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Pharmaceutical excipients have deep roots that trace back generations, with each decade bringing subtle shifts in ingredient preferences. Stearic Yamanashitan, more recognized globally as Span 60, came about during the surge of industrial biochemistry in the twentieth century. Cosmetic and pharmaceutical industries grew increasingly strict about safety and consistency, driving chemists to engineer ingredients like Span 60 to bridge functionality and purity. Traditional soaps and creams benefited from simple animal and plant fats; as science advanced, researchers demanded higher standards, prompting development of specific esters for precise results. Some of today’s pharmacopeias, such as the British, European, and US standards, classify Span 60 under their most stringent pharma grades, highlighting the journey from commodity emulsifier to regulated excipient.
Stearic Yamanashitan, or Span 60, serves the world as a non-ionic surfactant and emulsifier, especially in pharmaceutical and cosmetic formulations. In tablets, ointments, and creams, professionals value Span 60 for its ability to stabilize oil-in-water mixtures without relying on animal derivatives. Libraries of textbooks and research papers point out its compatibility with other excipients, granting it a reputation that outlasts most synthetic alternatives. Without Span 60, many creams would split, and active ingredients could separate or lose suspension, causing headaches for pharmacists and patients. In short, the role Span 60 plays goes far beyond just "filling space."
Draw a line between chemistry and practical use, and Span 60 lands right in the middle. It presents as a white to pale yellow waxy solid, with a faint odor that rarely impacts sensitive noses. A melting range from roughly 53–58°C makes it workable in most manufacturing settings. Chemically, Span 60’s backbone is sorbitan and stearic acid—yielding an HLB value near 4.7, ideal for stabilizing water-in-oil systems. Solubility remains low in water, yet it dissolves smoothly in most warm oils and organic solvents. This balance lets Span 60 bind oil droplets together, forming a consistent texture in everything from sterile ointments to luxury lip balms. Shelf life stretches for several years under proper storage, outlasting less stable natural fats.
Pharma-grade Span 60 follows rigorous benchmarks set by the BP, EP, and USP. Manufacturers must monitor heavy metals, microbial limits, and peroxide values. Color can’t stray into deep yellows or browns, and acid value usually holds below 15. Saponification value hovers between 147 and 157, reflecting the consistency manufacturers aim for. Each drum or tub arrives with labeling that details batch number, manufacturing and expiration dates, country of origin, and shipment traceability. This thorough paperwork allows pharmacists and regulators to track quality from lab to end user—no one wants to gamble with untraceable excipients.
Span 60 emerges from the reaction between sorbitol and stearic acid, most often under dehydration and catalytic conditions. Industrial reactors heat purified stearic acid with sorbitol, then drive off excess water in a controlled vacuum environment. The end product gets filtered and, if needed, bleached with activated carbon to minimize discoloration. Each stage demands careful monitoring; impurities or overheated batches can yield off-spec wax unsuitable for human use. Factories that produce pharma-grade Span 60 put every batch through tests before allowing it near equipment intended for medicine.
Span 60 operates as a base for further chemical work. Chemists can modify it by adding polyoxyethylene groups, which transforms Span 60 into polysorbates (like Tween 60), giving it higher water solubility and a bigger HLB number. The original ester bond, a product of old school organic chemistry, remains stable under normal storage but can hydrolyze under acidic or enzymatic conditions. These reactions shape Span 60’s behavior inside creams or biological systems. Selecting between native Span 60 and its derivatives often proves crucial for fine-tuning texture, delivery, and interaction with active drugs.
Span 60 wears many hats in industry circles. Stearic Yamanashitan is one name, though sorbitan monostearate holds favor in pharmacopoeias. Chemists might call it E491 on a label or find it listed as “Sorbitan Stearate” or “Hexadecanoic acid, 1,4-anhydro-, monooctadecanoate, (C12-18),” depending on the application. Trademarked versions exist, some tailored for Europe, others for Asia. The diversity in labels means buyers and users need vigilance; one missed dash or tint in a lot number can separate a cosmetic-grade mix from pharma quality.
