Bicalutamide

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GRAND WUYAO (JIANGSU) PHARMACEUTICAL CO., LTD

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

8/10

Product Information

  • Active Ingredients:Bicalutamide
  • Chemical Formula:C₁₈H₁₆F₄N₂O₄S
  • Molecular Weight:430.40
  • Pharmacopeia:USP
  • Package Type:1kg
  • Shelf Life:2 years
  • Storage:Protected from light
  • Place of Origin:China

Description

Basic Information
  • English Name: Bicalutamide
  • CAS Number: 90357-06-5
  • Molecular Formula: C₁₈H₁₆F₄N₂O₄S
  • Molecular Weight: 430.40 g/mol
  • ATC Code: L02BZ03 (Antineoplastic agents, hormonal preparations)


Structural Characteristics
  • Chemical 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 Properties
  • Therapeutic 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 Specifications
  • Pharmacopoeia 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 Handling
  • Storage Conditions: Store in a dry, cool place, protected from light and heat.


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