Description

Niraparib is a potent and selective poly (ADP-ribose) polymerase (PARP) inhibitor, a critical class of targeted cancer therapeutics. Its primary value lies in its mechanism of action, which exploits synthetic lethality in cancer cells with homologous recombination repair deficiencies, such as those harboring BRCA mutations. This product is essential for pharmaceutical research and development, specifically targeting the formulation of oncology drugs for the treatment of ovarian cancer, breast cancer, and other solid tumors. Global suppliers require high-purity, reliable sources of this active pharmaceutical ingredient (API) to support clinical trials and commercial manufacturing.

Application

• Oncology Drug Development: Primary active pharmaceutical ingredient (API) for the formulation of targeted cancer therapies.
• PARP Inhibitor Research: Key reference standard and biochemical tool for studying DNA damage response and repair pathways in preclinical research.
• Pharmaceutical Intermediates: Serves as a crucial intermediate in the synthesis of final drug products and related analogs.
• Clinical Trial Material: Sourced for use in Phase I-III clinical studies evaluating efficacy in various cancers.
• Mechanistic Studies: Used in vitro and in vivo to investigate synthetic lethality and combination therapy strategies.
• Generic Drug Manufacturing: Sourced by manufacturers for the production of generic versions following patent expiration.

Basic Information

Product Name	Niraparib
CAS No.	1038915-60-4
Molecular Formula	C19H20N4O
Molecular Weight	320.39 g/mol
Synonyms	Niraparib; MK-4827; ZEJULA (trade name); 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide; Benzamide, 2-[4-[(3S)-3-piperidinyl]phenyl]-2H-indazole-7-; UNII-8046V22A2P; MK4827
EINECS	Contact for details

Quality Control

Our Niraparib is manufactured under strict quality management systems to ensure it meets the exacting standards required for pharmaceutical use. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via advanced techniques like HPLC and LC-MS. We provide full traceability and Certificates of Analysis (COA) that detail compliance with in-house specifications aligned with ICH guidelines. Our commitment to cGMP principles ensures consistency, reliability, and regulatory support for our global clientele.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccated environment to maintain stability and potency. The container should be kept tightly sealed when not in use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm
Loss on Drying	≤0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.