Description

Olaparib Impurity 58 is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Olaparib. This impurity 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 activities within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Olaparib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Olaparib meets stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and scale-up of Olaparib manufacturing processes.

Basic Information

Product Name	Olaparib Impurity 58
CAS No.	848136-41-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 58; Olaparib Impurity 58; AZD-2281 Impurity 58; 4-[[4-Fluoro-3-[(4-methoxy-1-piperidinyl)carbonyl]phenyl]methyl]-1(2H)-phthalazinone Impurity; KU-0059436 Impurity 58; Lynparza Impurity 58; (3S)-4-{4-Fluoro-3-[(4-methoxy-1-piperidinyl)carbonyl]benzyl}-1(2H)-phthalazinone Impurity
EINECS	Contact for details

Quality Control

Every batch of Olaparib Impurity 58 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced analytical techniques, including HPLC, GC, MS, and NMR. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.