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Stearic Acid Stearyl Alcohol Ester comes from the reaction between stearic acid and stearyl alcohol, both of which show up in numerous pharmaceutical settings. Known under various compendial grades like BP, EP, and USP, this ester stands out as a white or pale, solid material. It may take forms such as flakes, powder, pearls, or even as pressed blocks. This compound holds value as a lubricating agent or binding ingredient, showing reliability in applications where purity and consistency count. In my work with pharmaceutical formulations, the choice of high-purity raw materials like this ester plays a huge role in the stability and quality of the end product. Companies operating internationally pay attention to compendial grades — BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) — since each norm drives the standards of testing, purity, and trace detection.
The structure of the Stearic Acid Stearyl Alcohol Ester features long-chain hydrocarbon groups, a trait it shares with other fatty acid esters. This molecular structure gives it a delicate balance of hydrophobic and (limited) hydrophilic characteristics, depending on formulation environment. The chemical formula usually falls near C36H72O2, with a molecular weight close to 536.94 g/mol, a detail that matters in pharmaceutics for precise calculation of mass balance and solution preparation. Melting point gravitates around 55°C–60°C, and the density hovers close to 0.85–0.88 g/cm3 at 20°C. This physical character enables the material to flow well when used in processes like tablet compression, or in cosmetics for creating creamy, spreadable products. My own experience in compounding highlights the importance of knowing melting and density — they guide batch processing and equipment settings.
Stearic Acid Stearyl Alcohol Ester often appears as large crystalline flakes, smooth powder, or uniform pearls. These forms share a faint, fatty odor, though no sharp scent. Solid at room temperature, this ester slowly turns semi-fluid above its melting range. Handling the various forms includes straightforward weighing and blending, without the mess or volatility that comes from lower-molecular weight chemicals. Packing often comes in multi-layered paper bags or drums, aimed at protecting the material from moisture, dust, and other contamination. My background in pharmaceutical labs taught me to respect the handling instructions, as humidity or poor seals may agglomerate or degrade the ester's texture. Consistency in the physical state makes a difference during compaction, mixing, and even in high-speed tablet machines.
Products carrying BP, EP, or USP grades go through narrow testing for purity, loss on drying, acid value, saponification value, and heavy metal presence. The acid value sits low, often below 2 mg KOH/g, keeping free acid content minimal to avoid unwanted reactions in active pharmaceutical ingredients. Water content typically stays under 0.5%, because water brings the risk of clumping or promoting hydrolysis. Saponification value ranges from 150–170, a useful number when confirming ester content and repeating identity assays. In earlier projects, I saw how lots with high acid or saponification values caused questions from regulatory reviewers and triggered lot rejections — making lab testing a routine, not an afterthought.
The Harmonized System (HS) Code for Stearic Acid Stearyl Alcohol Ester usually fits in 2915.70, a classification that covers fatty acid esters. This code points to international trade conventions, customs documentation, and regulatory paperwork. For anyone working with import/export, the right HS code steers clear of delays at customs and smooths country-to-country movement. When registering for European pharmacopoeial compliance, the trade team needed the HS code on every bill of lading, along with Certificate of Analysis and grade declarations, since non-compliance could mean border holds or product recalls.
The long aliphatic chains in the Stearic Acid Stearyl Alcohol Ester network explain its near-complete insolubility in water, while solvents like chloroform, hexane, and slightly heated ethanol can dissolve it. These chemical features matter since they determine how well the material disperses in emulsions, suspensions, or suspending bases. In oral tablets, for example, solubility influences lubricant action during tablet ejection and dusting rate. Friends working in cosmetics often favor the ester’s lipophilic character for blending oils and waxes into smooth, stable creams.
On the safety front, Stearic Acid Stearyl Alcohol Ester shows low toxicity and carries little acute risk in pharmaceutical form. Still, standard good manufacturing practices apply. Contact with eyes or prolonged skin exposure may cause mild irritation in hypersensitive individuals. The powder’s fine particles could present a dust explosion hazard in poorly ventilated areas, so dust control and local exhaust are recommended in blending rooms. My own experience handling ton-sized batches underscored the importance of gloves and goggles, not because of severe danger but to maintain GMP and personal comfort. Safety Data Sheets (SDS) cover storage at ambient temperatures in dry, closed containers, away from oxidizing agents — practical steps to lock in quality.
Raw materials for making this ester include high-purity stearic acid, commonly sourced from plant oils or tallow, and stearyl alcohol, derived from catalytic hydrogenation steps of fatty acids or natural fats. The traceability and sustainability of these raw materials impact the final ingredient’s status, especially as the pharmaceutical industry leans toward palm-oil-free, RSPO-certified, or even fully synthetic routes for certain products. I’ve seen client requests specifying origin, certification (like kosher or halal), and non-GMO status, reflecting rising consumer standards and global regulatory demand. Sourcing teams spend more time now cross-checking supply chain documentation, recognizing that reliable, quality-assured raw materials keep both regulators and end-users confident.
Pharma-grade Stearic Acid Stearyl Alcohol Esters shape the structure of tablets, support controlled-release formulations, and fine-tune cosmetic emulsions. Their repeated use in so many products owes much to their gentle profile, consistent melting, and easy handling. Regulatory shifts and end-user scrutiny push suppliers to raise the bar on transparency and compliance. In my years connecting with R&D and scale-up teams, the reliability of excipients and inactive agents like this one often determines the pace of product launches and the frequency of batch failures. The right information about properties, material grades, origins, and handling safeguards not only helps manufacturers but also keeps patients and consumers safer in the long run.
Chengguan District, Lanzhou, Gansu, China
