Description

Olaparib Impurity 15 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Olaparib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and regulatory compliance testing for this important oncology therapeutic.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Olaparib API.
• Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Batch Release: Essential for establishing impurity limits and ensuring batch-to-batch consistency in Olaparib manufacturing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing identified impurity data for drug master files.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Research into Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Olaparib.

Basic Information

Product Name	Olaparib Impurity 15
CAS No.	2250243-17-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 15; Olaparib Impurity; 2250243-17-3; PARP Inhibitor Impurity; 4-[[4-Fluoro-3-[(4-methoxy-1-piperidinyl)carbonyl]phenyl]methyl]-1(2H)-phthalazinone Impurity; (S)-N-(5-((4-(4-Fluorobenzyl)piperazin-1-yl)methyl)-2-methoxyphenyl)-4-(4-methylpiperazin-1-yl)benzamide Impurity (Check with supplier for exact structural identity)
EINECS	Contact for details

Quality Control

Every batch of Olaparib Impurity 15 is characterized and qualified to the highest standards to ensure its suitability as a reference material. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and lot-to-lot consistency. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing the analytical results and confirming compliance with specified standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (typically 15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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