Ethinyl Estradiol API is a potent synthetic estrogen widely used in combination with hormonal therapies. As a key Active Pharmaceutical Ingredient (API), it plays a central role in oral contraceptive formulations and hormone replacement therapies.
Amber Lifesciences Pvt. Ltd., a GMP-certified manufacturer, offers high-purity Ethinyl Estradiol API for global pharmaceutical needs. Each batch is supported with complete documentation, including Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS), ensuring regulatory compliance and quality assurance.
What is Ethinyl Estradiol API?
Ethinyl Estradiol is a semisynthetic form of estradiol, developed to provide an extended half-life and improved oral bioavailability compared to naturally occurring estrogens. It is widely used for its strong estrogenic activity and its ability to regulate the hypothalamic-pituitary-gonadal axis.
Technical Specifications:
- CAS Number: 57-63-6
- Molecular Formula: C₂₀H₂₄O₂
- Molecular Weight: 296.4 g/mol
- Appearance: White to off-white crystalline powder
- Purity (HPLC): ≥ 98.0%
- Storage Conditions: Store at 2°C–8°C, protected from light and moisture
- Shelf Life: 36 months (when stored properly)
Applications of Ethinyl Estradiol API in Pharmaceutical Formulations
- Oral Contraceptive Tablets: Combined with progestins such as Levonorgestrel, Desogestrel, or Norethindrone to inhibit ovulation and regulate menstrual cycles.
- Hormone Replacement Therapy (HRT): Low-dose oral tablets, transdermal patches, and topical gels for managing estrogen deficiency in postmenopausal women.
- Dermatological Therapies: Used with anti-androgenic agents in oral treatments for acne, hirsutism, and PCOS.
- Multiple Dosage Forms: Suitable for coated tablets, transdermal systems, and topical applications.
- Controlled Dosing: Used in monophasic and multiphasic contraceptive products for optimized efficacy and reduced side effects.
Global Export Presence of Ethinyl Estradiol API
Amber Lifesciences exports Ethinyl Estradiol API to over 30 countries, including: Brazil, Germany, Japan, France, India, Mexico, Egypt, and Italy.
Our regulatory and logistics teams ensure smooth COA, DMF, and shipment processes.
Why Choose Amber Lifesciences Pvt. Ltd. for Ethinyl Estradiol API?
- GMP-certified manufacturing facility
- Stringent quality control and batch reproducibility
- Customizable packaging & bulk supply
- Trusted by pharmaceutical companies worldwide
- Competitive pricing with reliable global logistics
Conclusion
Ethinyl Estradiol is a critical component in hormonal therapies, and sourcing it from a reliable GMP-certified API manufacturer is essential for safety and regulatory compliance. Amber Lifesciences Pvt. Ltd. delivers consistent quality, regulatory support, and global reach.