Name of product

 Sodium Stearyl Fumarate   (SSF)

Batch No.

20111211

Manufacture date

2011/12/11

Expiry date

2013/12/10

Test standard

USP31/NF26/EP5

Test Items

Standard

Result

Description

white or almost white powder

Conforms

Identification

IR

Conforms

Water(K.F.)

≤5.0%

3.5%

Lead

≤0.001%

Conforms

Heavy metals

≤20ppm

＜20ppm

 Saponification value

(anhydrous dasis)

142.2-146.0

143.6

Limit of sodium stearyl maleate and stearyl alcohol

sodium stearyl maleate

≤0.25%

0.1%

Stearyl alcohol

≤0.5%

0.4%

Related substances(by GC)

Any impurity

≤0.5%

0.1%

Total impurities

≤5.0%

1.2%

Organic volatile impurities

Meets the requirement

Conforms

Residual solvents

Meets the requirement

Conforms

Assay

99.0%-101.5%

100.5%

Conclusion

The results conform with USP31/NF26/EP5 standard