Description

Niraparib Metabolite M1 CAS NO 1476777-06-6 is a key pharmacologically active metabolite of the PARP inhibitor niraparib, which is used in the treatment of certain cancers. This compound is of critical importance for pharmaceutical research and development, particularly in the areas of drug metabolism and pharmacokinetics (DMPK) studies and bioanalytical method development. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in oncology drug development, metabolite profiling, and regulatory submission support.

Application

• Reference Standard for Bioanalysis: Serves as a critical certified reference material (CRM) for the quantification of niraparib and its metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS and HPLC methods.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and exposure-response relationships of niraparib in preclinical and clinical research.
• Pharmacological Research: Employed in vitro and in vivo studies to understand the contribution of M1 to the overall efficacy and safety profile of the parent drug niraparib.
• Impurity Profiling and Characterization: Acts as an identified impurity standard for the quality control of niraparib active pharmaceutical ingredient (API) and finished drug products, ensuring compliance with ICH guidelines.
• Regulatory Documentation: Essential for preparing Investigational New Drug (IND) and New Drug Application (NDA) submissions to health authorities like the FDA and EMA.
• Clinical Trial Support: Utilized in the bioanalytical phase of clinical trials to monitor patient metabolite levels and correlate with clinical outcomes.

Basic Information

Product Name	Niraparib Metabolite M1
CAS No.	1476777-06-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	M1 metabolite of Niraparib; Niraparib M1; Niraparib Metabolite; N-(4-(4-(Dimethylamino)piperidine-1-carbonyl)phenyl)-2-(4-fluorophenyl)-5,6-dihydro-4H-pyrrolo[3,2,1-ij]quinolin-1(2H)-one metabolite; PARP Inhibitor Metabolite; ZEJULA Metabolite; MK-4827 Metabolite
EINECS	Contact for details

Quality Control

Our Niraparib Metabolite M1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with relevant guidelines for reference standards. Our quality commitment supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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