Span 60’s track record for safety rests on decades of toxicology studies and regulatory reviews. Ingested or topical doses at pharmaceutical levels rarely produce adverse reactions, except in rare hypersensitivity cases. Handling raw Span 60 in bulk calls for classic PPE—gloves and masks—in case of dust. OSHA guidelines don’t typically classify it as hazardous under normal working conditions, though accidental inhalation or eye exposure causes discomfort. Storage spaces must stay cool and dry; humidity or excess heat turns this waxy solid into sticky goo or separates essential ingredients. Pharma settings further implement documentation, traceability, and equipment cleaning protocols, which keep contamination at bay and boost confidence up and down the supply chain.
Pharmacies and cosmetic labs keep boxes of Span 60 for its knack at emulsifying and stabilizing. Common uses include creams, ointments, transdermal patches, chewable tablets, and even slow-release capsules where its waxy viscosity delays dissolution. In cosmetics, it smooths out lotions, prevents “soaping” where skin creams turn white, and helps fragrances diffuse gradually. The food industry labels it as E491 to stabilize creamy fillings or keep chocolate smooth. Its broad utility means that, even with newer synthetic emulsifiers on the market, Span 60’s legacy formula keeps showing up in pilot studies, patent filings, and household brand labels.
Several university labs still tinker with modifications to Span 60. Research over the past decade focuses on nanoparticle drug carriers, where Span 60 aids in encapsulating hydrophobic drugs for targeted delivery in cancer therapy or anti-inflammatory treatments. Some studies push its melting point or tweak its polarity to craft specialized liposomal structures. The pharma world lives and breathes on these incremental improvements—one slight shift in formulation can multiply a drug’s bioavailability or stability. Academic efforts further push its use in oral insulin, topical antibiotics, even in plant-based vaccines, reflecting a shift toward multifunctional excipients fit for ever-expanding needs.
Toxicologists and regulatory agencies take nothing for granted, and the road to GRAS (generally recognized as safe) status for Span 60 draws from years of rodent and human testing. Chronic exposure studies, published as early as the 1950s, established its low acute toxicity and mild impact on metabolism. Modern studies look for sub-chronic effects, possible interactions with other excipients, and influence on gut microbiota. Considering its widespread use in oral and topical routes, industry keeps a close watch on new findings, knowing that safety perceptions can shift overnight if credible research points to overlooked risks.
Looking ahead, Span 60 seems poised to remain part of pharmaceutical and cosmetic chemistries, even as sustainability, allergen reduction, and precision drug delivery shape new ingredient wishlists. Efforts to source stearic acid from renewable palm or alternative crops respond to pushback from environmental groups. More companies look into “green chemistry” for manufacturing, hoping to cut out solvents or catalysts with problematic residues. Some chemical engineers push the boundaries by designing multifunctional versions that can leverage both classic emulsifying behavior and novel drug-carrying properties. As gene therapies, personalized medicine, and novel biologics push regulatory standards even higher, ingredients like Span 60 face more rigorous scrutiny—but those able to evolve under stricter guidelines will likely outlast passing trends. The real challenge comes in keeping transparency, purity, and adaptability at the forefront so manufacturers, clinicians, and end users can trust what goes into every product.
Pharmacies and labs carry a lineup of specialty ingredients, but few get discussed outside tight professional circles. Span 60, known as Stearic Yamanashitan or sorbitan monostearate, is one of those wallflowers. With its status as BP, EP, and USP grade, this ingredient has been approved to meet tough standards set by official pharmacopeias – not just for show, but to earn its way into complex, high-stakes drug production.
Pharmaceutical companies reach for Span 60 for good reasons. Its chemical structure makes it work as an emulsifier, bringing oil and water together. This helps tablets and granules stay together, preserves product stability, and is critical for making creams and ointments smooth. It’s not just about helping things mix; Span 60’s role carries over to how a drug is absorbed by the body, so those few milligrams can decide if a medicine works or falls flat.
