MITOXANTRONE HYDROCHLORIDE, CAS: 70476-82-3

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MITOXANTRONE HYDROCHLORIDE

Name:

1,4-Dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthraquinone dihydrochloride

CAS No:

70476-82-3

EINECS No:

274-619-1

Synonyms:

9,10-Anthracenedione, 1,4-dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]-, dihydrochloride

Chemical Formula:

C ₂ ₂ H ₂ ₈ N ₄ O ₆ . 2 C l H

Molecular Weigh:

517,41

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:
--nečistota B--nečistota C--nečistota D	max.0,15 %max.0,15 %max.0,15 %max.0,15 %	max.0,15 %max.0,15 %max.0,15 %max.0,15 %
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 ppmmax.720 ppm	max.0,1 %max.0,1 %max.160 ppmmax.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 %

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.

RID/ADR:

6.1 / T2 / PG III
UN: 3249

Classification:

Carc. cat. 2
Harmful
Repr.cat.3

Labelling:

Toxic

R 45 May cause cancer
R 20/21/22 Harmful by inhalation, in contact with skin and if swallowed
R 63 Possible risk of harm to the unborn child

S 22 Do not breathe dust
S 36/37 Wear suitable protective clothing and gloves
S 45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
S 53 Avoid exposure - obtain special instructions before use