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Calcium stearate stands as a white, waxy solid made through the reaction of stearic acid with calcium oxide or calcium hydroxide. The substance shows up in pharmaceutical work under strict BP, EP, and USP standards, which refer to British, European, and United States Pharmacopeias. As someone familiar with pharmaceutical manufacturing, I notice how these grades matter for quality, purity, and the safety of finished medicines. This grade of calcium stearate often comes in several forms, including fine powder, compacted flakes, granules, and sometimes as dense pearls depending on production methods. The physical feel remains typically mild, showing a soapy finish to the touch, which often helps in blending and handling processes during medicine production.
At its core, calcium stearate’s molecular formula is C36H70CaO4 with a molar mass near 607.02 g/mol. This means the compound builds on two stearic acid units attached to a single calcium ion. Properties in powder form make the substance nearly insoluble in water, providing excellent anti-caking and lubricating benefits in pharmaceutical tablets. Density ranges close to 1.08 g/cm3, giving some heft but not the bulkiness seen in heavier compounds. Melting points hit around 160°C—something I’ve seen prevent clumping in product blending rooms. As I’ve worked with lab techs, they often appreciate that calcium stearate remains chemically inert, not reacting with most tablet excipients. The crystalline nature under the microscope shows long, needlelike structures when crystallized from the melt, which gives hints to its lubrication powers in solid mixes.
Product specifications always demand attention in high-quality pharmaceutical production. Most BP EP USP certified calcium stearate lists low heavy metal content—usually less than 10 parts per million, keeping toxicity risks extremely low. Official Clarity and Color tests prove the product won’t add unwanted hues or turbidity during dissolution. Moisture content lands under 4%, keeping the powder from caking or misbehaving in fluid bed granulators. The bulk material, whether flakes or powder, handles well in silos and hopper feeds without bridging or sticking, a fact I’ve watched production engineers confirm in scale-up trials. Specific surface area numbers tend to fall between 1.5 and 4 m2/g; more open surface means more effective performance as a lubricant or flow agent in tablets or capsules.
Any facility handling international trade and import sees calcium stearate labeled with the HS Code 29157050 for customs and compliance work. This code governs oversight and record-keeping for excipients entering pharmaceutical production in all major markets. Pharmacopoeial certification ties into regulatory review because authorities like FDA or EMA check the documentation for BP, EP, or USP marks. In some of my work alongside quality assurance teams, auditors dive into material traceability and batch records, and discrepancies with the recognized pharmacopoeial standard stall product release. By sticking with approved, trackable sources, companies prevent compliance headaches and keep their finished drug formulations moving along.
The low water solubility of calcium stearate comes from its long hydrocarbon chains, which also reduce static and flow issues when compressed into a tablet die. That means operators can avoid sticky blends and wasted runs. I’ve noticed the compound doesn’t dissolve well in cold solvent; it disperses slightly in hot oils or in some aromatic hydrocarbons, but water-based dissolution won’t yield much. Calcium stearate in liquid suspensions creates stable emulsions thanks to its fatty acid tails; this matters for liquid syrups and nutritional pills. In solid dosage manufacturing, the fine particle size allows smooth integration with other powdered actives. Most often, processors blend it near the end of the batch to prevent loss of lubricity, and dosing is strictly limited—too much risks softening tablets. The consistent molecular weight and composition per specification mean labs don’t have to keep checking batch-to-batch reactivity: QA releases batches faster, and the end result keeps meeting dissolution and friability specs.
Manufacturers offer calcium stearate in several distinct forms for pharma and nutraceutical use. The powder form tends to look bright white, powdery, with a slippery—or waxy—feel. Flakes appear as semi-translucent chips used when bulk flow and minimal dust generation matter. Pearls, or small round beads, catch the eye in automated dosing systems because they pour neatly and reduce airborne particles. Some specialty producers can also deliver micronized versions, which cut dust even further while enhancing blending with sensitive actives. Each form brings its own benefits—my own experience in tablet plants suggests powder remains the default, as it integrates quickest and doesn’t challenge blending equipment. Liquid solutions and dispersions show up far less in solid dose, but in some food supplement factories, you’ll see dairy-calcium products adding liquid dispersions of calcium stearate straight into milks or yogurts, blending well without separation or clumping.
Both the source of calcium and stearic acid affect final purity. Vegetable-based stearic acid dominates the market now, serving plant-based or halal product needs. Processors avoid animal tallow sources to sidestep BSE, religious, or allergen concerns, and in my quality system reviews for clients, plant origin documentation closes audits without trouble. Trace elements—lead, arsenic, mercury—fall under strict controls, and every batch gets tested by third-party labs for compliance. The water used in processing must meet distilled water or higher purity guidelines, so microbial or endotoxin contamination never occurs. The technical challenge for suppliers comes in maintaining consistent melting point, color, and odor from batch to batch. Given the rising regulatory pressure to prove ‘pharmaceutical grade’ status, I see more companies adopting full validation of supply chains, in-process monitoring, and digital record keeping.
Safety really matters in drug manufacture, both in the plant and for the end user. Calcium stearate BP EP USP pharma grade is regarded as safe, supported by long-standing use in oral medicines and food supplements. Toxicology studies show no genotoxicity, mutagenicity, or reproductive risks at approved use levels. I remember a pharmacopoeia monograph update that restated its GRAS (Generally Recognized as Safe) status in the United States. The product avoids classification as a hazardous material under GHS and US OSHA standards, yet it’s also not devoid of any risk. Fine dusts can irritate sensitive lungs during factory bag dumping; thus, operators work with extraction hoods, N95 masks, and gloves. No strong odors or skin-sensitizing reactions turn up in decades of market use, though sensitive people should avoid direct skin contact for long periods. My time in factory environments showed that keeping the material tightly contained in sealed bags or Bins reduces dust and makes for cleaner operations. Any accidental spill wipes away easily with proper industrial vacuums—no need for special chemical neutralizers.
Calcium stearate plays a quiet but critical role in many medicines—not as an active, but as a tool for reliable, repeatable manufacturing. Every step toward better raw material traceability and supplier quality tightens assurance of safe, high-purity pharma grade. The increasing attention on sustainable and plant-based sourcing reflects consumer and regulatory trends. In the future, I see more companies shifting to small-batch, high-visibility supply chains with real-time batch release, keeping risk low and compliance tight. Ongoing improvements in powder handling and dust control will further cut workplace risks, while advances in analytical methods make sure every dose stays within safe, consistent limits. Calcium stearate may look simple, but every detail—from chemistry to procurement to plant safety—shows just how much goes into a modern pharmaceutical ingredient.
Chengguan District, Lanzhou, Gansu, China
