85504-84-3Relevant articles and documents
Stable and safe idarubicin pharmaceutical composition and preparation method thereof
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Paragraph 0038; 0039, (2018/03/26)
The invention discloses a stable and safe idarubicin pharmaceutical composition and a preparation method thereof. The pharmaceutical composition contains idarubicin or a pharmaceutically acceptable salt thereof and a compound of formula A or a pharmaceutically acceptable salt thereof in an amount of no more than 0.3%. According to the method, an impurity A in idarubicin is separated and confirmed.Prior to this, there is no report that the impurity A is present in the idarubicin. The impurity A is fully researched, it is found that the existence of the impurity A affects the physical and chemical stability of idarubicin and increases cardiac toxicity of idarubicin. The pharmaceutical composition enables idarubicin to maintain good stability. The invention further provides a method for preparing the impurity A. The high-purity impurity A can be acquired to serve as a reference sample or a standard sample for controlling the content of the impurity A in idarubicin and preparations thereof.