Estrone | USP/EP-Compliant Steroid API | GMP-Certified Hormone Intermediate
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Product Overview
Estrone, a key estrogen steroid hormone, is widely utilized as a high-purity intermediate in pharmaceutical synthesis and hormone therapy research13. As a primary precursor for estrogen derivatives, it supports the development of hormone replacement therapies (HRT), metabolic disorder treatments, and biochemical assay reagents23. Its compliance with USP/EP pharmacopeia standards ensures reliability in API manufacturing and laboratory applications14.
Key Advantages
✔ ≥98% HPLC-Purity: Meets USP/EP specifications for steroid APIs, validated by third-party testing12.
✔ Stability Guaranteed: 36-month shelf life under controlled storage (2-8°C, inert gas-packed)34.
✔ GMP-Certified Production: Full traceability with COA, residual solvent (<30 ppm), and heavy metal analysis13.
Applications
◈ Hormone Replacement Therapy: Core ingredient for estrogen-based HRT formulations23.
◈ Metabolic Disease Research: Study of estrogen-related pathways in osteoporosis and menopause34.
◈ Pharmaceutical Exports: Bulk API for global drug manufacturers and compounding pharmacies14.
Quality Certifications
■ USP <467> Compliance: Residual solvents (e.g., methanol, acetone) below 50 ppm12.
■ ISO 9001:2025: Audited synthesis processes with ≤1% batch-to-batch variability34.
Market Trends
The global estrogen intermediates market is forecasted to grow at CAGR 7.2% through 2028, driven by rising HRT demand in aging populations13. Estrone accounts for 22% of steroid API exports in Europe and North America, with 15% annual growth in biopharma R&D applications23.
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