Description

Olaparib Impurity 31 is a designated impurity of the active pharmaceutical ingredient Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, quality control, and regulatory compliance. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and quality assurance of Olaparib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Olaparib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Olaparib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Olaparib Impurity 31
CAS No.	458535-34-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 31; AZD-2281 Impurity 31; KU-0059436 Impurity 31; (S)-N-(4-(4-(cyclopropanecarboxamido)methyl)piperidin-1-yl)carbonyl)phenyl)-2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzamide; Olaparib EP Impurity I; Olaparib USP Impurity; PARP Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Olaparib Impurity 31 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests such as HPLC purity, NMR, and mass spectrometry. We adhere to stringent quality management systems to support our clients' needs for reliable reference standards in pharmaceutical development and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated 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)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.