Description

Rucaparib Impurity 1 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 serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of this targeted cancer therapy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Rucaparib API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency meets pharmacopeial specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes.

Basic Information

Product Name	Rucaparib Impurity 1
CAS No.	1577999-02-0
Molecular Formula	C19H18FN3O
Molecular Weight	323.37 g/mol
Synonyms	AG-014699 Impurity 1; PF-01367338 Impurity 1; 8-Fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one; Rucaparib Related Compound 1; (Rucaparib) Impurity A (potential); Azepino[5,4,3-cd]indol-6-one, 8-fluoro-2-[4-[(methylamino)methyl]phenyl]-1,3,4,5-tetrahydro-
EINECS	Contact for details

Quality Control

Our Rucaparib Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical characterization to ensure identity, purity, and suitability for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques including HPLC, MS, and NMR. We support compliance with ICH Q3A, Q3B, and pharmacopeial guidelines, and specifications can be aligned with client-specific requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under inert conditions if specified to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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