Structural CharacteristicsChemical Structure: A non-steroidal anti-androgen drug, containing a 4- nitro-3-(trifluoromethyl)phenyl ring and a sulfonamide group.Mechanism of Action: Competitively binds to androgen receptors in prostate tissue, blocking androgen-mediated gene expression and inhibiting tumor cell growth.
Pharmacological PropertiesTherapeutic Use:Used in advanced prostate cancer (as part of androgen deprivation therapy, often combined with a luteinizing hormone-releasing hormone (LHRH) agonist).Route of Administration: Oral administration (tablets).Pharmacokinetics:Well-absorbed after oral intake, highly protein-bound (≥96%).Metabolized in the liver via cytochrome P450 enzymes (CYP3A4 and CYP2C9), with urine and feces as primary excretion routes.
Standards and SpecificationsPharmacopoeia Compliance: Complies with USP, EP, ChP, and other major pharmacopoeial standards.Key Quality Indicators:Purity: ≥99.0% (HPLC).Related Substances: Strict limits for impurities (e.g., degradation products, isomers).Residual Solvents, Heavy Metals, Moisture Content, and Microbiological Tests.
Storage and HandlingStorage Conditions: Store in a dry, cool place, protected from light and heat.
