Finasteride Impurity 5?
?CAS:? 131267-80-6| ?Molecular Formula:? C??H??N?O? | ?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 sales?², emphasizing demand for ?certified impurity standards??12.