Ethyl Oleate BP EP USP Pharma Grade: In-Depth Product Overview

What is Ethyl Oleate BP EP USP Pharma Grade?

Ethyl Oleate BP EP USP Pharma Grade stands out as a high-purity ester, forged from the reaction of oleic acid and ethanol. This compound finds its place in pharmaceutical manufacturing and compounding because of its distinct chemical and physical properties. Ethyl Oleate comes as a clear, colorless to pale yellow liquid, often unassuming in appearance but instrumental in many pharmaceutical and industrial applications. Its chemical structure, C20H38O2, delivers a balanced blend of flexibility and compatibility with numerous ingredients. Professionals in labs and manufacturing settings count on Ethyl Oleate as a dependable solvent and vehicle for lipid-soluble drugs, leveraging its smooth texture and reliable safety profile. Those working directly with raw materials in pharmaceutical or chemical operations will recognize the importance of a substance that consistently delivers the same molecular performance batch after batch since variability can ruin a process and damage credibility among regulators, peers, and patients.

Physical Properties and Structure

Ethyl Oleate presents as a liquid at room temperature, characterized by a density near 0.87 g/cm³ at 20°C. It falls into the category of unsaturated fatty acid esters, bearing a single cis double bond within its long hydrocarbon chain. The physical structure allows the liquid form to persist even at a cooler ambient temperature, unlike saturated fats or shorter chain esters, which might solidify or become waxy. This product does not form crystals or flakes and avoids the granular appearance of some raw materials. Pharmacies and labs prefer a fluid that pours and mixes effortlessly without clumps or suspended particles, reducing the risk of contamination or incomplete formulation. From personal experience in the lab, working with ethyl oleate removes the headache of pre-heating or battling inconsistent texture. The material stores in tightly-sealed containers to limit exposure to air and moisture, as these factors can cause the compound to oxidize or degrade.

Specification and Compliance

Meeting BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) standards demonstrates a level of control that matters to manufacturers, wholesalers, and healthcare professionals. Regulatory agencies take these certifications seriously because batch consistency, purity, and traceability provide a shield against accidental patient harm. Ethyl Oleate BP EP USP Pharma Grade typically holds an assay of no less than 98%. Quality checks target color, odor, refractive index, density, and acid value, as out-of-spec values could signal impurity or degradation. The product’s HS Code, essential for customs and international shipment, usually falls under 2916.19 for fatty acid esters. Reliable documentation about origin, processing history, and analysis results supplies the transparency that purchasing managers and auditors want to see, and which I’ve found essential when prepping dossiers for regulatory review.

Molecular Formula and Raw Material Background

The molecular formula, C20H38O2, reflects a backbone formed by the ethyl esterification of a C18 monounsaturated fatty acid (oleic acid) with a two-carbon alcohol. Its structure permits the easy dissolution of many active pharmaceutical ingredients that require a non-aqueous carrier. Since both starting materials—ethanol and oleic acid—are widely available, this chemical enjoys steady supply and competitive pricing. Raw material sourcing strategies favor plant-derived oleic acid for reliability and lower contaminant risk. Trace amounts of contaminants can ruin whole batches or present safety concerns. Manufacturers often invest in supplier qualification programs to monitor and control the purity of incoming feedstock, taking the risk of shortcuts or poorly-controlled sources off the table. In practical terms, this approach has protected both product integrity and consumer reputation more times than I can count during audits and inspections.

Safety, Hazardous Profile, and Handling

Ethyl Oleate’s safety reputation traces to decades of clinical and industrial use, where its low toxicity and mild skin or eye irritation profile have been demonstrated. Standard practice still emphasizes gloves, goggles, and proper ventilation since any material—at scale or over time—can present health risks. Accidental ingestion or injection outside of formulated preparations can present harm due to foreign body reactions, so lab managers train staff against such hazards as a matter of routine. The compound is not considered highly flammable nor explosive, but bulk containers should avoid sources of ignition and should remain tightly sealed to avoid hydrolysis and contamination. Waste handling follows local chemical waste guidelines; in my work, documenting proper disposal and accidental spill response is routine and always required by health and safety inspectors. For workers and lab teams, trust in a material grows when manufacturers offer clear, accessible safety data sheets in each shipment, and failure in this area can shut down a procurement pipeline overnight.

Key Applications and Uses in Pharmaceuticals

Pharmaceutical development and formulation call for excipients that combine safety, solubility, and regulatory acceptance. Ethyl Oleate’s solvent properties enable the dissolution of a range of APIs that need a lipid vehicle. Injectable formulations, topical creams, and veterinary products have adopted Ethyl Oleate when water-solubility proves impossible or when stability under varying storage and transport conditions is needed. Its fluid character guarantees that products fill containers at speed, minimizing production downtime owing to clogged pumps or stuck valves. My own experience with small-scale compounding has shown that Ethyl Oleate can deliver sustained-release characteristics that improve drug performance and patient compliance. Manufacturers rely on its well-studied metabolism profile, as it is hydrolyzed by esterases in the body into ethanol and oleic acid—both naturally-occurring molecules, which reduces concerns about toxicity and environmental persistence.

Potential Challenges and Solutions

Risks can center on supply chain integrity and adulteration, as global production and distribution networks grow more complex. Maintaining pharmaceutical grade status isn’t automatic, and batch testing must continue at every point of the supply chain. Investment in digital batch tracking and third-party analytical verification can stamp out fraudulent ingredients before they make it into consumer products. Data-sharing between firms and regulatory authorities helps maintain vigilance. Whether working with small compounding labs or larger commercial facilities, the need for continuous training and updated protocols around storage, transport, and handling never fades. Those who get complacent invite accidents and loss. Continuous process improvement, investment in analytical tools, and willingness to challenge suppliers on documentation and quality reports build an environment where both innovation and safety can coexist.