hot sell Vindesine sulfate

Items

Specifications

Results

Characters

Appearance

White or almost white substance or powder.

White powder

Solubility

Freely soluble in water or in methanol, practically insoluble in ether.

Conforms

Identification

A.    Chemical reaction

Positive

Positive

B.     UV

The light absorption of a solution of 10μg/ml in water exhibits maxima at 215nm and 270nm.

Conforms

C.     IR

The infrared absorption spectrum of the sample is consistent with the spectrum of the reference standard.

Conforms

D.    Chemical reaction

Corresponding to the test for Sulfate

Positive

Tests

P. H:

3.5~5.5 (1mg/ml water)

4.9

Clarity and color of solution

The solution(5mg/ml,water) is clear and colorless, if it display color, more intensely colored than reference solution Y1.

Clear and colorless

Related substances

Single impurity : Not more than 1.5%

0.84%

Total Impurities : Not more than 3.5%

1.8%

Residual Organic solvents

A. Methylene Chloride: Not more than 600ppm

2ppm

B. Chloroform: Not more than 60 ppm

<1ppm

C. Methanol: Not more than 3000 ppm

6ppm

D. Ethanol: Not more than 5000 ppm

440ppm

E. Acetone: Not more than 5000 ppm

1845ppm

F. Tetrahydrofuran: Not more than 720 ppm

<1ppm

Loss on drying

Not more than 10.0%  

9.3%

Microbial Limit

Total aerobic microbial count: < 100 CFU/g

<10CFU/g

Total combined yeasts and molds count: < 50

CFU/g

<10CFU/g

Es. Coli: Not detected/g

Not detected/g

Assay(HPLC)

95.0%~103.0% (dried substance)

96.2%