Dienestrol is a synthetic non-steroidal estrogen and pharmaceutical active ingredient belonging to the stilbene estrogen class. It produces estrogenic activity by interacting with estrogen receptors and has historically been used in estrogen replacement and local hormonal therapy.
Dienestrol is a synthetic estrogen structurally related to other non-steroidal estrogenic compounds. It is also known as Diethylstilbestrol metabolite-related compound and is primarily associated with topical or local estrogenic applications.
Dienestrol is identified by CAS No. 84-17-3. It has the molecular formula C18H20O2 and a molecular weight of approximately 268.36 g/mol.
Dienestrol exerts estrogenic effects by binding to estrogen receptors (ERα and ERβ). Activation of these receptors influences estrogen-responsive tissues and regulates the expression of various estrogen-dependent genes.
Dienestrol acts as an estrogen receptor agonist. After binding to estrogen receptors, the receptor complex can interact with estrogen-responsive elements and regulate gene transcription.
This estrogenic activity can promote changes in the vaginal and other estrogen-responsive tissues and may help address symptoms associated with estrogen deficiency.
Dienestrol has historically been used in pharmaceutical preparations for:
Its current availability, indications and regulatory status may vary between countries.
Dienestrol may be relevant to pharmaceutical manufacturers and formulation-development organizations working with estrogenic and gynecological pharmaceutical products.
The API may be incorporated into formulation-specific preparations according to the approved product, intended route of administration and applicable regulatory requirements.
Dienestrol API quality evaluation may include:
Testing should be performed using validated analytical methods appropriate for the material and intended pharmaceutical application.
Dienestrol intended for pharmaceutical manufacturing should be handled according to applicable GMP, quality-control and regulatory requirements. Final specifications should be established according to the intended market, applicable pharmacopoeial standards and the manufacturer's approved product specification.
A batch-specific Certificate of Analysis (CoA) should provide relevant analytical results and acceptance criteria.
Dienestrol API should be stored in suitable, tightly closed packaging under the manufacturer's recommended storage conditions. Protection from excessive heat, moisture and unsuitable environmental exposure should be maintained.
Dienestrol is relevant to pharmaceutical companies involved in hormonal therapy, gynecological formulations and estrogen-related pharmaceutical development.
For commercial applications, customers should verify the API grade, identity, assay, purity, impurity profile, regulatory documentation and batch-specific CoA before use.
Consistent Dienestrol API quality is important for reliable formulation and pharmaceutical manufacturing. Control of identity, assay, purity and related substances supports reproducible product quality.
Appropriate documentation may include a Certificate of Analysis, specification sheet, safety documentation and applicable regulatory information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |