Certification of Analysis

Product Name

Cabazitaxel

CAS No

183133-96-2

Catalog No

SC-94928

Quantity

100g

Batch No

20160906

Product Date

2016-09-06

Date Of Analysis

2016-09-06

Items Of Analysis

Specification

Results

Appearance

White to off white Crystalline powder

Off white Crystalline powder

Water

≤3.0%

0.29%

Residue on Ignition

≤0.2%

0.03%

Heavy Metals

≤0.002%

Conforms

Bacterial endotoxins

≤0.4 EU/mg USP

0.03 EU/mg

Related Substances

Any impurities

≤0.1%

0.02%

Total impurities

≤1.0%

0.02%

Residual solvents

Dichloromethane

≤0.06%

Not detected

n-Heptane

≤0.5%

0.0182%

Acetone

≤0.5%

0.0516%

Ethanol

≤0.5%

Not detected

Methano

≤0.3%

Not detected

Ethyl acetate

≤0.5%

0.0188%

Tetrahydrofuran

≤0.072%

Not detected

Assay

98%min

100.20%

Remark

Declaration: For laboratory use by technically qualified individual only

Conclusion

It accords with the Enterprise Standard

Analyst: Jack Fu

Check: Anne Zhang

Date: 2016-09-06