Oleic Acid/Sodium Oleate BP EP USP Pharma Grade: Description and Insights

What is Oleic Acid/Sodium Oleate BP EP USP Pharma Grade?

Oleic Acid, with the formula C₁₈H₃₄O₂, holds a steady place among fatty acids, showing up in both natural oils and pharmaceutical ingredients. Sodium Oleate, its sodium salt, comes together when sodium hydroxide reacts with pure oleic acid. Each compound traces back to animal fats or vegetable oil sources, blending chemistry with nature. Oleic Acid/Sodium Oleate BP EP USP Pharma Grade stands as a purified, regulated form, shaped to align with strict pharmacopeial benchmarks. These benchmarks—BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia)—help protect consistency, quality, and patient safety. Across medicine and industry, these grade labels set apart substances that meet high standards for traceability and formulation.

Chemical Structure and Properties

Chemically, Oleic Acid carries a cis-double bond at the ninth carbon—the “omega-9” position—within a straight-chain structure, which brings flexibility around melting and solubility. Sodium Oleate follows suit, sharing the same backbone but packed as its sodium salt. This salt form shifts the compound from oily liquid to a solid with better water solubility. Both substances usually come as clear to pale yellow liquids or waxy solids at room temperature, but conversion into powder, flakes, pearls, or solution happens on demand during processing. The molecular weight clocks in near 282.47 g/mol for Oleic Acid and 304.44 g/mol for Sodium Oleate. Melting points hover between 13 °C (Oleic Acid) and 232 °C (Sodium Oleate). Density varies, with Oleic Acid around 0.89 g/cm³ as a liquid. In crystal or pearl form, Sodium Oleate turns slightly less dense but easily handled.

Specifications, Raw Materials, and Physical Forms

Manufacturers start with vegetable oils, often sunflower or canola, using saponification and fractional distillation to pull out pure Oleic Acid. Sodium Oleate arises from Oleic Acid plus sodium hydroxide, resulting in a pale solid. Quality checks at each step filter out heavy metals, peroxides, and contaminants. Buyers look for compliance with BP, EP, or USP standards on purity, acid value, iodine value, and moisture levels, where water content stays low under 2%. Bulk shipments include a range of forms—dense flakes, fine powders, solid blocks, clear liquids, or concentrated aqueous solutions per liter—favored by industrial and pharmaceutical labs. Every lot includes details on batch date, specification norms, and even a certificate of analysis.

HS Code and Regulatory Compliance

For trade and regulatory purposes, the HS (Harmonized System) code for Oleic Acid falls under 3823.13 for industrial fatty acids, with Sodium Oleate classified under 3402.11 for organic surface-active agents. This helps streamline import/export between regions while signaling the substance’s intended industrial or medical use. Good documentation matters—regulatory agencies and customs ask for clear identification, proper labeling, and full lists of chemical properties before approving finished or raw materials for crossing borders.

Applications, Hazards, and Handling

Both Oleic Acid and Sodium Oleate land in a broad mix of uses ranging from skin creams, ointments, tablet manufacturing, to laboratory reagents. Their surfactant and emulsifying roles bring stability to diverse mixtures, supporting wound-healing kits and inhalable therapies. As with all raw chemicals, proper training and storage minimize risk. Oleic Acid shows low toxicity in pure form, but large-scale exposure—like in concentrated vapor from industrial plants—may irritate skin or eyes. Sodium Oleate, though mild for most users, may burn or corrode tissue in direct undiluted contact. Both chemicals need safe packaging—often HDPE drums, polymer bags, or lined barrels. Handlers wear gloves and goggles to stay clear of splash hazards. Spills get neutralized with sand or non-combustible absorbents, avoiding direct drain disposal due to waterway concerns. Workplaces watch for proper ventilation, labeling, and training on the Material Safety Data Sheet, which maps out spill response, storage needs, and first aid advice.

Quality Control, Safety, and Potential Solutions

Pharma grade Oleic Acid/Sodium Oleate demands strict quality control, where impurities—even in single-digit ppm—can compromise a medicine’s safety or shelf life. Regular audits, batch tracing, and rigorous screening for heavy metals, chlorinated byproducts, or microbial growth defend the reliability of supply. Any charging toward green chemistry could reduce harmful solvent use in production, while closed-loop distillation helps recycle raw materials. New analytical standards, like chiral chromatography or rapid in-line IR, push detection of even faint contaminants. Communication on hazards helps manufacturers and end-users. Clear, fact-checked safety sheets let users take charge of chemical hazards, resisting vague language or incomplete guidance.