Vindesinsulfat mit GMP und DMF 59917-39-4 Beste Qualität

Test Item

Specifications 

Result

Apperance

White or white bulk or powder; Odourless, with 

hygroscopicity; easy to change color with light or heat

white powder

Solubility

Freely soluble in water or methanol, practically 

insoluble in ethanol.

Complies

Identification

A:Chemical identification

B:UV

C:Infrared absorption

D:Sulfate

Positive reaction

Peak absorption at 215nm and 270nm

Complies to the reference standard

Corresponding to the test for sulfate

Positive reaction

Complies

Complies

Positive reaction

pH

3.5 ~ 4.5

4.0

Solution clarity and color

Solution should be clear and colorless, if has color,

 shall not be deeper than the yellow No. 1 standard

Complies

Loss on drying

≤10.0%

2.9%

Related Substances

Any individual impurity

Total impurities

≤1.2%

≤3.0%

0.78%

2.2%

Residual Solvent

Methanol

Acetone

Ethanol

DCM

Chloroform

THF

≤3000ppm

≤5000ppm

≤5000ppm

≤600ppm

≤60ppm

≤720ppm

14.1ppm

57.9ppm

<1ppm

6.7ppm

8.5ppm

<1ppm

Residue on ignition

≤0.1%

0.1%

Microbial Limit

Bacteria

Fungi

Escherichia coli

≤500cfu/g

≤50cfu/g

Not Found/g

<20cfu/g

<20cfu/g

Not Found/g

Assay 

95.5%~103.0%

96.1%

Conclusion: Complies with all requirements of CP2010