PEG 400 (Polyethylene Glycol 400 or Macrogol 400) is an ethylene oxide polymer widely used in the pharmaceutical and cosmetic industries. Unlike high-molecular-weight PEGs that exist in solid forms, PEG 400 is a clear, viscous liquid. It serves as a highly effective solvent, co-solvent, and bioavailability enhancer for active pharmaceutical ingredients (APIs) that are poorly soluble in water. In particular, PEG 400 is an indispensable component in the formulation of soft gelatin capsules (softgels) and oral liquid dosage forms.
The raw material is manufactured by Nitika Pharmaceutical Specialities Pvt. Ltd. (India), one of the leading and most reputable excipient manufacturers in India. Utilizing modern production lines and strict quality management systems, Nitika's PEG 400 achieves optimal purity and complies with international pharmacopoeia standards, ensuring high safety, stability, and excellent compatibility in all formulations.
Material Name: PEG 400 / Polyethylene Glycol 400 / Macrogol 400.
Manufacturer: Nitika Pharmaceutical Specialities Pvt. Ltd.
Origin: India.
Material Category: Pharmaceutical Excipient.
Function: Solvent, co-solvent for solubility enhancement, humectant, softgel capsule vehicle, and carrier for topical formulations.
Chemical Composition: A polymer of ethylene oxide and water, with an average molecular weight of approximately 400.
Form: Slightly viscous, clear, colorless or almost colorless liquid. It is hygroscopic (absorbs moisture).
Solubility: Completely soluble in water, ethanol, acetone, and other glycols; insoluble in fatty ethers and mineral oils.
Quality Standards: Complies with strict international pharmacopoeia standards such as USP, BP, and EP.
The material is strictly controlled for:
Molecular Weight: Ensures a standard molecular weight distribution ranging from 380 to 420.
Purity and Safety: Strict control of related impurities, free ethylene oxide, 1,4-dioxane, and heavy metal limits, ensuring absolute safety.
Stability Indicators: Strict monitoring of pH and moisture levels to prevent any adverse impact on the stability of the active ingredients (APIs) when formulated together.
Superior Solubilizing Capability: PEG 400 is an excellent solvent that helps dissolve a wide range of poorly water-soluble active ingredients, significantly improving drug absorption rates and bioavailability.
High Compatibility with Softgels: It does not interact negatively with gelatin capsule shells, preventing them from becoming brittle or cracking during long-term storage.
High Biosafety Profile: It causes minimal irritation to the skin and mucous membranes, possesses very low toxicity, and is well-tolerated when used orally, topically, or even in certain injectable formulations.
International Standard Quality: Produced at Nitika's GMP-certified plant in India, ensuring consistent purity that meets global pharmaceutical manufacturing standards.
In Pharmaceuticals (Core Applications)
Soft Gelatin Capsules (Softgels): Serves as the liquid base/vehicle to dissolve the active drug inside the softgel shell (e.g., liquid-filled Ibuprofen capsules).
Oral Solutions & Syrups: Functions as a co-solvent to help the active ingredients disperse evenly and remain stable in the solution.
Topical Medications: Applied as an excipient in ointments, creams, gels, eye drops, and ear drops due to its emollient and moisture-retaining properties.
In Health Supplements and Cosmetics
Healthcare Products: Used as a carrier in softgel capsules containing vitamins and herbal extracts.
Cosmetics: Acts as a humectant, solvent, and viscosity modifier in lotions, body washes, and toothpaste.
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For more information about the supply chain, technical specifications of PEG 400, or to place an order, please contact us:
Consultation Hotline: +84 (0) 834 560 500
Email: director@biorichgroup.com
Website:www.biorichgroup.com
Sample/COA Request: Please contact us via email to request samples and the latest Certificate of Analysis (COA) for the material from the manufacturer, Nitika Pharmaceutical Specialities Pvt. Ltd.
