Description

Rucaparib Impurity 5 is a designated impurity standard associated with the active pharmaceutical ingredient (API) Rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable standards to ensure the purity, safety, and efficacy of drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Rucaparib Impurity 5 in API and finished drug product batches.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Rucaparib.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to monitor impurity profiles and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• 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 optimizing synthetic routes and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Rucaparib Impurity 5
CAS No.	1577982-06-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rucaparib Related Compound 5; Rucaparib EP Impurity 5; Rucaparib USP Impurity 5; AG-014699 Impurity 5; PF-01367338 Impurity 5; 8-Fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one Impurity; (Specific IUPAC name to be confirmed)
EINECS	Contact for details

Quality Control

Our Rucaparib Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, 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 to support your regulatory and quality needs.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. 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)	Individual unknown 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.