My work in pharmacy compounding has put me face to face with Span 60 more times than I can count. You see it mostly in topical creams and oral suspensions, where its ability to keep active ingredients even and smooth means patients get the dose they’re promised. Without it, creams separate, and pills crumble. Children's pain relief suspensions and some antacids would either be chunky or gritty without this key ingredient holding the mix together.
Span 60 doesn’t stop at prescription drugs. It flows into the making of cosmetics, lotions, and even some food additives. The difference in pharmaceutical grade is purity and safety – you don’t want contaminants in an eye ointment. Spa products and over-the-counter balms claim smooth, moisturizing properties, and Span 60 pulls its weight there, too, keeping oil and water-based ingredients blended and shelf-stable.
Concerns about excipients always matter, especially for people who take medicines daily or have allergies. The pharmaceutical world doesn’t leave these questions open. Span 60 has cleared toxicology reviews for its role and quantity used in medicines. Still, regulations demand proof that each batch stands up to strict quality testing – heavy metals, harmful residues, and microbial contaminants cannot slip by. For folks with extremely sensitive skin or food allergies, checking the inactive ingredients in medications remains crucial.
It’s easy to forget what goes into each tablet or tube, but more patients ask what all those hard-to-pronounce ingredients really do. Doctors and pharmacists bridge this knowledge gap if they stay up to date on excipients like Span 60. Education for patients can start with clear labeling, while manufacturers are responsible for maintaining the highest quality. Industry bodies keep updating standards, and public input increasingly shapes those guidelines.
Taking a look at Span 60’s place in pharmaceuticals, patients and professionals both benefit when transparency and safety keep pace with innovation. Stearic Yamanashitan quietly keeps medicines safe, stable, and effective – and deserves a little time in the spotlight.
Stearic Yamanashitan, mostly known as Span 60, has popped up in all sorts of pharmaceutical products. Its job usually involves keeping oil and water from separating, so you end up with a consistent cream, tablet, or capsule. The name alone sounds like something out of a chemistry lab, but Span 60 isn’t just for chemists – regular folks rub it on their skin or swallow it when they take medicine every day.
Most of what we know about Span 60 comes from years of pharmaceutical research and food safety data. The chemical itself, sorbitan monostearate, appears in ointments, eye drops, and even some foods. Health agencies around the world—like the US FDA and the European Food Safety Authority—list it as generally recognized as safe (GRAS). Researchers have looked for reasons for concern, including allergies, build-up in the body, or damage to organs. So far, lab tests haven’t sounded any real alarms.
I have read safety studies done on Span 60 in both animals and people. They checked for irritation, toxic effects on organs, and long-term problems like cancer risk. Doses much larger than you’d find in a single tablet didn’t cause trouble. Sure, any substance can irritate if you use too much. Even plain water in wild amounts isn’t safe. But at the levels allowed in medicines, the risk looks low.
One piece of this puzzle that can’t be overlooked: not every batch of Span 60 is the same. Pharmaceutical grade means a higher purity than the ones used in candles or plastics. FDA and EU rules require tight control over what goes into drugs, which keeps impurities and contaminants out.
I’ve seen what happens when shortcuts get taken. Sometimes companies buy cheap raw materials, thinking it won’t matter if it’s “just an excipient.” That attitude never ends well. Trusted pharmaceutical suppliers use rigorous testing—like checking for heavy metals, residual solvents, and microbial contamination. Patients, especially those with fragile health, deserve high standards.
Some folks get rashes from topical medicines and lotions. In most cases, perfumed oils or preservatives cause these reactions—not Span 60. Still, people with especially sensitive skin or rare allergies could get a mild irritation, just like with many soaps and lotions. Documented cases are rare, but critical doctors and pharmacists report any suspicious reactions so regulators can track patterns.
Few excipients have hard data showing they are “better” than Span 60 for every case. Lecithin, polysorbates, and other surfactants work in some formulas but may cause problems for others. It’s a balance: chemists must match a material with the type of medicine and how a patient will use it.
