Niraparib, sold under the brand name Zejula, is an anti-cancer medication used for the treatment of epithelial ovarian, fallopian tube, and primary peritoneal cancer. It is an oral PARP (poly ADP-ribose polymerase) inhibitor, which works by blocking DNA repair mechanisms in cancer cells, leading to cell death, particularly in tumors with BRCA mutations or homologous recombination deficiency (HRD). Niraparib is commonly used as a maintenance therapy after chemotherapy to prevent cancer recurrence.
Parent: Niraparib / Niraparib Tosylate Monohydrate
Parent: Niraparib
Parent: Niraparib
Impurities in Niraparib can arise from chemical synthesis, degradation, or storage conditions. Regulatory agencies such as the FDA, ICH, and EMA enforce strict impurity limits to ensure drug safety and efficacy.
Process-Related Impurities
• Unreacted intermediates from chemical synthesis
• Residual solvents (e.g., methanol, ethanol, acetone)
• By-products from manufacturing processes
Degradation Impurities
• Oxidation by-products due to exposure to oxygen or light
• Hydrolysis impurities caused by moisture
• Thermal degradation products from high-temperature storage
Elemental Impurities
• Heavy metals from catalysts used in synthesis
• Trace levels of arsenic, cadmium, lead, and mercury
Analytical Techniques for Impurity Detection
• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Mass Spectrometry (MS)
• Fourier-Transform Infrared Spectroscopy (FT-IR)
No, Niraparib is not a traditional chemotherapy drug. It is a targeted therapy classified as a PARP inhibitor, which works by blocking cancer cells’ ability to repair DNA damage, leading to cancer cell death.
Niraparib belongs to the class of PARP (poly ADP-ribose polymerase) inhibitors, a group of drugs that prevent cancer cells from repairing DNA damage, making them more vulnerable to destruction.
The duration of Niraparib treatment depends on:
• Effectiveness – Patients may continue treatment as long as the cancer does not progress.
• Side effects – If severe side effects occur, the dose may be adjusted or discontinued.
• Clinical response – Some patients remain on Niraparib for months to years as a maintenance therapy.
Yes, Niraparib can help shrink tumors, especially in patients with BRCA mutations or homologous recombination deficiency (HRD-positive cancers). However, it is primarily used as a maintenance therapy to prevent cancer recurrence rather than as a first-line treatment for shrinking tumors.
