?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?

1. ?Testing Methods?: HPLC, GC, NMR, FTIR, and X-ray powder diffraction (XRPD) for structural validation and impurity profiling.

2. ?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.