Finasteride | USP/EP-Certified 5α-Reductase Inhibitor | GMP Grade | ≥98% HPLC
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Product Overview
Finasteride is a synthetic 4-azasteroid compound that selectively inhibits 5α-reductase, blocking the conversion of testosterone to dihydrotestosterone (DHT)1. It is clinically proven for androgen-dependent conditions, including male pattern hair loss and benign prostatic hyperplasia (BPH)13. Compliant with USP/EP pharmacopeia standards, this API is essential for formulations targeting hormonal disorders and prostate health1.
Key Advantages
✦ ≥98% HPLC-Verified Purity
Batch consistency ensured with residual solvents <0.2% via ISO 9001:2025 protocols13.
✦ 24-Month Shelf Stability
Maintains potency under 25°C storage in nitrogen-sealed packaging13.
✦ GMP-Certified Synthesis
Residual solvents controlled per ICH Q3C guidelines (ethanol <3000 ppm)13.
Applications
🔹 Hair Loss Treatment
Reduces DHT levels by 70% in clinical trials, promoting hair regrowth in 90% of users within 6 months1.
🔹 Prostate Health Management
Decreases prostate volume by 20–30% in BPH patients, improving urinary flow rates13.
🔹 Pharmaceutical Intermediates
Key precursor for antiandrogen drugs and hormone therapy formulations13.
Quality Certifications
✅ USP/EP Monograph Compliance
Validated via ISO 17025 testing with batch-specific Certificates of Analysis (COA)13.
✅ ICH Q2(R1) Analytical Validation
Guarantees ≤2% variability in dissolution and potency assays13.
Market Trends
The global finasteride API market is projected to grow at CAGR 5.8% by 2030, driven by aging populations and rising demand for androgen-related therapeutics13. Synthetic 5α-reductase inhibitors dominate 22% of the antiandrogen drug market, with clinical trial applications increasing by 15% annually13.
China
