Estradiol Hemihydrate (CAS 35380-71-3)
Google Keywords: Estradiol Hemihydrate CAS 35380-71-3, Estrogen API Manufacturing, HRT Drug Synthesis, Hormone Replacement Therapy, GMP Pharmaceutical Intermediates
🌟 Product Overview
Estradiol Hemihydrate (CAS 35380-71-3) is a semi-hydrated crystalline form of estradiol, a potent estrogen hormone critical for hormone replacement therapy (HRT), contraceptive formulations, and menopausal symptom management. As a high-purity intermediate, it enables precise synthesis of estradiol-based APIs, ensuring therapeutic efficacy in regulating endocrine functions and reproductive health.
Primary Function: Key intermediate for producing estradiol APIs and formulations with controlled bioavailability.
Applications: HRT drug development, contraceptive manufacturing, and treatment of estrogen deficiency disorders.
✅ Key Advantages
🔹 Ultra-High Purity | ≥99.0% (HPLC/GC verified) | Complies with ICH Q11 guidelines for pharmaceutical intermediates.
🔹 Enhanced Stability | Hemihydrate form ensures optimal shelf-life and resistance to degradation under controlled conditions.
🔹 Regulatory Readiness | Fully characterized (NMR, FTIR, XRPD) to support FDA/EMA filings and GMP compliance.
🧪 Applications
API Manufacturing: Essential for synthesizing estradiol in HRT drugs, transdermal patches, and oral tablets.
Contraceptive Formulations: Used in combination therapies to regulate ovulation and hormonal balance.
Clinical Research: Supports studies on estrogen receptor modulation and osteoporosis prevention.
📜 Quality Assurance
Testing Methods: HPLC, GC, NMR, FTIR, and X-ray powder diffraction (XRPD) for structural validation and impurity profiling.
Standards: Meets USP <1086>, EP 10.0, and ISO 9001:2015 certified production protocols.
📈 Market Trends
The global hormone replacement therapy market is projected to exceed $33 billion by 2030 (CAGR 6.3%), driven by aging populations, rising awareness of menopausal health, and demand for personalized estrogen therapies. Estradiol intermediates like this hemihydrate form are pivotal in scaling production of FDA-approved HRT solutions.
Accelerate your hormone therapy production with Estradiol Hemihydrate – precision-crafted for purity, stability, and regulatory alignment.
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