Responsible companies keep up with new research and demand full traceability for their ingredients. They do more than just comply with rules on paper—they analyze new batches of excipients, assess patient reports for rare side effects, and share findings with colleagues. Hospitals and pharmacies should also get batches from sources they trust. If something feels off or patients complain, they speak up.
In my years reading up on drug safety, not just the chemical itself but the controls around it matter most. With good sourcing, clear labeling, and open reporting of any problems, Span 60 has earned its place in pharmacies. It’s not free from scrutiny, nor should it be—but as things stand now, proper pharmaceutical-grade Span 60 brings more benefit than risk to the medicines we rely on.
Stearic Yamanashitan, better known by chemists and formulators as Span 60 or sorbitan monostearate, lines shelves in labs and production rooms across pharmaceuticals, cosmetics, and even food manufacturing. Most of these industries don’t gamble with ingredients, especially when the final product enters a human body or sits on top of skin. This is where standards like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) come into play. Each standard acts as an agreed-upon rulebook, keeping the compound’s profile in check and risks low.
Having spent years navigating raw material specs, I’ve met plenty of people baffled by the alphabet soup of quality certifications. If someone puts Span 60 in a cream, a tablet, or a food emulsion, the stakes ride on its reliability — especially its purity, fatty acid makeup, and production controls. Let’s walk through how these specs keep supply chains honest and products safe.
Pureness isn’t a hollow selling point. It means fewer contaminants, reduced side effects, and more consistent results. The BP, EP, and USP each demand sorbitan monostearate hits a minimum purity of 95%—often closer to 97%. Manufacturers wring out glycerides, remove excess stearic acid, and keep the levels of unsaponifiable matter low. Most labs push the snooze button on small details, but those details mean real differences in things like allergic responses or product breakdown. In pharmaceuticals, even a hint of impurities can spell trouble by interfering with active ingredients or messing up dissolution rates.
Pure Span 60 stands out for its physical and chemical consistency. Its acid value shouldn’t climb above 7 (measured as mg KOH/g). That number protects against leftover acid that could irritate skin or crash a formulation. Saponification values drift around 145-160, reflecting a balanced mixture of the stearate molecules needed for emulsifying magic. Water content never exceeds 1.5%. This cuts down on spoilage and clumping during storage. Loss on drying sits below 2%, signaling the absence of extra volatile matter. Melting point consistently lands between 53°C to 57°C. This narrow range matters for manufacturing—anything outside could bungle mixing and dosing. Heavy metals like lead, and arsenic, get hammered down to parts-per-million levels, shielded by strict limits (like lead below 2 ppm, arsenic below 3 ppm in most cases). These toxins add up quietly over time, so a proper test routine holds doors shut for them.
Working with Span 60 under these standards, the difference shows up in batch-to-batch trust. Quality checks help a skin cream avoid gritty residue. A tablet won’t turn brittle halfway through the shelf life. Food manufacturers get more stability, less phase separation, and cleaner tastes. Down the line, pharmacists or consumers see one less worry when grabbing items off the shelf. It turns out, precision matters most for the people furthest from the production lines.
When sourcing Span 60, relying on documented BP, EP, or USP compliance proves the first step. Some suppliers skate by with half-baked paperwork or skip independent verification. Audits or third-party laboratory analysis build another layer of trust—catching those rare but costly mistakes before they get downstream. Open channels between quality control and procurement take the surprise out of the process. In my book, putting people first means treating these dry specifications as real-life safeguards, not just paperwork. When every party, from supplier to end user, understands what those purity and specification numbers mean, the whole chain holds together under pressure.
Stearic Yamanashitan, best known as Span 60, means a lot to folks working with creams, lotions, and processed foods. This material handles emulsifying and stabilizing jobs, something labs, manufacturers, and even home product makers count on. These substances end up everywhere—pharma, food, cosmetics—so how we treat them from the moment they arrive shapes the quality down the line.
Finding the right spot for Span 60 isn’t rocket science. What it really needs is a cool, dry, well-ventilated area. Think about high humidity: moisture invites clumping and can spark chemical shifts. Store Span 60 away from any water source and bulk chemicals, especially acids and bases. Poor storage means you face slow breakdowns in your raw material. That translates to creams separating or foods losing their smooth texture.
