Description

Olaparib Impurity 14 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Olaparib. This compound is critical for ensuring the purity, safety, and efficacy of Olaparib, a key PARP inhibitor used in targeted cancer therapy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

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: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure Olaparib batches meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in Olaparib under various stability conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in R&D to understand the synthesis pathway, degradation mechanisms, and to establish impurity control strategies.

Basic Information

Product Name	Olaparib Impurity 14
CAS No.	2250242-62-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 14; Olaparib Impurity; PARP Inhibitor Impurity; 4-[[4-Fluoro-3-[(4-methoxy-1-piperidinyl)carbonyl]phenyl]methyl]-1(2H)-phthalazinone Impurity; (2S)-2-Fluoro-5-[(4-oxo-3,4-dihydrophthalazin-1-yl)methyl]-N-[4-(morpholin-4-ylmethyl)phenyl]benzamide Impurity; AZD-2281 Impurity 14; KU-0059436 Impurity 14
EINECS	Contact for details

Quality Control

Our Olaparib Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, 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.

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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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