Mestranol is a synthetic estrogenic compound and a 3-methyl ether derivative of ethinyl estradiol. It is an orally active estrogen that has been used historically as an estrogen component in hormonal contraceptive formulations and other estrogen-containing pharmaceutical preparations.
Mestranol is metabolically converted to ethinyl estradiol in the body and produces estrogenic effects through activation of estrogen receptors.
Mestranol has the molecular formula C21H26O2 and a molecular weight of approximately 310.43 g/mol. Its CAS Number is 72-33-3.
It is a synthetic steroidal estrogen belonging to the estrane class. The molecule contains an ethinyl group and a methoxy substituent and is structurally related to ethinyl estradiol.
Mestranol is converted metabolically to ethinyl estradiol, which binds to estrogen receptors and produces estrogenic effects.
In combination hormonal contraceptive formulations, estrogenic activity contributes to suppression of gonadotropin secretion and helps prevent ovulation when used with an appropriate progestin.
Mestranol has been used historically in:
Its current pharmaceutical use depends on the regulatory status and formulation requirements of the relevant market.
Mestranol API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residue on ignition, residual solvents and elemental impurities, as applicable.
Chromatographic and spectroscopic methods such as HPLC and infrared spectroscopy may be used for identification, assay and impurity profiling.
Final acceptance criteria should follow the applicable manufacturer's validated drug-substance specification and current Certificate of Analysis.
Mestranol should be stored in a tightly closed pharmaceutical-grade container in a cool, dry environment and protected from excessive heat, moisture and direct light.
Specific storage requirements should follow the manufacturer's approved specification.
Mestranol API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Mestranol is a specialized steroidal pharmaceutical API used historically in estrogen-containing and hormonal contraceptive formulations. Product specifications, Certificate of Analysis, analytical documentation and packaging information can be provided according to applicable requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |
| Melting Point | Approximately 148–154 °C |