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Monostearic acid, known by its molecular formula C18H36O2, falls under the category of saturated fatty acids. This compound, recognized across the pharmaceutical and industrial sectors for its purity and compliance with pharmacopoeial standards, forms a building block for a wide range of finished products. Its structure features a straight-chain 18-carbon backbone, ending with a carboxylic acid group, lending itself to both hydrophobic and amphiphilic applications. The term “BP EP USP” signals that this acid passes the strict standards detailed in the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia, underscoring its relevance for pharmaceutical formulations demanding high quality, low toxicity, and consistent performance.
The physical characteristics of monostearic acid include a white to off-white color, and its texture may vary between powder, flakes, pearls, solid, and sometimes crystalline forms; this versatility means it adapts to different needs in aggregation and solubility. Its melting point typically hovers around 69–70°C. Chemically, it remains stable under standard conditions, with a density of approximately 0.847 g/cm³ at 20°C. Stearic acid demonstrates modest solubility in water, but dissolves more readily in organic solvents such as ether and alcohol. These material qualities shape how the raw chemical gets deployed in industry: powders grant ease of mixing for tablet production, flakes integrate smoothly in topical creams, and the pearl form can decrease airborne particulate during handling.
On the molecular level, monostearic acid bears a straight, even-chain layout with a polar carboxylic group at one end. It derives from the hydrolysis of fats, either animal or vegetable sourced, followed by purification to reach pharma-grade specifications. It does not present unusual reactivity under normal handling, ranking as non-hazardous and non-harmful for standard industrial use. With a low toxicity profile, manufacturers still ought to keep good chemical hygiene, wearing basic personal protective equipment to avoid irritation from accidental skin or eye contact. The material does not count as flammable and shows limited volatility, supporting a strong safety margin in facilities where bulk quantities may be stored or transported.
Pharmacopoeial monostearic acid follows rigorous impurity limits for heavy metals, moisture, and organoleptic deviations. Key criteria include appearance (white powder/flake/pearl), melting point (68-70°C), acid value (206-211), and iodine value (maximum 4). The HS Code for regulatory and customs purposes is generally 29157090, confirming its category among industrial stearic acids and similar fatty acids. Pharmaceutical-grade lots show negligible peroxide content, minimal sulfuric acid residues, and exclude foreign triglycerides or unsaponifiables at problematic concentrations, ensuring that even hypersensitive applications in injectable or oral drug formulations achieve required levels of safety.
Manufacturers turn to monostearic acid in a broad spectrum of uses. In pharmaceuticals, it acts as a lubricant for tablet pressing and as an emulsifying agent in ointments and suppositories. The food industry employs it under the label E570, often in chocolate and chewing gum, for release and anti-caking properties. Cosmetics producers rely on its consistency and mild profile in creams, lotions, shaving products, and soaps. This distribution poses traceability challenges: Keeping accurate batch records, matching HS Codes consistently on shipping paperwork, and enforcing tight quality assurance checkpoints at every transfer preserves material integrity from source to finished good. These steps help prevent counterfeit or inferior raw acids from slipping into sensitive manufacturing lines, where even minor contamination could have outsized effects on product safety and regulatory clearance.
The saturated structure of monostearic acid grants it a high degree of oxidative stability, an advantage for long shelf life in both pharmaceutical and food settings. Unlike shorter or unsaturated fatty acids, monostearic acid resists rancidity and color change, keeping finished products free of off-odors and visual changes; this matters deeply for personal care goods and ingestibles alike. Its amphiphilic base structure means formulators use it to fine-tune emulsification, foam stability, and dispersion. As product lines widen, demand rises for solid, flake, and pearl forms that meet increasingly strict medical and nutritional labeling laws, underscoring the need for accurate chemistry and continuous monitoring.
Suppliers source crude monostearic acid from the hydrolysis and fractionation of triglycerides found in animal fats and plant oils, most often palm, soy, or tallow. Achieving BP EP USP grade means layers of purification—distillation, deodorization, and bleaching—to chase out residual color, aroma, and trace contaminants. Supply chain efficiency and sustainability have come to the foreground as industries pivot away from palm oil-derived feedstock due to ecological and ethical considerations; certified sustainable or synthetic routes promise a lower environmental impact moving forward. Laboratories invest in advanced chromatography and spectrometry to validate high purity levels, and ongoing research into biobased production methods and green chemistry approaches supports future transitions away from legacy raw material streams.
Warehouses store monostearic acid in cool, dry, well-ventilated areas in order to safeguard its physical stability and prevent agglomeration of powders or caking of flakes. Tanks, drums, or heavy-duty bags keep moisture out and prevent oxidative degradation. Safety information details no acute hazards, but best practice calls for limited inhalation or prolonged skin contact; simple gloves and goggles suffice in most contexts. Packaging must display batch numbers, molecular formula, and clear hazard labeling per local and international regulations. With regulatory scrutiny on chemical supply chains increasing, digital traceability platforms, tamper-proof packaging, and third-party certifications provide assurance for buyers and end-users.
Monostearic acid BP EP USP Pharma Grade remains rooted in essential industries, driven by its well-understood structure, manageable safety profile, and proven performance as an excipient and additive. As science advances and markets call for higher transparency, the drive for better material traceability, new raw material inputs, and environmentally conscious sourcing only grows. Stringent adherence to specification and forward-thinking approach in chemical handling guarantee that this foundational material continues to support innovations in foods, medicines, cosmetics, and beyond.
Chengguan District, Lanzhou, Gansu, China
