| Customization: | Available |
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| Powder: | Yes |
| Customized: | Customized |
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Sodium stearyl fumarate is an inert, hydrophilic, lubricant, useful in situations where other lubricating agents (i.e., magnesium stearate) fail to provide adequate stability, hardness, content uniformity, disintegration and dissolution rate.
Sodium stearyl fumarate is a water-soluble lubricant used in the pharmaceutical industry. Sodium stearyl fumarate is an inert, hydrophilic, tablet lubricant, useful in situations where other lubricating agents (i.e., magnesium stearate) fail to provide adequate stability, hardness, content uniformity, disintegration and dissolution rate.
Sodium Stearyl Fumarate is a special water-soluble lubricant for tabletting. It provides good lubrication at low use levels and is much less likely to cause over lubrication than stearate. 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%.
Sodium Stearyl Fumarate (SSF) is a tablet lubricant for use in ODT tablets, in effervescent formulas, or in formulas where the active incompatible with magnesium stearate. It is an inert, less hydrophobic tablet lubricant than magnesium stearate. Tablets made with SSF exhibit less sensitivity to variations in blending time and lubricant levels and have superior hardness characteristics compared to tablets produced with magnesium stearate.
Compatibility studies comparing SSF to Magnesium Stearate showed that SSF was superior with respect to impact on tablet hardness, ejection forces, friability and disintegration. The compatibility of blends was reduced when using magnesium stearate. Ejection forces and friability were also higher for tablets made using magnesium stearate. The disintegration times were longer for magnesium stearate and varied with level.
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Item |
Standard |
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Structural data confirmation |
1. H-NMR: The data of structure are identical with reference standard |
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2. HPLC-MS: Ensure the molecular weight of main peak and fragment peak are identical with reference standard |
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3. IR:The data of IR are identical with that of reference standard |
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Purity(HPLC) |
≥99.0% |
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Related impurities |
Specific single impurity |
Meets EP/USP/BP standards |
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Non-specific single impurity |
≤0.10% |
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Total Impurities |
≤0.50% |
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Crystal form |
Meets EP/USP/BP standards |
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Loss on drying |
≤1.0% |
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Water |
≤1.0% |
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Inorganic salt |
≤0.1% |
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Heavy metals |
≤10 ppm |
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Assay |
99.0%~101.0%(According to EP/USP/BP standards) |
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Microbiological Analysis |
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Total plate count |
≤1000cfu/g |
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Yeast and Moulds |
≤100cfu/g |
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E. Coli. |
Absent |
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Salmonella |
Absent |
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S.aureus |
Absent |
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