Mestranol is a pharmaceutical-grade synthetic estrogenic Active Pharmaceutical Ingredient (API) belonging to the estrogen class of steroidal compounds. It is the 3-methyl ether of ethinylestradiol and is also known as 3-methoxy-17α-ethynylestradiol and 17α-ethynylestradiol 3-methyl ether. MEDIOCON INC supplies Mestranol API for pharmaceutical formulation, analytical development and bulk API requirements.
Mestranol has the chemical formula C₂₁H₂₆O₂, molecular weight 310.43 g/mol, and CAS number 72-33-3. The FDA Substance Registration System confirms the molecular formula, molecular weight, stereochemical configuration and chemical identity of Mestranol.
The systematic chemical name of Mestranol is (17α)-3-Methoxy-19-norpregna-1,3,5(10)-trien-20-yn-17-ol. It is a steroidal estrogen and a prodrug of ethinylestradiol. NCATS describes Mestranol as a biologically inactive prodrug that is converted to the estrogen agonist ethinylestradiol.
Mestranol has historically been used as an estrogenic component of oral contraceptive preparations. It was included in early combined oral contraceptive formulations, including the combination of mestranol and noretynodrel associated with the first FDA-approved oral contraceptive.
Mestranol is generally supplied as a white to practically white crystalline powder and is a highly potent steroidal pharmaceutical substance. Because of its potent pharmacological activity, handling, manufacturing and formulation should be performed under appropriate pharmaceutical quality and regulatory controls.
The current USP-NF monograph defines Mestranol as containing NLT 97.0% and NMT 102.0% of Mestranol, calculated on the dried basis. The USP monograph also lists Mestranol USP Reference Standard for official testing.
MEDIOCON INC supplies Mestranol API for qualified pharmaceutical customers with applicable Certificate of Analysis (COA), MSDS/SDS and technical specifications according to customer and batch requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to Practically White Crystalline Powder |
| Identification | IR & HPLC Complies |
| Assay (HPLC) | 97.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 153°C – 155°C |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Mestranol API Manufacturer & Supplier in India | MEDIOCON INC (CAS 72-33-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Mestranol API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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