Description

Rucaparib Impurity 3 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 primarily used by pharmaceutical manufacturers, analytical laboratories, and contract research organizations (CROs) to ensure the purity, safety, and efficacy of Rucaparib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rucaparib API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance: A critical component in the batch release testing of Rucaparib to ensure it meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings (e.g., FDA, EMA).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during Rucaparib manufacturing.

Basic Information

Product Name	Rucaparib Impurity 3
CAS No.	1577983-65-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rucaparib Related Compound 3; Rucaparib Impurity C; AG-014699 Impurity 3; PF-01367338 Impurity 3; (8-Fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one) derivative; PARP Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Rucaparib Impurity 3 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 detailed chromatographic data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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