Description

Olaparib Impurity 56 is a specified organic compound used as a critical reference standard in pharmaceutical development and quality control. This impurity is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Olaparib, a targeted cancer therapy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Olaparib API and its drug products.
• Method Development and Validation (HPLC/LC-MS): Critical for developing and validating chromatographic methods to monitor and control impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and track degradation pathways of Olaparib.
• Quality Control & Batch Release: A necessary component for in-house QC testing to ensure drug substance and product meet stringent regulatory specifications.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing characterized impurity data.
• Research and Development: Used in synthetic chemistry R&D to understand and mitigate impurity formation during the manufacturing process.

Basic Information

Product Name	Olaparib Impurity 56
CAS No.	1956324-57-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 56; Olaparib Impurity CRS; 1956324-57-4; (2R)-2-{4-[(3-{[(3R)-3-Methyl-4-morpholinyl]methyl}phenyl)methyl]-1-piperazinyl}-2-(4-fluorophenyl)acetic Acid (tentative); Unii-XXXX; Olaparib EP Impurity F (tentative); Olaparib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Olaparib Impurity 56 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.