Direct sunlight can degrade Span 60 over time. Ultraviolet rays throw off the structure of fatty acids and start chipping away at the stabilizing properties this additive carries. In practice, don’t line up your storage drums near windows. A regular shelving rack in a clean storeroom far from sunlight does the job just fine.
Many shops pack Span 60 in air-tight containers. This stops both moisture and airborne contaminants from sneaking in. If you open a container and plan to use the rest later, seal it back up right away. In my experience, rolling down the bag or fastening the lid tightly can save money and headaches. Cross-contamination has a knack for sneaking up, especially where powders and granules are handled without care.
Safety steps shouldn’t get skipped. Even though Span 60 is often found in foods and lotions, it doesn’t belong on bare hands at work. I always reach for gloves and a mask, especially if I’m scooping powders. It’s not about being overcautious—tiny particles float up easily and you don’t want them breathed in or rubbed into your skin.
Labeling containers clearly cuts down on mix-ups. I can’t count how often I’ve seen people scoop from the wrong bin just because the label faded or fell off. Simple things like using bold marker or printed stickers make life a lot easier.
Ignoring basic storage steps adds up. Heat exposure turns Span 60 clumpy and sometimes sticky, so it pours unevenly or won’t blend right. Mold can grow in damp powder, though it’s rare. You can end up tossing out so much product or risk ruining a whole batch of cream or snack foods. If you’ve ever watched a production line grind to a stop, you know how costly little lapses can get.
Once, a neighbor’s small soap shop almost lost an entire batch because their supply stayed open on a humid day. Small fixes—like transferring leftovers to smaller sealed tubs—kept the rest usable. Preventing spills with scoops and sticking to designated mixing tools at all times makes cleanup easier and guards against cross-contamination.
Careful storage and clear handling steps aren’t about ticking boxes on a checklist. They save money, keep products consistent, and protect anyone who comes near Span 60 in a lab or factory. Sticking to proven habits lets the additive do its job, without risking health or making cleanup a bigger headache than it has to be.
Stearic Yamanashitan, better known as Span 60, plays a defining role in pharmaceutical and cosmetic manufacturing. No surprise there—a simple surfactant like this helps blend water and oil, stabilizes creams, and locks in consistency with every batch. Facts show manufacturers can’t afford to slip on quality standards if they want their product trusted in hospitals or over-the-counter shelves. The British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) set the bar. These standards don’t just ask for basic purity, they map out tests for heavy metals, identity, melting point, acid value, and microbiological quality.
Every time a supplier claims compliance, I know from experience it pays to look past the brochure. BP, EP, and USP guidelines say more than “be pure”—they call for documentation and randomized testing. Take Span 60: If it’s coming from a smaller factory somewhere in Asia, local rules might not even match up to what the US or Europe demands. That raises eyebrows, especially when supply chains stretch around the globe.
People in the lab know one bad ingredient batch can sink a whole production run. Regulators recall products for a reason—impurities do sneak in, and sometimes someone tries to cut corners. I’ve seen pharma companies take a hard hit financially just trying to fix issues from a single out-of-spec component. Real compliance starts with supplier transparency. Quality teams ask for certificates of analysis, batch traceability, and audit reports that link every canister of Span 60 to a standard procedure.
British, European, and US rules do have differences, but for something as simple as Span 60, there’s a clear overlap. USP calls for trays for loss on drying, acid value, and identity checks against reference standards. EP and BP demand the same. If Span 60 contains extra fatty acids or a wrong proportion of sorbitan esters, tests catch it quickly. An audit-ready file, from manufacturer to end user, shows where every lot was made, how it was tested, and which batches met all prescribed criteria.
The big danger kicks in with global sourcing. Not every supplier out there tracks compliance the same way. I’ve had to reject whole consignments of excipient before—a missing lab record here, mixed up batch numbers there. Cutting costs upfront sometimes backfires miserably. Assurance means more than a single certificate of analysis tossed in the box. Good pharma companies commission independent labs to cross-check, and the best keep a routine calendar for supplier audits.
