Description

Olaparib Impurity 1 is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Olaparib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the PARP inhibitor drug substance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Olaparib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Olaparib to minimize impurity formation.

Basic Information

Product Name	Olaparib Impurity 1
CAS No.	763113-06-0
Molecular Formula	C24H23FN4O3
Molecular Weight	434.47 g/mol
Synonyms	4-[(3S)-3-(4-Cyclopropanecarbonylpiperazin-1-yl)carbonyl-4-fluorophenyl]methyl]phthalazin-1(2H)-one; Olaparib Related Compound 1; Olaparib Impurity A; AZD-2281 Impurity 1; (S)-N-(4-(4-(Cyclopropanecarbonyl)piperazine-1-carbonyl)-4-fluorobenzyl)-2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzamide (Related Structure); Lynparza Impurity 1; PARP Inhibitor Impurity; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our Olaparib Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. We support compliance with ICH guidelines and can provide materials suitable for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.