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Aluminum Stearate BP EP USP Pharma Grade stands as a specialty chemical compound, ranking among the solid aluminum soaps often used in many industries under strict regulatory frameworks. In practical terms, this product materializes as an off-white, very fine powder, but options also show up in forms such as flakes, solid masses, or even small pearls based on production trends and requirements. The formula—C54H105AlO6—tells the real story behind its complex composition. This molecule forms when stearic acid meets aluminum salt, a reaction commonly run in strict temperature-controlled vessels. Chemical synthesis produces a dense material, with a specific gravity typically ranging from 0.95 to 1.02 grams per cubic centimeter, and it does not dissolve in water. Its solubility in hot mineral oils and aromatic hydrocarbons makes it both versatile and valuable, especially where texture, viscosity, and water repellency matter. HS Code classification often falls under 29157090, marking it as a key player in international raw material flows.
The physical makeup of Aluminum Stearate tells a clear story about its use. Industrial handlers see it as a soft, solid, white mass in bulk or convenient fine powder in pharma settings. It feels greasy under touch, reflecting the strong fatty acid backbone of the stearate molecule. In terms of structural analysis, aluminum sits at the center coordinated to three stearate ions, connected by ionic and covalent bonds. Infrared spectroscopy confirms the presence of long stearate chains and typical C-H and C=O stretches, while X-ray diffraction exposes a crystal matrix with moderate stability. As a powder, it disperses easily in oily solutions, which makes it a frequent addition to medicinal ointments, cosmetic emulsions, and even as an anti-caking agent in tablets. Because of its low aqueous solubility and high melting point above 155°C, the material behaves predictably under stress, resisting breakdown and preserving integrity in finished pharmaceutical forms.
Anyone working on formulation needs to recognize the subtle but critical chemical properties tied to this substance. With a molecular weight reaching about 877.43 g/mol, Aluminum Stearate carries considerable heft for an excipient. It contains about 11.5% to 13.5% aluminum based on stoichiometry, and the stearate portion brings both hydrophobia and good compatibility with lipids. Its pH in aqueous suspension normally shows up neutral to slightly alkaline, and the fatty acid content lends itself to low reactivity with most actives, reducing the risk of unwanted side reactions in complex pharmaceutical blends. Material testing reveals moisture content kept below 5% for BP, EP, and USP-grade designations, crucial for shelf-life and stability claims. The absence of free stearic acid above 3% is key for passing pharmacopoeial purity standards.
Manufacturers and procurement officers put faith in clear specifications to avoid compliance headaches. Most reliable suppliers cite bulk density, particle size, appearance, free fatty acid levels, and loss on drying right on their certificates of analysis. A trusted pharma-grade batch falls inside strict boundaries: white, odorless, dry-flowing powder with bulk density near 0.2 to 0.3 g/ml, low chloride and sulfate content, and no heavy metals above pharmacopoeial thresholds. Laser diffraction studies show average particle sizes from 5 to 60 microns, depending on intended use in topical or enteric release formulations. Specific surface area and degree of substitution matter for rheology in suspensions and emulsions, so careful process control is non-negotiable. Checking HS Code 29157090 quickens customs work and tariff calculations, reducing delays and financial risk.
The direct value of Aluminum Stearate shines in the thickening, gelling, and stabilizing of ointments and creams. Chemists blend it with oils to give dermatological products the right body, providing non-greasy skin feel and moisture resistance. In some tablet cores, it acts as an anti-caking or glidant, helping powders move smoothly through filling and compaction equipment. I’ve seen it used to create water-resistant barriers in topical wound care, keeping formulations in place and protecting healing skin. Beyond basic pharma, it also finds use in non-aqueous suspensions, lubricants, and even as a structural agent in fireproofing pastes or polishes. Its ability to survive harsh excipient interactions, while adding reliable viscosity and texture, explains its popularity in industrial and pharmaceutical materials management.
No chemical should be taken lightly, and Aluminum Stearate deserves respectful handling. In my own work with excipients, safety protocols emphasize dust control and minimization of inhalation risk, since chronic exposure can lead to mild respiratory irritation. From a regulatory view, the product does not count as acutely toxic or highly hazardous under GHS or REACH standards, but safety data sheets warn of combustible dust hazards where fine powders get airborne. Workers should wear protective masks, gloves, and appropriate lab clothing, especially when dispensing or blending large volumes. Disposal protocols direct users to avoid release into drains or natural waterways, since fatty acid residues can contribute to local pollution loads. As with many excipients, the safest path means solid storage, good housekeeping, and awareness of batch traceability from raw materials through finished dose production.
Securing truly pharma-grade Aluminum Stearate for critical medical or topical use often exposes weak links in the supply chain, especially as suppliers fluctuate quality or documentation. Problems tend to arise when vendors lack full traceability or try to pass off technical-grade material as compliant with BP, EP, or USP norms. I’ve learned the hard way that even minor deviations in purity or particle size spell trouble for FDA or EMA inspection. To overcome these risks, buyers should demand independent laboratory verification on every lot, check for clear batch records, and keep lines of communication open with both QA and regulatory teams. Negotiating with suppliers who practice open disclosure about raw material origin, manufacturing process, and packaging protocols always pays off. Auditing facilities, especially in international settings, helps maintain trust and reduces surprises—a lesson that comes with years of navigating fast-moving pharmaceutical requirements.
Understanding the supply chain starts with recognizing that raw stearic acid’s quality influences every specification further down the line. The stearic acid in play for pharma batches gets sourced from vegetable or animal fats, refined, hydrogenated, and purified to remove color bodies and odors, since even trace contaminants affect the aluminum stearate’s chemical signature. Manufacturers blend and react aluminum hydroxide or aluminum sulfate with this acid under steam and controlled pH—a process that leaves little room for shortcuts if consistency and certification matter. If I’ve seen one thing in excipient management, it’s that investing in qualified, sustainable raw material suppliers almost always translates to fewer recalls, more stable lots, and a reduced headache for downstream process engineers and compliance staff.
Quality, consistency, and safety sit at the core of handling and using Aluminum Stearate in pharmaceutical production. My own experience dealing with regulatory pressures, raw material audits, and process troubleshooting sharpened my view that every batch of Aluminum Stearate tells its own story—reflecting the sum of its raw ingredients, production process, and final testing. Adhering to global standards, shading out risky shortcuts, and respecting the material’s chemical power builds a foundation of trust from supplier to patient. In today’s competitive pharmacy landscape, where documentation, precision, and safety define professional pride as much as market wins, Aluminum Stearate BP EP USP Pharma Grade plays a vital, carefully managed role in the larger story of safe, effective medicines.
Chengguan District, Lanzhou, Gansu, China
