Product name

Mitoxantrone Hydrochloride

Quantity

5KG

CAS：

70476-82-3

Batch No.

221226

Report Date

2022.12.26

Manufacture Date

2022.12.26

Expiry Date

2024.12.25

REF .STANDARD

USP40  

Subjects 

 Specifications  

Results

Characters

A dark blue powder

 Conforms

Solubility:

sparingly soluble water；slightly soluble in methanol practically insoluble in acetone              

Conforms

Identification

A: IR

The same to check sample

Conforms

B: UV

λmax242nm,275nm  609nm,663nm

Conforms

C: Colour reactions

Meet the requirement

Conforms

D:Chloride Reactions

positive   

Conforms

Appearance of solution

clearly and colourless  

Conforms

Alcohol

≤1.5%  

Conforms

Acidity(PH)

3.0-5.0  

4.3

Loss on drying

≤6.0%

3.0%

Sulfated ash  

≤0.2%   

0.06%

heavy metal  

NMT10ppm   

Conforms

Related substances(HPLC)

Any single impurity

≤1.0%

0.28%

Total impurities  

≤2.0%   

1.12%

Assay(HPLC)

97 % ---102%

99.1%  

CONCLUSION:   

THE MATERIAL CONFORM WITH USP40