Description

Olaparib Impurity 11 is a designated process-related impurity and degradation product of the active pharmaceutical ingredient Olaparib, a PARP inhibitor used in targeted cancer therapy. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing and quality assurance. It is an essential material for analytical method development and validation, stability studies, and regulatory compliance submissions within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Olaparib drug substance and drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Crucial for developing and validating stability-indicating methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in-house by manufacturers and by third-party testing laboratories to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to identify and track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Documentation: Supports Investigational New Drug (IND), New Drug Application (NDA), and Marketing Authorization Application (MAA) filings by providing impurity identification and qualification data.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Olaparib, informing improved formulation and packaging strategies.

Basic Information

Item	Detail
Product Name	Olaparib Impurity 11
CAS No.	1956340-97-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 11; Olaparib Impurity; 4-[[4-[(3S)-3-Methyl-4-morpholinyl]phenyl]amino]-5-(trifluoromethyl)-2-pyrimidinamine; UNII-9Q4XH5U4V5; (S)-N-(4-(4-Methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)-4-((tetrahydro-2H-pyran-4-yl)amino)benzamide Impurity; AZD-2281 Impurity 11; KU-0059436 Impurity 11
EINECS	Contact for details

Quality Control

Every batch of Olaparib Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical quality attributes.

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 compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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