Description

Polyoxyl 40 Hydrogenated Castor Oil USP/NF/EP

Polyoxyl 40 Hydrogenated Castor Oil USP/NF/EP is a high-purity, nonionic solubilizer and emulsifying agent widely used in pharmaceutical formulations to improve the solubility, stability, and bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs). Its broad regulatory acceptance and functional versatility make it a key excipient in parenteral, oral, ophthalmic, and topical dosage forms.

• It is compliant with USP, NF, and EP pharmacopeial standards
• It is a nonionic surfactant with excellent solubilizing and emulsifying capabilities
• It enhances aqueous solubility and bioavailability of hydrophobic drugs
• It is fully biocompatible for oral, injectable, ophthalmic, and topical applications

Polyoxyl 40 Hydrogenated Castor Oil is produced by the controlled ethoxylation of hydrogenated castor oil, resulting in a stable mixture of polyethylene glycol esters, ethers, and free polyethylene glycols. The compound typically contains approximately 40 moles of ethylene oxide per mole of hydrogenated castor oil, providing excellent hydrophilic-lipophilic balance (HLB) for use in diverse drug delivery systems.

In parenteral formulations, Polyoxyl 40 Hydrogenated Castor Oil serves as a solubilizing agent for poorly water-soluble drugs, such as ciclosporin, paclitaxel, and other lipophilic compounds. It stabilizes micelles and colloidal dispersions, preventing drug precipitation during storage and administration. In oral liquid and softgel formulations, it functions as a solubilizer and absorption enhancer, supporting high drug loadings while maintaining solution clarity and product stability.

In ophthalmic and topical preparations, Polyoxyl 40 Hydrogenated Castor Oil acts as an emulsifier and stabilizer, improving spreadability, clarity, and patient tolerance. Its nonionic nature minimizes irritation and enhances compatibility with sensitive mucosal tissues.

Pharmaceutical developers and procurement teams seeking to purchase Polyoxyl 40 Hydrogenated Castor Oil USP/NF/EP benefit from CarboMer’s validated manufacturing processes, tight process control, and global regulatory support for drug product development, registration, and commercialization.

The material is supplied in sealed, tamper-evident, moisture-controlled packaging to preserve integrity during storage and transport. Minimum order quantities (MOQ), lead times, and full technical data packages are available for preclinical, clinical, and commercial manufacturing programs.

Each production batch undergoes comprehensive quality control testing, including assays for hydroxyl value, acid value, saponification value, residual ethylene oxide, peroxide levels, microbial purity, and compliance with USP, NF, and EP pharmacopeial monographs.

As with all CarboMer excipients, Polyoxyl 40 Hydrogenated Castor Oil USP/NF/EP is fully supported by technical formulation assistance, regulatory consultation, and lifecycle management services to accelerate development timelines and ensure regulatory success globally.