Description

Rucaparib Impurity 2 is a specified impurity of the active pharmaceutical ingredient Rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Rucaparib drug substances and products.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Rucaparib API.
• Critical component in Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for Rucaparib.
• Used in Stability Studies and degradation pathway profiling of Rucaparib formulations.
• Essential for Quality Control (QC) and Quality Assurance (QA) laboratories in pharmaceutical manufacturing.
• Serves as a Research Chemical for studying the metabolism and pharmacokinetics of Rucaparib.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity data for drug master files.

Basic Information

Product Name	Rucaparib Impurity 2
CAS No.	283173-74-0
Molecular Formula	C19H18F2N4O
Molecular Weight	356.37 g/mol
Synonyms	8-Fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one; Rucaparib Related Compound; Rucaparib Impurity B; Rucaparib EP Impurity B; Rucaparib USP Impurity; AG-014699 Impurity; PARP Inhibitor Impurity; PF-01367338 Impurity
EINECS	Contact for details

Quality Control

Our Rucaparib Impurity 2 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against stringent internal specifications. Our quality commitment supports compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. Due to its hygroscopic nature, the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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