Sodium Stearyl Fumarate USP

Product Overview

Sodium Stearyl Fumarate (SSF) is a high-performance pharmaceutical excipient primarily used as a lubricant in solid oral dosage forms. It offers excellent lubrication efficiency at low concentrations, minimal impact on tablet hardness and dissolution, and superior compatibility with a wide range of APIs. It is also one of Salius Pharma’s star products.

Product Type: Pharmaceutical Excipient

Chemical Name Sodium Stearyl Fumarate

Chemical Formula C22H39NaO4

CAS Number 4070-80-8

Molecular Weight 390.53 g/mol

Regulatory Compliance USP / NF / EP / BP / JP (as applicable)

Manufacturing Suitability Suitable for oral dosage forms, tablets, capsules, and other pharmaceutical formulations.

Storage Conditions Store in a tightly closed container at room temperature, in a cool, dry, well-ventilated area, away from moisture and direct sunlight.

Certifications GMP, ISO 9001:2015. FSSC 22000 certification applicable for food-grade materials if needed.

Availability On-demand production / Global supply capability

HS Code 2915.70.00 – Saturated dicarboxylic acid salts

Excipient Technical Profile

Appearance White or almost white, fine powder with agglomerates of flat, circular particles

Bulk Density 0.2 – 0.35 g/cm³

Solubility Practically insoluble in water; slightly soluble in methanol

pH 8.3 – 8.8 (5% w/v aqueous solution at 90°C)

Melting Point ~215–225 °C (with decomposition)

Typical Applications

Lubricant for tablets and capsules
Suitable for direct compression and wet granulation
Ideal alternative to magnesium stearate where faster dissolution is required
Compatible with moisture- and shear-sensitive APIs

Key Benefits

Effective lubrication at low use levels

Minimal impact on tablet hardness and dissolution

Excellent batch-to-batch consistency

Suitable for high-speed tableting operations

Safety Info

⚠️ Key Safety Considerations

Generally regarded as safe for pharmaceutical use
Avoid generation and inhalation of dust
Use appropriate PPE during handling
Store in well-closed containers away from heat and moisture

Why Choose Salius Pharma?

GMP-Compliant Quality: Adherence to GMP with stringent QC to ensure consistent, premium-grade excipients.
Regulatory Support: Comprehensive documentation available.
Reliable Supply: Global distribution with safe and timely delivery.
Technical Expertise: Dedicated formulation support and customer service.
Customized Solutions: Flexible packaging and product grades tailored to your needs.

FAQs

Sodium Stearyl Fumarate is primarily used as a lubricant in tablet and capsule formulations. It reduces friction during compression, improves powder flow, and supports consistent tablet quality without significantly affecting dissolution.

Compared to magnesium stearate, Sodium Stearyl Fumarate offers effective lubrication at lower concentrations and has a lesser impact on tablet hardness and drug release, making it suitable for formulations requiring faster dissolution.

Yes. It is well suited for direct compression as well as wet granulation processes and performs reliably in high-speed tableting operations.

Yes. Sodium Stearyl Fumarate is one of the most exported excipients from Salius Pharma, supplied consistently to international pharmaceutical customers with stringent quality and regulatory expectations.

What You Receive with Every Order

At Salius Pharma, we deliver more than just an excipient — we deliver confidence, compliance, and quality. Every shipment is thoughtfully prepared to meet international regulatory standards and your exact specifications.

What’s Included:

✔ Premium Product:

High-purity Sodium Stearyl Fumarate USP
Packaged for maximum stability and protection
Moisture-resistant, tamper-evident sealing

✔ Custom Packaging Options:

Tailored drum sizes, blister packs, or bottle formats
Designed to meet your operational needs and dosage requirements

Place an Order or Request a Quote from Salius Pharma

Looking to source Sodium Stearyl Fumarate USP or other high-quality pharmaceutical products?
We’re here to help.
Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

Get in Touch

Email: export@saliuspharma.com
Call / WhatsApp: +91 84258 80640 / +91 84258 80643
Landline: +91 22 49700 601 / +91 22 44503 148
Corporate Office: 3104–3106, Plan S Business Park, Nerul MIDC Opp. Dr. D.Y. Patil Stadium, Navi Mumbai – 400706, Maharashtra, India

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