (Safety Data Sheet): GHS-compliant hazard, handling, and spill response data.

TDS (Technical Data Sheet): Complete physical metrics, handling limits, and application baselines.

 

Packaging & Storage:

Packaging Configurations:

l230 kg lined carbon steel or food-grade HDPE drums

l1,000 kg UN-approved composite IBC totes

lDedicated ISO tank containers for bulk liquid distribution

Storage Protocol: Store in tightly sealed containers in a dry, well-ventilated location away from strong oxidizing agents. Shelf life is 24 months from manufacture date when stored below 30 deg C in unopened containers.

 

Supply & Procurement:

MOQ (Minimum Order Quantity): 1 Pallet (4 x 230 kg drums / 920 kg) for drum orders; 1 ISO tank (approx. 20 - 24 metric tons) for bulk delivery.

Sample Policy: 500 mL laboratory analytical samples dispatched upon request for formulation testing.

Lead Time: 7 to 14 business days for standard sea freight container shipments; immediate dispatch from regional inventory for contracted recurring orders.

Bulk Supply: Supported by annual volume contracts, fixed-price agreements, and dedicated tank truck delivery schedules.

 

OEM / Custom Specification:

Custom hydroxyl value bands, narrowed molecular weight distributions, and ultra-low moisture limits (<= 0.5%) can be accommodated for dedicated production campaigns. Private-label documentation packages and custom drum stenciling are available for registered chemical distributors.

 

 

Request a Quote：

Submit required annual volume, destination port, and desired documentation package (USP/EP) to receive a formal commercial quotation within 24 business hours.

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