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Polyoxyethylene 60 Hydrogenated Castor Oil, often known in technical circles as PEG-60 Hydrogenated Castor Oil, has carved an important niche among pharmaceutical excipients. This compound emerges from the reaction of castor oil, a time-tested raw ingredient, with hydrogen to saturate its fatty acids, followed by ethoxylation. The result is a nonionic surfactant prized for its balance of hydrophilic and lipophilic character. Many colleagues describe this material as a bridge between water and oil, a crucial player in creating stable emulsions in everything from intravenous solutions to topical creams. Its synthesis produces a substance recognized by pharmacopoeias under the specifications BP, EP, and USP, ensuring global acceptance and reliable quality. The HS Code for importing and exporting purposes most commonly aligns with 3402.13, a signpost for regulatory managers and customs officers.
Polyoxyethylene 60 Hydrogenated Castor Oil appears in several forms, each with specific handling requirements. Flecks of white or off-white solid, flakes, powdery pearls, and even viscous liquid are all methods packagers use to send this compound from manufacturer to user. Often, the powder and pearl forms show up in dry-blending operations, especially where dust minimization and accurate dosing matter. Sometimes, as a viscous liquid or soft mass, it can pour directly into solution tanks, simplifying mixing in process scale runs. The crystalline aspect is subtle, not prominent as with sugars or salts, but still visible to a practiced eye. Its density typically falls between 1.05-1.10 g/cm3 at room temperature, a sweet spot that means it settles easily in aqueous preparations but does not swamp lighter excipients.
Chemically, this surfactant carries a backbone derived from castor oil, modified with hydrogen atoms to improve stability, and ethoxylated with about 60 units of ethylene oxide. That creates repeating –CH2CH2O– links, each one grabbing onto water molecules and helping blend otherwise immiscible materials. The general molecular formula is often written as C64H126O29. This skeleton underpins everything from solubility to interaction with active pharma ingredients. Its hydrophilic-lipophilic balance (HLB) value typically lands around 15-16, speaking to its skill at making water and oil coexist. As someone who’s tried to disperse stubborn oil-based actives, I’ve seen firsthand that proper use of materials like PEG-60 Hydrogenated Castor Oil smooths out stubborn clumping and cuts processing time.
Pharmaceutical specifications call for consistent high purity, usually above 99%, and precise control of residual chemicals—no more than trace amounts of unreacted castor oil or ethylene oxide. The melting range hovers between 30°C to 40°C, important for those running heated process tanks yet wanting the material to set up at room temperature in finished products. Viscosity varies by batch and form, but falls within workable limits for both manual and automated processing. Water content generally sits below 1.5%, critical in environments where moisture drags down shelf life or interferes with active ingredients.
In the day-to-day, safety remains a top concern. Polyoxyethylene 60 Hydrogenated Castor Oil earns a reputation for being safe, non-carcinogenic, and not acutely toxic when handled correctly in pharma settings. Still, any chemical with significant surfactant action deserves respect—improper use can cause skin and eye irritation, so gloves and goggles are standard procedure. The substance rates low on the hazard scale compared to stronger detergents or industrial surfactants, but Material Safety Data Sheets note the importance of avoiding inhalation of dust from powdered forms. Disposal shouldn’t be casual; regulatory agencies set clear guidelines on safe release to wastewater treatment. In pharma I’ve seen the impact of even small oversights—proper containment, labeling, and training aren’t just box-checking paperwork.
This ingredient shows up most often as an emulsifier and solubilizer. I can recall several projects where it transformed cloudy active compounds into clear, shelf-stable injectables, shaving weeks off reformulation timelines. In solid dose, topical, and oral liquid form, its action directly raises bioavailability for certain poorly soluble drugs. Because it complies with BP, EP, and USP standards, regulatory teams can press toward product launches in a wide geography without reformulating. This versatility turns Polyoxyethylene 60 Hydrogenated Castor Oil into more than a technical excipient—it’s a strategic asset in fast-moving development projects.
The base material—castor oil—mainly comes from castor beans, a resource grown in countries like India, Brazil, and China. The hydrogenation and ethoxylation phases add industrial complexity, but most reputable suppliers use closed systems that keep operator exposure and emissions to a minimum. With sustainability gaining focus in pharmaceutical sourcing, responsible manufacturers are putting effort into traceability for the oils and safe handling for the ethylene oxide feeds. Working with suppliers that publish data on supply chain integrity and emission controls brings clear peace of mind, especially as audits grow more robust.
Challenges still surface. Some in the industry worry about residual impurities from ethoxylation, though published data from reliable labs put these well below toxic thresholds. Other discussions revolve around greener alternatives or chemical pathways—no silver bullets yet, though research into bio-based surfactants is picking up steam. Average users and process managers can help by demanding third-party tested lots, asking for transparent CoAs, and sharing field data with suppliers to tighten controls further. Smart documentation and ongoing evaluation of alternatives will keep end users and patients both safe and informed.
Chengguan District, Lanzhou, Gansu, China
