Description

Olaparib Impurity 25 is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Olaparib. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product by accurately identifying and quantifying this specific impurity. It is essential for professionals engaged in process development, stability studies, and regulatory compliance within the oncology drug development sector.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Olaparib API and its drug formulations.
• Method Development & Validation: Critical for developing, optimizing, and validating analytical methods such as HPLC and LC-MS in quality control laboratories.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Olaparib.
• Process Chemistry R&D: Aids chemists in identifying and minimizing the formation of this impurity during the synthesis and purification process of Olaparib.
• Quality Assurance/Control (QA/QC): Serves as a benchmark for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Olaparib Impurity 25
CAS No.	1423030-11-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 25; Olaparib EP Impurity 25; Olaparib USP Impurity 25; AZD-2281 Impurity 25; (S)-N-(4-((4-((3-(4-(Cyclopropylcarbonyl)piperazin-1-yl)carbonyl)-4-fluorophenyl)methyl)carbamoyl)phenyl)-3,4-dihydro-2H-pyrano[2,3-b]quinoline-8-carboxamide (proposed); UNII-Contact for details; PARP Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Olaparib Impurity 25 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and assay is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.