Once, I saw a mid-sized company switch to a non-compliant Span 60 supplier. Their lotion started separating. That led not just to wasted production but to recalls, lost customer trust, and hard questions from regulators. The safer approach stands as third-party certification. When Span 60 comes with full documentation linked to BP, EP, and USP benchmarks—and the paperwork checks out—the risk drops sharply.
Any manufacturer serious about quality checks references against each Pharmacopoeia. They stay alert for new monographs or revised testing protocols. On-site audits, pre-shipment checks, and routine sampling remind everyone that compliance rests on evidence, not assumptions.
With rising pressure on supply reliability and product safety, my own advice is to double-down on supplier vetting and lab analysis. Supply chains stretch across continents now, and everyone involved relies on one another to maintain standards set by authorities like BP, EP, and USP. It’s never just about Span 60 or any other excipient. The whole system runs on proof, not promises.
| Names | |
| Preferred IUPAC name | sorbitan hexadecanoate |
| Other names |
Sorbitan Monostearate Span 60 Sorbitan Stearate Stearic Acid Sorbitan Ester Sorbitan Monoctadecanoate |
| Pronunciation | /ˈstɪərɪk jæmˈænəʃiːtæn spæn sɪksti biː piː iː piː juː ɛs piː ˈfɑːrmə ɡreɪd/ |
| Identifiers | |
| CAS Number | 1338-41-6 |
| 3D model (JSmol) | `C1CCCC(CC1)CCCCCCCCCCCCCCCC(=O)OCCOC(C)C` |
| Beilstein Reference | 1853315 |
| ChEBI | CHEBI:90722 |
| ChEMBL | CHEMBL1539365 |
| ChemSpider | 160352 |
| DrugBank | DB02151 |
| ECHA InfoCard | 03d2782a-e6e4-456b-bd61-e169da4b2bd2 |
| EC Number | 266-930-6 |
| Gmelin Reference | 8940 |
| KEGG | C01530 |
| MeSH | Stearic Acid |
| PubChem CID | 5281 |
| RTECS number | WI4395000 |
| UNII | 4ELV173M9D |
| UN number | Not regulated |
| CompTox Dashboard (EPA) | DTXSID3020806 |
| Properties | |
| Chemical formula | C18H38O2 |
| Molar mass | 297.51 g/mol |
| Appearance | White or almost white, waxy, crystalline powder or flakes. |
| Odor | Odorless |
| Density | 0.97 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | 6.7 |
| Vapor pressure | Negligible |
| Acidity (pKa) | ~16.0 |
| Basicity (pKb) | 7.9 |
| Magnetic susceptibility (χ) | Diamagnetic (-8.0 × 10⁻⁶) |
| Refractive index (nD) | 1.428 – 1.434 |
| Viscosity | 200 mPa.s (25°C, 50% in Water) |
| Dipole moment | 1.4220 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 792 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -900.0 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -11310 kJ/mol |
| Pharmacology | |
| ATC code | A05CA02 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory tract irritation. |
| GHS labelling | GHS05, GHS07 |
| Pictograms | GHS07, GHS08 |
| Signal word | Warning |
| Hazard statements | No hazard statements. |
| Precautionary statements | Keep container tightly closed. Store in a cool, dry place. Avoid contact with eyes, skin, and clothing. Wash thoroughly after handling. Use with adequate ventilation. Do not ingest or inhale. |
| NFPA 704 (fire diamond) | NFPA 704: 1-1-0 |
| Flash point | > 195°C |
| Autoignition temperature | > 400°C |
| LD50 (median dose) | > 31600 mg/kg (Rat, oral) |
| NIOSH | Not Listed |
| PEL (Permissible) | Not established |
| REL (Recommended) | 10 mg/m³ |
| Related compounds | |
| Related compounds |
Stearic acid Sorbitan monostearate Polysorbate 60 Sorbitan tristearate Glyceryl stearate |
Chengguan District, Lanzhou, Gansu, China
