Description

Olaparib Impurity 30 CAS NO 1460272-52-9 is a designated process-related impurity or degradation product of the active pharmaceutical ingredient Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control to ensure the purity and safety of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, purification, and batch release of Olaparib and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Olaparib drug substance and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and accurately measure impurity levels.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity profiles, ensuring compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Process Chemistry Research: Aids in understanding the formation pathway during Olaparib synthesis, helping to refine manufacturing processes to minimize impurity generation.
• Regulatory Submissions: Provides necessary data and characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Item	Detail
Product Name	Olaparib Impurity 30
CAS No.	1460272-52-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olaparib Related Compound 30; Olaparib Impurity C; Olaparib EP Impurity C; (8-Fluoro-2-{[4-(morpholin-4-ylmethyl)phenyl]amino}-5,6-dihydro-4H-pyrrolo[3,2,1-ij]quinolin-1-yl)methanol; AZD-2281 Impurity 30; KU-0059436 Impurity 30
EINECS	Contact for details

Quality Control

Every batch of Olaparib Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) detailing batch-specific results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions 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 ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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