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Cetostearyl Alcohol BP EP USP Pharma Grade stands out as a fatty alcohol blend used broadly as a raw material in pharmaceuticals and personal care products. Derived from natural sources such as coconut and palm oils, this fatty alcohol features a mixture typically made up of cetyl alcohol (C16H34O) and stearyl alcohol (C18H38O), both contributing to its performance in multiple applications. As both cetyl and stearyl alcohol have long hydrocarbon chains with a single terminal hydroxyl group, this material imparts emollient, emulsifying, and thickening properties to finished formulations. Manufacturers trust it for consistent texture and stability in topical preparations. Its chemical identity and standards fall in line with leading pharmacopoeias, including BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia), guaranteeing traceability and regulatory acceptance across markets where safety and compliance govern all ingredient selection.
This pharmaceutical grade alcohol usually presents itself in solid flakes, white in color, with a waxy feel. Some suppliers process it into fine powder or small pearls. The product remains solid at room temperature, only liquefying above its melting range. It has a melting point commonly between 49°C and 56°C, well suited for production environments aiming for easy handling. Density hovers around 0.81-0.82 g/cm³ at 20°C. This density proves useful for manufacturers speculating on batch calculations and process control, as settling or mixing require reliable physical data. As a raw material, it boasts low solubility in cold water but dissolves better in warm or hot water and various organic solvents. Pharmaceuticals, creams, lotions, and ointments benefit from its semi-occlusive barrier, supporting moisture retention and stability. Its consistency thickens emulsions and stabilizes unstable formulations — a feature often exploited in dermatological products where sensory feel matters to the end user.
The backbone of cetostearyl alcohol lies in its carbon chain skeleton. The typical product contains a blend of cetyl and stearyl alcohol at varying proportions, prioritized according to pharmacopoeial specification or customer demand. The molecular formula of cetyl alcohol is C16H34O (molar mass 242.44 g/mol) and of stearyl alcohol is C18H38O (molar mass 270.50 g/mol). Together, the mixture raises the melting point and enhances structural firming in ointments, creams, and other pharmaceutical bases. Spectroscopic tests, such as infrared and NMR, identify hydroxyl group peaks and hydrocarbon signatures. Susceptibility to oxidation is low, yet facilities monitor for peroxide values and acid numbers within tight limits. Chemical purity, minimum content (usually not below 95-97%), and residue after ignition speak directly to consumers seeking high reliability and certainty in raw materials. Specifications lay out moisture by Karl Fischer below 0.5%, saponification value between 14 and 22, iodine value not exceeding 0.5, and compliance with pharmacopeial contaminant limits.
Cetostearyl Alcohol often carries the Harmonized System (HS) Code 29051700 across customs and import documentation. Its categorization as a fatty alcohol, not a hazardous material under normal handling conditions, makes shipping and storage relatively straightforward — compared to reactive or highly flammable chemicals common in the supply chain. Still, process engineers and workers remain alert to dust formation, which can cause mechanical irritation to eyes or lungs. Safety data encourages the use of protective gloves, masks, and goggles when working with bulk containers. Spills clean easily, given the product’s solid, non-volatile nature. While its toxicity is low, and cases of harmful exposure are rare, assurance of product safety always aligns with Good Manufacturing Practice (GMP) guidelines, including batch traceability, label integrity, and container hygiene. Regulatory dossiers demonstrate compliance with REACH registration, TSCA, and Asian chemical inventories, reducing the risk of commercial or legal barriers and keeping distribution channels open worldwide.
The material shows versatility as an excipient in various dosage forms. Manufacturers often cite its role as an emollient that promotes a smooth, spreadable texture in medicinal creams and ointments. The alcohol blend works synergistically in emulsions by stabilizing oil and water phases, reducing the urgency of additional surfactants or thickeners. Its nonionic nature makes it compatible with a wide range of actives, allowing for flexible formulation options. On the factory floor, line operators and quality managers praise consistency — each batch pours or scoops with familiar resistance, melts without fuss, and integrates smoothly into mixing tanks. With a keen eye on user safety, product developers run consumer tests for skin compatibility, seeking out signs of irritation or sensitization to rare impurities. In solid dosage forms, cetostearyl alcohol serves as a binder or release modifier, supporting proper tablet disintegration or sustained release, attributes valued by both R&D and patients seeking reliable medicine delivery. Over years of working with this ingredient, chemists and formulators lean on its proven record for non-toxic, hypoallergenic behavior in creams, cleansers, hair conditioners, and pharmaceutical bases, reinforcing its position as a go-to fatty alcohol.
Density for this grade draws attention because it impacts not just the logistics of handling, but also the physical properties in finished goods. Many chemists, myself included, appreciate its role when calculating formulation ratios by mass and volume. A reliable density ensures reproducible dosing and packaging. As a solid, cetostearyl alcohol resists flow at room temperature, explaining its preference for flake, bead, or grated presentations. Melting occurs between 49°C and 56°C, and this thermal range allows process engineers to plan heating and mixing steps without scorching sensitive actives. In solutions, it acts as a stabilizing backbone for a variety of solvent systems. While only slightly soluble in cold water, it dissolves in ethanol, ether, and oils, broadening its application reach to both topical and oral products where specific solubility requirements matter. In the glass-lined mixing vessels where I once worked, heating the alcohol to above 60°C created a clear, uniform solution that hydrated or emulsified depending on the process — a practical lesson in raw material adaptability.
Every warehouse storing cetostearyl alcohol follows local chemical safety codes; fire risk remains low under normal storage but rises if heating gets out of control. While it does not rank among hazardous substances by most global standards, safety audits still call for sturdy containment and marked safety zones, especially while handling 25- or 50-kilo bags. Spilled product can become slippery, so cleanup teams keep sand and absorbent material nearby. Waste streams rarely pose major environmental risks due to the alcohol’s low toxicity, but environmental health officers still ask for full traceability on origins and intended use. If mishandled, any chemical can become harmful — which personal experience in plant management underlines every time we update safety plans or run a training drill. Awareness of batch variability, as dictated by the source oils and refining steps, underlines the importance of supplier relationships and quality commitments over price-driven procurement.
Looking at current challenges in the pharmaceuticals supply chain, price volatility and sustainability of palm or coconut origin put pressure on stable sourcing. More manufacturers now partner with RSPO-certified producers or shift to synthetic routes that maintain the required structure without depleting rainforest stocks. Transparent certification, third-party audits, and fair labor practices should form as much a part of buying decisions as purity and price. On the safety front, increased automation and dust-extraction systems limit exposure risks for line workers in handling and mixing. Regular staff training on chemical incident response becomes a frontline defense against rare mishaps. To further reduce batch-to-batch variability, some companies invest in in-line monitoring and real-time analytics — ensuring the alcohol blend maintains consistency across all specifications, rather than relying on post-production testing alone. Open collaboration between regulatory agencies, suppliers, and users creates a feedback loop that tightens controls and improves trust, ultimately ensuring the continued safe, ethical, and effective use of cetostearyl alcohol in health and hygiene products worldwide.
Chengguan District, Lanzhou, Gansu, China
