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Linoleic Acid BP EP USP Pharma Grade represents a high-purity form of linoleic acid, tailored for pharmaceutical and laboratory applications. This raw material supports various industries, particularly those that demand stringent quality measures for health and therapeutic products. Sourced from natural oils such as safflower, sunflower, or soybean, linoleic acid forms a principal building block for formulations targeting both efficacy and safety. Its chemical importance stems from its essential fatty acid structure, recognized for both its physiological relevance and manufacturing versatility.
This molecule belongs to the omega-6 fatty acid family, bearing the formula C18H32O2. With two cis double bonds placed at carbons 9 and 12, linoleic acid features a straight hydrocarbon chain broken by subtle kinks, responsible for its semi-liquid nature at room temperature. The molar mass measures approximately 280.45 g/mol, giving analysts and product formulators a precise basis for calculations. Its CAS number, 60-33-3, offers further traceability for regulatory and sourcing needs.
Linoleic acid typically presents as a clear to pale yellow oily liquid. Under standard laboratory conditions, it behaves as a non-volatile, non-crystalline substance, avoiding flakes, pearls, or powder forms unless derivatized or blended. The density rests near 0.90 g/cm³ at 20°C, contributing to its behavior in media and mixes. Its melting point hovers close to minus 5°C, so it remains fluid in almost all working conditions. The boiling point approaches 230°C under atmospheric pressure, reducing concerns about loss during typical pharmaceutical processing.
Pharmacopeial grades—BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia)—demand rigorous testing and batch certification. Specifications often cover acid value, iodine value, peroxide level, color, saponification index, and heavy metal content. For pharma-grade documentation, lead must remain below 0.1 ppm, ensuring safety for parenteral and oral dosage applications. Residual solvents are tightly controlled, and microbial presence is undesirable, supporting both purity and shelf stability.
The harmonized system (HS) code for linoleic acid, often listed as 2916.19, helps customs and trade entities identify, declare, and tax the substance accurately. Pharmaceutical companies and raw material suppliers use this information to confirm compliance with both local and international trade rules, minimize border delays, and provide traceability across the supply chain.
Handling linoleic acid in bulk requires some care, especially for high-concentration liquid forms. Although naturally occurring and widely used in food, pure linoleic acid can irritate skin or eyes and react with oxidizers. Its safety profile remains strong for pharmaceutical applications, provided exposure limits and personal protective equipment guidelines are respected. Material safety data sheets (MSDS) advise storage away from heat, strong light, and air to prevent oxidative degradation and formation of peroxides, which pose both odor and hazard concerns in sensitive applications.
In pharmaceutical formulations, linoleic acid acts as an excipient, penetration enhancer, or emollient. Its ability to integrate with lipid membranes makes it valuable in both topical and systemic products. Beyond pharma, this raw material appears in the synthesis of vitamin F supplements, cosmetics, nutritional blends, soaps, and even as a model compound for oxidative studies. Biochemists and product formulating scientists value its structure because of its involvement in cell signaling and maintenance of barrier functions in skin and tissue.
Storage containers need tight seals, inert atmospheres such as nitrogen, and cool temperatures to extend shelf life and deter spoilage. Light- and oxygen-sensitive, linoleic acid turns rancid if neglected, impacting both specification compliance and end-use safety. Working with this material leads many labs to favor glass or food-grade stainless steel for containment, discouraging leaching and reaction with container walls. Regular lot testing for peroxide values and acidity offers a practical read on freshness and ongoing suitability for sensitive work.
From a formulation standpoint, linoleic acid often becomes the go-to choice for improving skin permeability and bioavailability in dermal products. In quality control labs, I’ve worked with teams tracking oxidation products and monitoring stability in storage—a practical concern because even small deviations affect end product integrity. Process engineers watch for emission of volatile byproducts, especially in heated glass reactors, underscoring the need for vigilance from receipt of raw material through to finished batch. Companies that prioritize well-documented supply chains and genuine BP/EP/USP certificates rarely face batch failures; transparency and regular monitoring create fewer regulatory and customer service headaches.
Despite its popularity, linoleic acid faces issues tied to sourcing and sustainability. Overharvesting from plant oils stresses both price and environmental resources. Initiatives pushing for certified, non-GMO feedstocks and improved extraction efficiency can offset rising costs. Synthetic biology offers a promising path, producing linoleic acid in controlled fermentation environments, reducing dependence on traditional agriculture and sidestepping pesticide residues. Moving forward, tighter global controls on trade and purity benchmarks will push suppliers toward cleaner, consistently documented production lines, giving pharmaceutical makers more confidence in every batch they handle.
Chengguan District, Lanzhou, Gansu, China
