17b-(tert-Butylcarbamoyl)-4-aza-5a-androsten-3-one

‌Finasteride Impurity | Pharmaceutical Reference Standard‌
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‌Product Overview‌
Finasteride Impurity is a high-purity reference material essential for quality control in pharmaceutical manufacturing and analytical research. It serves as a critical standard for HPLC/GC-MS validation, ensuring compliance in API synthesis and drug formulation processes. Widely used in GMP-certified facilities for prostate hyperplasia and alopecia therapeutics development‌13.

‌Key Advantages‌
✔ ‌High Purity‌: >98% certified by HPLC/UV, with single impurity <0.5%‌23
✔ ‌GMP Compliance‌: Manufactured under ISO 9001 and ICH Q7 guidelines‌34
✔ ‌Stability‌: 36-month shelf life at -20°C with batch-specific CoA‌4

‌Applications‌
◈ API synthesis intermediates for 5α-reductase inhibitors‌13
◈ QC testing in anti-androgen drug production‌4
◈ Method development for pharmacopeial standards (EP/BP)‌3

‌Quality Certifications‌
◼ ‌EP/BP/ICH‌ compliant with full analytical reports (IR, NMR, MS)‌34
◼ ‌Stability tested‌: Accelerated & long-term studies per ICH Q1A(R2)‌4

‌Market Trends‌
The global benign prostatic hyperplasia (BPH) treatment market is projected to grow at ‌6.8% CAGR (2025-2030)‌, driven by rising demand for 5α-reductase inhibitors‌14. Over ‌$3.2B‌ is invested annually in androgen-related alopecia R&D, where finasteride remains a gold-standard therapeutic‌34.

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Optimized Keywords: HPLC-Certified Reference Standard, GMP Pharmaceutical Intermediate, 5α-Reductase Inhibitor QC, EP/BP Compliance