| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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Specification
| Item | Specification | Result | |
|
Appearance |
white to off white powder |
Complies |
|
|
Related substance (HPLC) |
Total impurity ≤0.5% Max single impurity ≤0.1% |
0.2% 0.06% |
|
|
Odor |
Characteristic |
Complies |
|
|
Assay |
99% |
99.22% |
|
|
Sieve analysis |
100% pass 80 mesh |
Complies |
|
|
Heavy Metal |
<10ppm |
Complies |
|
|
As |
<0.1ppm |
0.05ppm |
|
|
Pb |
<0.1ppm |
0.05ppm |
|
|
Cd |
<0.1ppm |
0.05ppm |
|
|
Residual Solvents |
<100ppm |
Complies |
|
|
Residual Pesticide |
Negative |
Complies |
|
|
Total Plate Count |
<1000cfu/g |
Complies |
|
|
Yeast & Mold |
<100cfu/g |
Complies |
|
|
E.Coli |
Negative |
Complies |
|
|
Salmonella |
Negative |
Complies |
|
Sodium stearyl fumarate is a special water-soluble lubricant for tableting. 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.
Strenghths of Our Products:
1) Living with chemical innovation;
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4) Highly pure and salfe and can be applied in various fields.
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