Pixantrone Dimaleate API is a synthetic oncology active pharmaceutical ingredient belonging to the aza-anthracenedione class of compounds. It is the dimaleate salt of pixantrone and is chemically related to anthracenedione antineoplastic compounds.
The API is identified as Pixantrone Dimaleate, with CAS Number 144675-97-8, molecular formula C₂₅H₂₇N₅O₁₀, and molecular weight 557.5 g/mol. FDA's Global Substance Registration System identifies the substance as Pixantrone Dimaleate, while PubChem independently reports the same CAS number, molecular formula and molecular weight.
Pixantrone Dimaleate is characterized as a dark blue powder. EMA reports that it is slightly soluble in water and propylene glycol, very slightly soluble in ethanol, and soluble in 0.9% sodium chloride and acetate buffer at pH 5.2. It is achiral, non-hygroscopic, and no polymorphism was observed during the reported characterization.
Pixantrone is an aza-anthracenedione compound developed as an antineoplastic agent. The dimaleate salt contains pixantrone associated with two maleic acid molecules.
The pharmaceutical substance has the following principal characteristics:
Chemical Name:
6,9-Bis[(2-aminoethyl)amino]benzo[g]isoquinoline-5,10-dione dimaleate
Salt Composition:
Pixantrone + 2 maleic acid molecules
Molecular Formula:
C₂₅H₂₇N₅O₁₀
Molecular Weight:
557.5 g/mol
CAS Number:
144675-97-8
Pixantrone Dimaleate contains an aza-anthracenedione core with aminoethylamino substituents. PubChem describes pixantrone as a DNA-intercalating compound associated with topoisomerase II inhibition and antineoplastic activity.
Pixantrone Dimaleate is an oncology API associated with the treatment of aggressive B-cell non-Hodgkin lymphomas.
The former EU medicinal product Pixuvri contained pixantrone dimaleate as its active substance and was authorized for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. The EU marketing authorization expired on 12 June 2024 after the marketing-authorisation holder did not apply for renewal.
Pixantrone has antineoplastic activity involving DNA interaction and topoisomerase II-related mechanisms, resulting in inhibition of DNA replication and tumor-cell cytotoxicity.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |