Description

Estradiol Hemihydrate is a potent and naturally occurring estrogen steroid hormone, widely recognized as the primary female sex hormone. It is a critical active pharmaceutical ingredient (API) for hormone replacement therapy (HRT) and other endocrine treatments. This high-purity compound is essential for pharmaceutical manufacturers, research institutions, and developers of advanced drug delivery systems globally.

Application

• Pharmaceutical API: Core ingredient in hormone replacement therapy (HRT) products for managing menopausal and postmenopausal symptoms.
• Transdermal Systems: Used in the formulation of patches, gels, and creams for controlled, non-oral delivery.
• Oral Formulations: Key component in tablets and capsules for systemic estrogen therapy.
• Vaginal Applications: Incorporated into creams, rings, and tablets for localized treatment of atrophic vaginitis.
• Veterinary Medicine: Employed in reproductive health management for animals.
• Biochemical Research: Serves as a standard and reagent in endocrinology, oncology, and developmental biology studies.
• Contraceptive Formulations: Used in combination with progestins in certain hormonal contraceptives.

Basic Information

Product Name	Estradiol Hemihydrate
CAS No.	35380-71-3
Molecular Formula	C18H24O2 · ½H2O
Molecular Weight	281.39 g/mol (anhydrous basis)
Synonyms	17β-Estradiol Hemihydrate; Estradiol-17β Hemihydrate; E2 Hemihydrate; Dihydrofolliculin Hemihydrate; Dihydroxyestrin Hemihydrate; Oestradiol Hemihydrate; (17β)-Estra-1,3,5(10)-triene-3,17-diol Hemihydrate
EINECS	Contact for details

Quality Control

Our Estradiol Hemihydrate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Each batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting all critical quality attributes is provided to ensure traceability and support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	1.8% - 2.2%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.