Daunorubicin hydrochloride

Daunorubicin hydrochloride
Synonyms:WP900 HYDROCHLORIDE;daunoblastin;daunoblastina;daunomycinchlorohydrate;ndc0082-4155;ondena;rp13057hydrochloride;rubidomycinhydrochloride
CAS:23541-50-6
MF:C27H30ClNO10
MW:563.98
EINECS:245-723-4
General Description:Orange-red powder. Thin red needles decomposing at 188-190°C. An anti-cancer drug.
Air & Water Reactions:Water soluble.
Reactivity Profile:Daunorubicin hydrochloride may emit toxic oxides of nitrogen when heated.
Biological Activity:Anticancer agent that is clinically used to treat nonlymphocytic leukaemia. Inhibits RNA and DNA synthesis and causes DNA fragmentation in vivo .
Usage:A DNA intercalator which may suppress acute leukemia proliferation.

TESTSPECIFICATIONRESULT
AppearanceOrange-red or red crystalline powder; No visible evidence of contamination by foreign matter.Conforms
SolubilityLightly soluble in water and methanol; slightly soluble in ethanol (95%); practically insoluble in chloroform or acetone.Conforms
Identification AIR spectrum corresponds to the IR spectrum of the reference standardConforms
Identification BThe retention time of the main peak obtain with the assay preparation corresponds to that obtained with the standard preparation as directed in the assayConforms
pH4.0 to 5.55.1
Water ContentNot More Than 3.0%1.5%

Related Substances
Any Other ImpurityNot More Than 1.5%0.86%
Total ImpuritiesNot More Than 3.0% 1.6%
Assay842ug to 1030ug of C27H29NO10 calculated on the anhydrous, solvent-free basis925ug
Residual Solvents
Methanol + EthanolNot More Than 0.2%0.12%
Butyl alcoholNot More Than 1.0%0.60%
AcetoneNot More Than 0.5%0.3%
ChloroformNot More Than 0.6%Conforms
ConclusionTo be complied with USP 34 specifications

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