Sodium Stearyl Fumarate (SSF) is an inert, less hydrophobic alternative to magnesium stearate as a pharmaceutical tablet lubricant.
Molecule Structure
CAS# | 4070-80-8 |
EINECS # | 223-781-1 |
Features & Benefits
■ Improved drug stability.
■ Shorter disintegration times.
■ Faster dissolution rates.
■ Enhanced lubrication efficiency.
■ Harder tablets in comparison to tablets produced with magnesium stearat.
■ Faster formulation development and scale-up
Storage & Handling
Store in original, well-closed container protected from excessive heat and moisture.
Incompatible with chlorhexidine acetate.
Packing: 1kg Aluminum bag/ 5kg drum/ 20kg drum
Regulatory
DMF,CEP,GMP
Safety
Safety Data Sheet has been compiled for Sodium Stearyl Fumarate (SSF) that contains up-to-date information on questions relevant to safety.
■ As lubricants for tablets and capsules with a concentration of 0.5% ~ 3.0% (w/w). Typicals API as below:
Levofloxacin | Metformin hydrochloride | Trandolapril |
Ramipril | Ibuprofen | Metaxalone |
Oseltamivir phosphate | Morapiravir Aildenafil citrate | Sitagliptin phosphate |
Fexofenadine | Diclpfenac | Fluvoxamine maleate |
Isosorbidmononitrate | Roxithromycin | Zopidem |
Zopidem | Vitamin B12 |
■ It can form a protective coat film in effervescent tablets.
■ As this product has one fatty chain less and one hydrophilic group more compared with magnesium stearate, so it can solve the slow dissolution issue of magnesium stearate as lubricant.
■ Suitable for lubricants of razole drugs, which are easy to react with magnesium stearate and cannot use magnesium stearate as lubricant.
■ As a regulator and stabilizer, such as baked foods, floured thickened foods, baked potatoes and processed grains, with dosage for 0.2 %~ 1.0% of the food weight.
Pyhsical Properties
Standard | CP2020/ USP2023/EP11.0 |
White to off-white powder or granule. | |
Less hydrophobic than magnesium stearate | |
Anti-adherent properties | |
Well defined specific surface area | |
High melting point | 224-245 ℃ |
Controlled particle size | D10: 5um max |
D50:8-16um | |
D90: 30um max |