17-Beta Estradiol Hemihydrate API Active Pharmaceutical Ingredient For Hormone Preparation CAS 35380-71-3

Estradiol hemihydrate More Info

Estradiol hemihydrate is the hemihydrate crystalline form of β-estradiol, the most potent and naturally predominant estrogen hormone in humans. Chemically, it consists of two molecules of estradiol (C₁₈H₂₄O₂) associated with one molecule of water, giving it the molecular formula C₃₆H₅₀O₅ and a molecular weight of approximately 562.8 g/mol. The compound appears as a white or creamy white crystalline powder that is odorless, hygroscopic, and light-sensitive. Its solubility profile is notable: it is practically insoluble in water, soluble in alcohol and solutions of fixed alkali hydroxides, and sparingly soluble in vegetable oils. This specific crystalline form serves as the standardized pharmaceutical grade of estradiol, recognized by major pharmacopeias including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia.

Upon administration, estradiol hemihydrate acts as a potent agonist of the estrogen receptor, binding to both ERα and ERβ subtypes with high affinity. The hormone-receptor complex diffuses into the cell nucleus, where it binds to estrogen response elements (EREs) on DNA and activates the transcription of genes involved in female reproductive function, secondary sex characteristics, and the maintenance of various target tissues. These tissues include the reproductive tract (uterus, vagina, fallopian tubes), breast, pituitary gland, hypothalamus, liver, and bone. Beyond its classical genomic actions, estradiol also initiates rapid, non-genomic signaling through membrane-associated estrogen receptors, influencing cellular processes within minutes.

In clinical practice, estradiol hemihydrate serves as a cornerstone of menopausal hormone therapy (MHT), where it is used to alleviate vasomotor symptoms such as hot flashes and night sweats, as well as to treat vulvar and vaginal atrophy. It is also indicated for the prevention of postmenopausal osteoporosis and for the management of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. In reproductive medicine, estradiol hemihydrate is employed for endometrial priming prior to embryo transfer during in vitro fertilization (IVF) cycles, where it promotes endometrial development and improves implantation outcomes. Clinical formulations include oral tablets, transdermal patches and gels, vaginal tablets and rings, and injectable preparations, allowing route selection based on patient needs and tolerability.

The physicochemical properties of estradiol hemihydrate have important implications for pharmaceutical formulation and handling. The hemihydrate form is distinct from the anhydrous form (CAS 50-28-2) of estradiol, and the two are not interchangeable without appropriate adjustments due to differences in molecular weight and water content. For laboratory storage, the compound should be kept in tight, light-resistant containers at controlled room temperature (15-25°C) or under refrigerated conditions (as recommended by pharmacopeial standards, +5°C ± 3°C) to prevent degradation. As a formulation derivative, micronized preparations (with 95% of particles below 10 μm) are commonly used to enhance dissolution and bioavailability. The compound is classified as a hazardous drug by NIOSH and carries hazard warnings for carcinogenicity (Category 2), reproductive toxicity (Category 1A), and aquatic toxicity (Categories 1).

The safety considerations for estradiol hemihydrate therapy reflect its potent hormonal activity. In women with an intact uterus, unopposed estrogen therapy significantly increases the risk of endometrial hyperplasia and endometrial carcinoma, necessitating concurrent progestin administration for endometrial protection. Long-term use has been associated with an increased risk of venous thromboembolism, stroke, and breast cancer in certain patient populations, particularly with oral formulations. For research applications, estradiol hemihydrate is strictly intended for laboratory use only and is not for human or veterinary therapeutic purposes unless explicitly specified in approved formulations. Available research grades typically have purity specifications of 95% or higher, meeting USP reference standard requirements of 97.0-103.0% of C₁₈H₂₄O₂ calculated on the anhydrous basis.

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