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Sodium stearyl fumarate is a hydrophilic lubricant used as a lubricant in pharmaceutical excipients. In the field of pharmaceuticals, sodium stearyl fumarate is added to pharmaceutical preparations, which can be used as a lubricant for tablets and capsules, and can also form a protective film in effervescent tablets, which can solve the problems of stearate lubricants, and can improve drug disintegration and promote drug dissolution.
Items | Specifications | Results |
Appearance | White or almost white, fine powder with agglomerates of flat, circular particles. | Almost white powder |
Identification | IR | Conforms |
Solubility | Practically insoluble in water,slightly soluble in methanol,practically insoluble in acetone and in anhydrous ethanol | Conforms |
Water | ≤5.0% | 2.8% |
Lead | ≤10ppm | ＜10ppm |
Saponification value (anhydrous basis) | 142.2-146.0 | 144.3 |
Limit of sodium stearyl maleate and stearyl alcohol(USP ，by TLC) | ||
sodium stearyl maleate | ≤0.25% | Conforms |
stearyl alcohol | ≤0.5% | Conforms |
Related substances(GC,EP) | ||
sodium stearyl maleate | ≤0.25% | 0.09% |
stearyl alcohol | ≤0.5% | 0.19% |
Max single impurity | ≤0.5% | 0.18% |
Total impurities | ≤5.0% | 0.67% |
Residual solvents （QS-E01-03） | ||
Ethanol | ≤5000ppm | 433ppm |
Ethyl acetate | ≤5000ppm | Not detected |
Toluene | ≤890ppm | Not detected |
Assay | 99.0%-101.5% | 100.3% |
Conclusion | The product conforms to the above specifications. | |
| Product parameters | |
| Cas number: | 4070-80-8 |
| Appearance: | White or almost white crystalline powder |
| Purity: | 99~101.5% |
| Package details: | 1kg/foil bag; 25kg/drum |
| Brand: | Fortunachem |
Uses:
| Item | Details |
|---|---|
| Chinese name | 硬脂醇富马酸钠 |
| English / INCI | Sodium Stearyl Fumarate (SSF); sodium octadecyl fumarate |
| CAS | 4070-80-8 |
| Formula / MW | C₂₂H₃₉NaO₄ / ≈390.5 |
| Structure | Sodium salt of the mono-stearyl ester of fumaric acid (C18 alkyl chain + fumarate head) |
| Appearance | White to off-white fine powder or granules |
| Solubility | Practically insoluble in water (forms a dispersion); slightly soluble in hot ethanol/organic solvents |
| Typical particle size | Micronized grades ~5–25 µm (critical for lubrication efficiency) |
| Nature | Anionic, amphiphilic (hydrophilic carboxylate head + long lipophilic tail) |
| Origin | Typically vegetable-derived stearyl alcohol + fumaric acid esterification → neutralization with NaOH/Na₂CO₃ |
| Storage | Sealed, dry, ambient; non-hygroscopic, long shelf life |
| HS code | 2917.19 / 3402 (check locally) |
2. Main uses
① Tablet/capsule lubricant (core use, pharma)
Added at ~0.5–2% (vs. 0.25–1% for Mg stearate) in direct compression, dry/wet granulation and ODT formulations. Because it is hydrophilic, it retards disintegration and dissolution far less than Mg stearate — ideal for poorly soluble drugs, sustained-release matrices, and products where hardness/dissolution balance is tight. Also less sensitive to over-lubrication and over-mixing.
② Avoiding Mg²⁺/stearate incompatibilities
Used where magnesium stearate causes problems: acidic or chelation-prone APIs, Mg-catalyzed degradation, color change, or assay drift; also preferred in sodium-compatible, low-Mg formulations and certain effervescent/buffered systems.
③ Vegetarian/vegan & clean-label positioning
No animal origin (Mg stearate is often beef/pork derived), so it supports vegan/vegetarian, halal/kosher-friendly and "clean label" claims in both pharma and nutraceuticals.
④ Nutraceuticals & food-contact applications
Lubricant/glidant function in tablets, gummies release aid, and process aid where permitted; check local food-regulation status before claiming food use.
⑤ Cosmetics & personal care (INCI: Sodium Stearyl Fumarate)
Anionic emulsifier/co-emulsifier, viscosity modifier and skin-conditioning agent in creams, lotions, sticks and pressed powders; helps stabilize oil-in-water systems and improve spreadability.
⑥ Other industrial uses
Release agent/process aid in polymer & pigment dispersions, surfactant intermediate, and research-grade amphiphile for wetting studies.
3. Selling points
Performance
Hydrophilic lubrication: protects disintegration/dissolution and reduces over-lubrication risk — the single biggest technical reason formulators switch from Mg stearate.
No divalent metal ion: avoids Mg²⁺-driven incompatibility/degradation pathways; useful for sensitive APIs and fixed-dose combinations.
Broad processing window: works in DC and granulation, tolerant of longer blend times, compatible with most common excipients.
Vegetable-derived, animal-free: satisfies vegan/halal/kosher and sourcing-policy requirements out of the box.
Commercial
5. Excipient economics: low dose but recurring, program-long demand; once qualified in a formulation it is rarely changed → sticky business.
6. Grade ladder & documentation: pharma-grade (with excipient dossier/DMF support, TSE/BSE-free, non-GMO, residual solvent, heavy metals, microbial limits, particle-size spec) vs. cosmetic/nutraceutical grade; margin scales with docs.
7. Quality levers you can prove: assay/acid value, free fatty alcohol & free fumaric acid limits, Na content, PSD (D50/D90), moisture, bulk/tapped density, flow index, whiteness, and lot-to-lot consistency of lubrication efficiency (tablet hardness/ejection force data).
8. Cross-sell: pair with Mg stearate, stearic acid, sodium stearyl lactylate, fumaric/succinic acids, colloidal silica, talc, MCC, and the full lipid-excipient portfolio — one inquiry becomes a formulation basket.
9. Easy logistics: ambient, non-hazardous, non-volatile solid, long retest period, low freight cost.
4. Risks worth disclosing
Higher usage level & cost: typically 0.5–2% vs. 0.25–1% for Mg stearate → cost-in-use must be justified; price per kg is higher, so position on performance and qualification savings, not unit price.
Solubility/dispersion: water-insoluble — needs proper blending sequence and adequate shear; poor dispersion causes specks/sticking. Always run blend-uniformity and ejection-force trials.
Not a drop-in everywhere: can slightly raise tablet friability or alter compaction profile; some formulations still prefer Mg stearate or a blend of the two. Recommend side-by-side trials.
Sodium load: negligible in most cases but worth flagging for very low-sodium indications and regulatory labeling reviews.
Regulatory boundaries: pharma excipient use requires appropriate grade + dossier; food use depends on local approvals (do not assume global food status); cosmetic use per INCI filing. RUO/research packs must not carry finished-dosage claims.
Handling: mild irritant dust — standard PPE; keep dry to avoid caking.
Also, if you have any other questions, you can contact us
FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.
Also, if you have any other questions, you can contact us
FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.
Name:Wuhan Fortuna Chemical Co.,Ltd
Category:Others
Trade Category: Trading Company
Employees: 11 - 50 People
Address: Room 2015, No.2 Building, Kaixin Mansion No.107
Company Information: Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Sodium Stearyl Fumarate with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Sodium Stearyl Fumarate.
1. Guaranteed purity;
2. Large quantity in stock;
3. Largest manufacturer;
4. Best service after shipment with email;
5. High quality & competitive price;
Used as cationic transfection agent, bile acid sequestrant, vaccine adjuvant, protein stabilizer.
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