Description

Rucaparib Impurity 9 is a specified organic impurity associated with the active pharmaceutical ingredient Rucaparib. 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 and analytical laboratories in the pharmaceutical industry who require high-purity chemical standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Rucaparib drug substance and finished products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect process-related impurities.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of the API, supporting regulatory filings (e.g., ANDA, NDA).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, aiding in the determination of drug shelf-life.
• Regulatory Compliance: Supports compliance with stringent guidelines from pharmacopoeias (USP, EP) and regulatory bodies (FDA, EMA) regarding impurity profiling and control.
• Research & Development: Facilitates synthetic route optimization and process chemistry studies by identifying and characterizing synthetic intermediates or by-products.

Basic Information

Product Name	Rucaparib Impurity 9
CAS No.	283173-72-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rucaparib Related Compound 9; Rucaparib Impurity; AG-014699 Impurity 9; PF-01367338 Impurity 9; 8-Fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one (IUPAC-based); Rucaparib Process Impurity; Rucaparib Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Rucaparib Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.