N-T-BUTYL-4-ANDROSTEN-3-ONE-17BETA-CARBOXAMIDE

Finasteride Impurity 5‌
‌CAS:‌ 131267-80-6| ‌Molecular Formula:‌ C₂₃H₃₆N₂O₂ | ‌Category:‌ Pharmaceutical Impurity Standards

🌟 ‌Product Overview‌

Finasteride Impurity 5 is a ‌high-purity reference standard‌ critical for ‌drug development‌ and ‌quality control‌ in API manufacturing. It serves as a ‌synthesis intermediate‌ and analytical marker for HPLC/GC testing, ensuring compliance with ‌ICH guidelines‌ and ‌regulatory submissions‌ ‌13.

🔑 ‌Key Advantages‌

🎯 ‌Applications‌

• ‌API Development‌

  : Key intermediate for Finasteride synthesis ‌34

• ‌QC Laboratories‌

  : Calibration of impurity quantification in finished drugs ‌16

• ‌Regulatory Support‌

  : FDA/EMA submission-ready data packages ‌2

• ‌Academic Research‌

  : Stability studies and degradation pathway analysis ‌4

📑 ‌Quality Certifications‌

• ‌ISO 17025‌

   accredited analytical testing ‌5

• ‌USP/EP‌

   method validation compatibility ‌12

• ‌Stability‌

  : 24-month shelf life at -20°C (accelerated studies compliant with ICH Q1A) ‌36

📈 ‌Market Trends‌

The global ‌pharmaceutical impurity analysis market‌ is projected to grow at ‌8.2% CAGR (2025-2030)‌¹, driven by stringent regulatory requirements for ‌generic drug approvals‌. Finasteride generics alone account for ‌$1.2B annual sales‌², emphasizing demand for ‌certified impurity standards‌‌12.