?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 development?13.

?Key Advantages?
? ?High Purity?: >98% certified by HPLC/UV, with single impurity <0.5%?23
? ?GMP Compliance?: Manufactured under ISO 9001 and ICH Q7 guidelines?34
? ?Stability?: 36-month shelf life at -20°C with batch-specific CoA?4

?Applications?
? API synthesis intermediates for 5α-reductase inhibitors?13
? QC testing in anti-androgen drug production?4
? 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 inhibitors?14. Over ?$3.2B? is invested annually in androgen-related alopecia R&D, where finasteride remains a gold-standard therapeutic?34.

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