Estradiol Valerate is a pharmaceutical-grade active pharmaceutical ingredient (API) widely supplied for hormone therapy (HRT) and treatments for estrogen deficiency-related conditions. This estrogen ester is essential in women’s health and certain palliative cancer therapies.
Amber Lifesciences supplies Estradiol Valerate API to regulated and semi-regulated markets across the globe, serving countries such as Brazil, Germany, Japan, and France.
Estradiol Valerate API – Key Information
Chemical Name: Estra-1,3,5(10)-triene-3,17-diol (17β)-, 17-pentanoate
Molecular Formula: C₂₃H₃₂O₃
CAS Number: 979-32-8
Appearance: White or almost white crystalline powder
Solubility: Soluble in ethanol, DMSO, and other organic solvents; insoluble in water
Estradiol Valerate API Manufacturing Process & Quality Compliance Standards
- Produced under strict GMP (Good Manufacturing Practices) protocols
- Compliant with USP, EP, BP, and JP pharmacopoeial standards
- Quality control includes impurity profiling, residual solvent analysis, and particle size distribution
- Supplied with complete documentation: CoA (Certificate of Analysis) and MSDS (Material Safety Data Sheet)
End-Use Applications of Estradiol Valerate API in Pharmaceutical Formulations
The following finished dosage forms are examples of how pharmaceutical manufacturers use Estradiol Valerate API:
- Oil-based intramuscular injections
- Oral tablets, often combined with progestins in contraceptive or HRT products
- Transdermal delivery systems for continuous hormone release
Regulatory Compliance & Storage Guidelines for Estradiol Valerate API
- Subject to hormonal substance regulations and API import/export controls in regulated markets
- Storage Conditions: 2°C to 8°C; protect from light and moisture
- Export documentation prepared in accordance with LATAM, EU, and Asia-Pacific market requirements
Why Choose Amber Lifesciences Pvt. Ltd. for Estradiol Valerate API?
- GMP and ISO-compliant manufacturing facilities
- Complete regulatory documentation support (CoA, MSDS)
- Reliable global supply with consistent quality and long-term stability
- Export-ready logistics solutions tailored for LATAM, EU, and other global markets
- Experienced R&D and quality assurance teams ensuring high-purity API production
Conclusion
Estradiol Valerate API plays a vital role in global hormone therapy manufacturing, particularly for menopause management, hypogonadism, and hormone-responsive conditions. With growing demand in regulated markets, pharmaceutical buyers prioritize API quality, documentation, and supply reliability.
Amber Lifesciences Pvt. Ltd. delivers high-purity Estradiol Valerate API with full GMP compliance, regulatory support, and dependable export capabilities—making it a trusted partner for global pharmaceutical companies.