Mitoxantrone is a synthetic anthracenedione antineoplastic agent used in oncology and certain neurological indications. It acts as a DNA-reactive agent and topoisomerase II inhibitor, producing DNA cross-links and strand breaks that interfere with DNA and RNA synthesis and contribute to cytotoxic activity.
Mitoxantrone is primarily administered as mitoxantrone hydrochloride, particularly in pharmaceutical formulations intended for intravenous use. The hydrochloride form is the active pharmaceutical substance used in products such as mitoxantrone injection.
Mitoxantrone is a specialized oncology and neurological pharmaceutical API requiring stringent control of assay, related substances, degradation products, residual solvents, water content and other critical quality attributes.
CAS Number: 65271-80-9
Mitoxantrone Hydrochloride CAS: 70476-82-3
Molecular Formula: C22H28N4O6
Molecular Weight: 444.50 g/mol
Mitoxantrone Hydrochloride Formula: C22H28N4O6·2HCl
Mitoxantrone Hydrochloride Molecular Weight: 517.40 g/mol
Drug Class: Anthracenedione Antineoplastic Agent
Therapeutic Class: Antineoplastic Agent
Therapeutic Areas: Oncology / Neurology
Molecule Type: Synthetic Small Molecule
PubChem lists mitoxantrone at 444.5 g/mol and identifies 70476-82-3 as the hydrochloride-related CAS; the USP monograph gives the hydrochloride molecular weight as 517.40.
Mitoxantrone is a DNA-reactive antineoplastic agent. It intercalates into DNA and causes DNA cross-links and strand breaks. It also inhibits topoisomerase II, an enzyme involved in DNA uncoiling and repair. These activities interfere with DNA and RNA synthesis and produce cytotoxic effects.
Mitoxantrone API is associated with pharmaceutical applications involving:
Mitoxantrone has been used for certain forms of leukemia, lymphoma and advanced prostate cancer, and for specific progressive or worsening forms of multiple sclerosis.
Mitoxantrone hydrochloride is primarily formulated as:
The FDA labeling describes mitoxantrone hydrochloride as a synthetic antineoplastic anthracenedione for intravenous use.
Mitoxantrone hydrochloride is described as a blue-black solid. PubChem reports a melting point of approximately 203–205°C and describes it as sparingly soluble in water.
A controlled Mitoxantrone API manufacturing process may involve:
Typical Mitoxantrone Hydrochloride API testing includes:
The USP monograph specifies that Mitoxantrone Hydrochloride contains 97.0%–102.0% of mitoxantrone hydrochloride, calculated on the anhydrous basis.
Store Mitoxantrone API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Storage requirements should follow the applicable approved API specification and stability data.
Mitoxantrone is relevant to research involving:
Mitoxantrone is a synthetic anthracenedione antineoplastic agent with CAS Number 65271-80-9, molecular formula C22H28N4O6, and molecular weight 444.50 g/mol. Its commonly used pharmaceutical salt, Mitoxantrone Hydrochloride, has molecular weight 517.40 g/mol and CAS 70476-82-3.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 3.0–4.5 |
| Individual Impurity | ≤0.10% |
| Total Impurities | ≤0.50% |
| Water Content | NMT 1.0% |