Details Application Typical properties Resources

Sodium Stearyl Fumarate (TekLeu® SSF)

Sodium Stearyl Fumarate (SSF) is an inert, less hydrophobic alternative to magnesium stearate as a pharmaceutical tablet lubricant.

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Details

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.


Application

■ 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.


Typical properties

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