Description

Olaparib is a potent and selective poly (ADP-ribose) polymerase (PARP) inhibitor, a critical class of targeted cancer therapeutics. It is a first-in-class oral medication that exploits synthetic lethality in cancer cells with homologous recombination repair deficiencies, such as those harboring BRCA mutations. This product is essential for pharmaceutical manufacturers and research institutions developing and producing advanced oncology treatments, including tablets and capsules for clinical use.

Application

• Oncological Drug Substance: Primary active pharmaceutical ingredient (API) in the formulation of oral anti-cancer medications.
• BRCA-Mutated Cancers: Treatment of advanced ovarian, breast, pancreatic, and prostate cancers with specific genetic biomarkers.
• Pharmaceutical R&D: Key reference standard and building block in discovery programs for novel PARP inhibitors and combination therapies.
• Clinical Trial Material: Sourcing of high-purity API for use in Phase I-III clinical studies globally.
• Generic Drug Manufacturing: Active ingredient for the production of bioequivalent formulations following patent expiry.

Basic Information

Product Name	Olaparib
CAS No.	937799-91-2
Molecular Formula	C24H23FN4O3
Molecular Weight	434.47 g/mol
Synonyms	AZD-2281; KU-0059436; Lynparza (trade name); 4-[[3-[4-(Cyclopropylcarbonyl)piperazin-1-yl]carbonyl]-4-fluorophenyl]methyl(2H)phthalazin-1-one; (2R)-2-Methyl-4-[[(7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-6-yl)carbonyl]amino]-N-(2-pyridinyl)butanamide (related isomer); PARP Inhibitor AZD2281; Olaparibum
EINECS	Contact for details

Quality Control

Our Olaparib is manufactured under strict quality management systems, targeting purity levels suitable for pharmaceutical applications. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as per ICH guidelines. We ensure compliance with relevant pharmacopeial standards and support our partners with the documentation required for regulatory submissions.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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