Active Pharmaceutical Ingredient

Ethinyl Estradiol

Also known as: EE; 17α-Ethinylestradiol; Ethinyloestradiol

CAS: 57-63-6 Synthetic Estrogen IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Ethinyl Estradiol API — Mediocon Inc
Ethinyl Estradiol — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 57-63-6  |  MF: C₂₀H₂₄O₂  |  MW: 296.40 g/mol

Ethinyl Estradiol is a high-purity Synthetic Estrogen supplied by Mediocon Inc as an Active Pharmaceutical Ingredient (API) conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India, it meets the stringent quality requirements of global pharmaceutical manufacturers.

Ethinyl Estradiol is a potent synthetic estrogen widely used as the estrogenic component in combined oral contraceptive pills. It is also used in hormone replacement therapy and treatment of certain hormone-dependent conditions.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Combined oral contraceptive pills
  • Hormone replacement therapy
  • Treatment of hypogonadism
  • Palliative treatment of prostate and breast cancer

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameEthinyl Estradiol
Also Known AsEE; 17α-Ethinylestradiol; Ethinyloestradiol
CAS Number57-63-6
Molecular FormulaC₂₀H₂₄O₂
Molecular Weight296.40 g/mol
CategorySynthetic Estrogen
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; soluble in ethanol, chloroform
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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