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Cabazitaxel

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