Ethinyl Estradiol
CAS No.: 57-63-6
Synonym: Estinyl
Mol. Formula: C₂₀H₂₄O₂
Mol. Weight: 296.40 g/mol
ATC Code: G03CA01, L02AA03
Therapeutic Category: Hormonal, Steroidal
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality:
Ethinyl Estradiol API, a synthetic estrogen widely used in contraceptives and hormone therapy, is manufactured under strict GMP and ISO 9001:2015 standards. Each batch undergoes rigorous analytical testing for purity, potency, and impurity profiling to meet global pharmacopeial standards, ensuring consistent quality, stability, and therapeutic efficacy.

2) Comprehensive Documentation:
Amber Lifesciences provides detailed regulatory documentation for Ethinyl Estradiol API, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), stability reports, and CTD/ACTD dossiers. This comprehensive documentation facilitates regulatory compliance and supports smooth product registration across global markets.

3) Secure Supply Chain:
A robust and traceable supply chain ensures uninterrupted availability of Ethinyl Estradiol API. Amber Lifesciences maintains temperature-controlled storage, validated packaging, and strict quality monitoring at every stage of logistics, safeguarding product integrity from manufacturing to delivery.

4) Manufacturer & Supplier Expertise:
Amber Lifesciences leverages extensive expertise in steroid synthesis, process optimization, and analytical validation to deliver reproducible large-scale production. Their R&D and quality assurance teams maintain the highest standards, ensuring global regulatory compliance and consistent API quality.

5) Amber Lifesciences’ Role:
Amber Lifesciences Pvt. Ltd. is a leading global manufacturer and supplier of Ethinyl Estradiol API. Their focus on superior quality, comprehensive documentation, and secure supply chain solutions positions them as a trusted partner for pharmaceutical companies worldwide seeking GMP-certified, high-quality estrogen APIs.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.