Lurbinectedin is a synthetic antineoplastic agent belonging to the tetrahydroisoquinoline family of compounds. It is a DNA-binding transcription inhibitor that interacts with DNA and inhibits transcription, while also producing DNA damage and affecting the tumor microenvironment.
Lurbinectedin is primarily used in oncology for the treatment of metastatic small-cell lung cancer (SCLC) in patients whose disease has progressed after platinum-based chemotherapy.
Lurbinectedin is a specialized oncology pharmaceutical API used in the development and manufacture of anticancer drug products. Due to its complex structure and potent biological activity, its production requires stringent process controls, impurity profiling and validated analytical methods.
Key API quality attributes include identity, assay, related substances, residual solvents, water content, elemental impurities and stability characteristics.
CAS Number: 497932-97-9
Molecular Formula: C41H44N4O10
Molecular Weight: 784.82 g/mol
Synonym: Lurbinectedin
Development Code: PM01183
Drug Class: Antineoplastic Agent
Therapeutic Class: Anticancer Agent
Therapeutic Area: Oncology
Molecule Type: Synthetic Small Molecule
Lurbinectedin binds to DNA, particularly at guanine-containing sequences, and forms adducts that interfere with DNA-dependent transcription.
Its pharmacological activity includes:
Lurbinectedin also affects transcriptionally active oncogenic pathways, contributing to its antitumor activity.
Lurbinectedin API is used in pharmaceutical development for:
Lurbinectedin is primarily associated with the treatment of metastatic small-cell lung cancer following progression after platinum-containing chemotherapy.
Its ability to interfere with transcription and induce DNA damage makes it an important compound in small-cell lung cancer and oncology research.
Lurbinectedin is a complex, highly functionalized synthetic molecule. Pharmaceutical-grade material is handled under controlled conditions to maintain its chemical integrity and purity.
A controlled Lurbinectedin API manufacturing process may involve:
Because of its complex molecular structure, manufacturing requires stringent control of stereochemistry, process impurities and degradation products.
Typical Lurbinectedin API testing may include:
Store Lurbinectedin API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage requirements should follow the manufacturer's validated stability data and approved specification.
Lurbinectedin is relevant to research involving:
Lurbinectedin is a DNA-binding antineoplastic API with CAS Number 497932-97-9, molecular formula C41H44N4O10, and molecular weight 784.82 g/mol. It inhibits transcription and induces DNA damage and is primarily associated with oncology applications, particularly metastatic small-cell lung cancer.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |