Description

Niraparib Tosylate CAS NO 1613220-15-7 is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) salt form. This compound is of significant commercial and research interest as the tosylate salt of Niraparib, a potent and selective poly (ADP-ribose) polymerase (PARP) inhibitor. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions engaged in oncology drug development and production.

Application

• Pharmaceutical API Synthesis: Key intermediate in the commercial-scale manufacturing of the finished drug product Niraparib.
• Oncology Research: Used in preclinical and clinical research studies targeting cancers with homologous recombination deficiency (HRD), such as ovarian, breast, and prostate cancers.
• Formulation Development: Serves as the active ingredient for developing various dosage forms, including tablets and capsules, due to its improved physicochemical properties.
• Reference Standard: Employed as a certified reference material (CRM) for quality control and analytical method validation in pharmaceutical laboratories.
• Process Chemistry & Scale-Up: Utilized in process optimization, impurity profiling, and regulatory filing activities for ANDA/NDA submissions.

Basic Information

Product Name	Niraparib Tosylate
CAS No.	1613220-15-7
Molecular Formula	C26H30ClN7O3S
Molecular Weight	548.09 g/mol
Synonyms	Niraparib 4-Methylbenzenesulfonate; Niraparib Tosylate Salt; Niraparib p-Toluenesulfonate; ZEJULA Tosylate; MK-4827 Tosylate; 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide 4-methylbenzenesulfonate; (S)-2-(4-(3-Piperidinyl)phenyl)-2H-indazole-7-carboxamide 4-methylbenzenesulfonate
EINECS	Contact for details

Quality Control

Our Niraparib Tosylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral purity determination, residual solvent analysis (ICH Q3C), and identification by spectroscopic methods. A Certificate of Analysis (COA) detailing all specifications and test results is provided with every shipment to ensure traceability and compliance with cGMP guidelines for pharmaceutical intermediates.

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 material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Chiral Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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