Sodium Stearyl Fumarate
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SSF is an inert, hydrophilic tablet lubricant. It has anti-adherent properties, a high melting point and a controlled particle size. It shows less retardant effect on dissolution rate than magnesium stearate even after extended mixing or blending.
SSF is a lubricant used in capsule or tablet formulations. It has superior performance when compared to magnesium stearate:
• Higher tablet hardness
• Lower ejection forces
• Less impact on disintegration times.
• Less sensitive to blending time.
• Semi-soluble so lower residue when in solution or effervescent.
• Especially effective in ODT Tablets.
• Usage level of 0.25 -3.0% w/w concentration. .
|
Physical State |
Solid Substance |
|
Appearance |
White, fine powder with agglomerates of
flate, circular particles |
|
Particle Size |
Not less than 95% pass through 100 mess |
|
Solubility |
Practically insoluble in water, acetone and
ethanol, slightly soluble in methanol. |
|
Water |
Not more than 5.0% |
|
Lead |
Not more than 0.001%. |
|
Heavy Metals |
Not more than 0.002% w/w |
|
Saponification Value |
Limit: 142.2 to 146.0 on anhydrous basis |
|
Limit of sodium stearyl maleate |
Not more than 0.25% |
|
Limit of stearyl alcohol |
Not more than 0.5% |
|
Assay |
It contains not less than 99.0 per cent and
not more than 101.5 per cent w/w on anhydrous
basis. |
|
Residual solvent |
Not More Than 1500 ppm |
|
|
|
Packing: 5 kg corrugated box with LDPE liner inside, 25 kg plastic drum.
Shelf life: At least four years storage life from mfg. date.
Storage: Protect from damp: store at a temperature not exceeding 30⁰ C.
Application of Sodium Stearyl Fumarate
- SSF is a lubricant with a hydrophilic character. It avoids many problems associated with magnesium stearate including active incompatibility, over lubrication, and film formation in effervescent tablets.
- SSF 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.
- SSF is a special water-soluble lubricant for tableting.
- It is effective at use levels of 1-3%.
- Sodium Stearyl Fumarate is an Effective Tablet Lubricant To Avoid Slippery Situations
- It is an inert, hydrophilic, tablet lubricant, designed specifically for use where other conventional lubricants are not suitable.
- It provides good lubrication at low use levels and is much less likely to cause over lubrication than stearate.
