Structural CharacteristicsChemical Structure: A poly(ADP-ribose) polymerase (PARP) inhibitor, featuring a phthalazine core linked to a piperidinyl-pyrimidine moiety.Mechanism of Action: Inhibits PARP1/2 enzymes, disrupting DNA repair in tumor cells with homologous recombination deficiencies (e.g., BRCA-mutated cancers), leading to synthetic lethality.
Pharmacological PropertiesTherapeutic Use:Indicated for:Ovarian cancer (advanced, recurrent, BRCA-mutated).Breast cancer (hereditary, BRCA-mutated, HER2-negative).Prostate cancer (metastatic, homologous recombination repair-deficient).Pancreatic cancer (BRCA-mutated, advanced).Route of Administration: Oral administration (tablets/capsules).Pharmacokinetics:Moderately absorbed, with peak plasma concentration reached in 1–3 hours.Metabolized primarily by CYP3A4/5; excreted in feces (77%) and urine (14%).
Standards and SpecificationsPharmacopoeia Compliance: Meets USP, EP, ChP, and other major pharmacopoeial standards.Key Quality Indicators:Purity: ≥99.0% (HPLC).Related Substances: Strict control of impurities (e.g., desmethyl olaparib, oxidative products).Residual Solvents (e.g., ethanol, dichloromethane), Heavy Metals, Moisture Content, and Microbiological Tests.
Storage and HandlingStorage Conditions: Store in a dry, sealed container at room temperature (10–30°C), protected from light and moisture.
