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organics.synthesia.eu / Pharmacy / Mitoxantrone hydrochloride

Mitoxantrone hydrochloride

The production of the active pharmaceutical substance Mitoxantrone hydrochloride at Synthesia has more than 20 years of tradition. Mitoxantrone is further used for the manufacture of dosage form which is used in treatment of patients, especially those who have been diagnosed with cancer. Despite the fast development in the treatment of cancer, Mitoxantrone maintains its position amongst the drugs in the treatment of certain types of cancer.

This drug belongs to the group known as cytotoxic or antineoplastic.

We offer high quality product - USP, PhEur, production under strict GMP conditions, full registration support (DMF), prompt deliveries and customer service.

 

 
Trade Name:   Mitoxantrone hydrochloride
Chemical Name:   1,4-Dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]-9,10-anthracenedione dihydrochloride
CAS:   70476-82-3
EINECS:   274-619-1
Synonyms:   1,4-Dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthraquinone dihydrochloride
Chemical Formula:  

C22H28N4O6 . 2 ClH

Structural Formula:   Mitoxantrone hydrochloride
Molecular Weight:   517.40
Characteristics:  

dark blue, hygroscopic crystalline powder, odourless

 

 

Quality values

The product complies with the prescriptions:   USP   Ph.Eur.
Characteristic   -   dark blue powder
Solubility   -   water-soluble, methanol-mildly soluble, acetone-insoluble
Identification   IR spectrum   IR spectrum
Identification B   -   positive chloride test
Content of active substance in dry substance   97.0 - 102.0 %   97.0 - 102.0 %
Chromatographic purity (HPLC):        
- Sum of all individual impurities:   max. 2.0 %   max. 2.0 %
- Individual unknow single impurity   max. 0.10 %   max. 0.10 %
- Individual know single impurity:        
--impurity A--impurity B--impurity C--impurity D   max. 1 % - max. 1 % - max. 1 % - max. 1 %   max. 1 % - max. 1 % - max. 1 % - max. 1 %
Water - content (K. Fischer)   max. 6.0 %   max. 6.0 %
Alcohol content (ethanol)   max. 1.5 %   max. 1.6 %
Heavy metals   max. 0.002 %   max. 0.002 %
Bacterial endotoxines   < 5.0 IU/mg   < 5.0 IU/mg
Residual solvents and organic volatile impurities (GC):        
- aceton- 2-ethoxyethanol- tetrahydrofuran   max. 0.1 % - max. 0.1 % - max. 160 ppm - max. 720 ppm   max. 0.1 % - max. 0.1 % - max. 160 ppm - max. 720 ppm
Other impurities (HPLC):        
- LMTX- THA- ATHA- ELR- LTHA   max. 0.10 % - max. 0.10 % - max. 0.10 % - max. 0.10 % - max. 0.10 %   max. 0.10 % - max. 0.10 % - max. 0.10 % - max. 0.10 % - max. 0.10 %

 

Packaging

fotografie balení vitamínu D2

Brown glass bottle 25 g Packing size: 100 g (4 bottles in a tin)

 

Storage

To be stored at room temperature, in original, tightly closed dark glasses provided with external threaded closures, protected against light, heat, moisture and frost. It has shelf life of two years, provided the specified storage conditions have been observed.

 

Detailed product information can also be saved in PDF format    PDF
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