Sodium Stearyl Fumarate

Sodium stearyl fumarate is a special water-soluble lubricant for tableting. It provides good lubrication at low use levels. Sodium stearyl fumarate is an inert, hydrophilic, tablet lubricant, designed specifically for use where other conventional lubricants are not suitable. It is especially useful in those situations where the usual lubricating agents fail to provide tablets of adequate stability, hardness, content uniformity, disintegration and dissolution rate. Sodium stearyl fumarate is effective at use levels of 1-3%

Specifications

• Identification (IR) To pass test; Fine white powder

• Assay (C22H39NaO4) 99.0-101.5%

• Limit of sodium stearyl maleate Not more than 0.25%

• Limit of stearyl alcohol Not more than 0.5%

• Lead Not more than 10 ppm

• Heavy metals Not more than 20 ppm

• Water determination Not more than 5.0%

• Fats and fixed oils (Saponification Value) (Anhydrous) 142.2-146.0

• Residual solvents

  • Toluene, Class 2 Less than 890 ppm

  • Chloroform, Class 2 Less than 60 ppm