Sodium Stearyl Fumarate (SSF) Pharmaceutical Lubricant | High API Compatibility, Alternative to Magnesium Stearate, GMP Grade

Our Sodium Stearyl Fumarate (SSF) is a high-purity pharmaceutical lubricant specifically designed for tablet and capsule formulations. Unlike magnesium stearate, it offers excellent API compatibility, robustness to over-lubrication, and no adverse effect on bioavailability. It is a hydrophilic, semi-soluble lubricant that provides superior tablet hardness at equivalent compression forces and minimizes impact on disintegration time. Conforms to USP-NF, EP, and JP pharmacopoeias with CDE registration (F20190000009) and DMF support (38822). Recommended usage level: 0.5-3% w/w. Ideal for high-speed direct compression, effervescent tablets, and formulations with incompatible APIs

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Product Detail

Pharmaceutical Grade Sodium Stearyl Fumarate (SSF)

Product Overview

Sodium Stearyl Fumarate (SSF) is a high-performance pharmaceutical lubricant widely recognized as a superior alternative to traditional lubricants such as magnesium stearate and talc. It is a sodium salt of stearyl fumaric acid, appearing as a white to off-white fine powder with amphiphilic properties that enable effective boundary lubrication in tablet and capsule formulations.

Product Identity:

Chemical Name: Sodium Stearyl Fumarate
CAS Number: 4070-80-8
CDE Registration No.: F20190000009
DMF No.: 38822
Pharmacopoeia Compliance: USP-NF, EP, JP
Molecular Formula: C22H39NaO4
Molecular Weight: 390.53 g/mol

Key Features & Benefits

1. Superior API Compatibility

Solves compatibility issues frequently encountered with magnesium stearate
Reported API incompatibilities with magnesium stearate include: Azathioprine, Cefaclor, Cilazapril, Clopidogrel, Diclofenac, Ibuprofen, Omeprazole, and many others
Ideal for formulations where chemical incompatibility is a concern

2. Robustness to Over-Lubrication

Unlike magnesium stearate, SSF maintains performance even with extended mixing times
Provides consistent tablet hardness and disintegration without "over-lubrication" effects

3. Enhanced Tablet Properties

Superior hardness at equivalent compression forces compared to other lubricants
Less impact on disintegration time – maintains fast tablet breakdown
No adverse effect on bioavailability – ensures drug release profiles remain intact

4. Hydrophilic & Semi-Soluble Nature

Water-soluble lubricant – 0.5 mg/100 mL at 25°C, increasing to 20 g/100 mL at 90°C
Results in low residue in solution, making it ideal for effervescent tablets
Improves dissolution profiles of poorly soluble APIs

5. Excellent Physical Properties