Hot Selling Vinorelbine 71486-22-1in Buk Supply

Test Item

Specifications 

Result

Apperance

White to yellow or light brown, amorphous powder

white powder

Solubility

Freely soluble in water

Complies

Color of solution

The solution is clear

Complies

Identification

A: Infrared absorption

B: RT of main peak

C: Reaction of tartrates

Complies to the reference standard

Complies to the reference standard

Positive

Complies

Complies

Complies

pH

3.3 ~ 3.8

3.4

Residue on ignition

≤0.1%

0.01%

Water

≤4.0%

2.2%

Related Substances

3,6-Epoxy vinorelbine

Vinorelbine Impurity A

Any individual impurity

Total impurities

≤0.3% (3,6-Epoxy vinorelbine)

≤0.2% (Vinorelbine Impurity A)

≤0.2% (Any individual impurity)

≤0.7% (Total impurities)

Not found   

Not found  

0.06%

0.2%

Residual Solvent

Acetone

Methanol

Methylene chloride

Chloroform

Tetrahydrofuran

Ethanol

≤0.5%

≤0.3%

≤0.006%

≤0.072%

≤0.5%

≤0.5%

0.354%

0.045%

0.0004%

Not found

Not found

0.037%

Microbial Limit

Bacteria

Fungi

Escherichia coli

≤800cfu/g

≤80cfu/g

Not Found/g

20cfu/g

20cfu/g

Not Found/g

Assay 

98.0%~102.0%

99.8%