Description

Rucaparib Impurity 6 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Rucaparib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by providing a reference point for identification and quantification. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of this targeted cancer therapy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Rucaparib Impurity 6 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of Rucaparib.

Basic Information

Item	Detail
Product Name	Rucaparib Impurity 6
CAS No.	1424059-28-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rucaparib Related Compound 6; Rucaparib Impurity C; 8-Fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one (Potential IUPAC); AG-014699 Impurity 6; PF-01367338 Impurity 6; PARP Inhibitor Impurity Standard
EINECS	Contact for details

Quality Control

Our Rucaparib Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0%; Total impurities ≤ 5.0%
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.