Amber Lifesciences Pvt. Ltd. is a leading estrogen API manufacturer and global exporter of Estradiol Valerate API, produced under GMP and internationally recognized quality standards. Known for its pharmaceutical-grade purity and comprehensive documentation (COA, MSDS, DMF), our API is trusted by pharmaceutical companies across LATAM, MENA, Europe, and Asia.
Chemical Profile of Estradiol Valerate API
IUPAC Name: [(8R,9S,13S,14S,17S)-3-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] pentanoate
CAS Number: 979-32-8
Molecular Formula: C₂₃H₃₂O₃
Molecular Weight: 356.50 g/mol
Appearance: White to off-white crystalline powder
Estradiol Valerate API – Key Pharmaceutical Applications
- Hormone Therapy APIs – Used in the production of formulations for managing menopause symptoms and preventing postmenopausal osteoporosis.
- Combination Contraceptive APIs – Used in contraceptive formulations for cycle regulation.
Pharmacokinetic Properties (API Reference Data)
- Absorption: Suitable for oral and intramuscular (IM) formulation manufacturing.
- Metabolism: Hydrolyzed in vivo to estradiol and valeric acid.
- Half-life: Oral: 12–20 hours; IM: depot release (days to weeks).
- Excretion: Renal elimination as conjugated metabolites.
Estradiol Valerate API Manufacturing & Quality Standards
- Synthesis Method: Produced via esterification of high-purity 17β-estradiol with valeric acid or valeroyl chloride under validated GMP conditions.
- Compendial Compliance: Conforms to pharmacopeial standards (USP/EP/JP).
- Storage Guidelines: Store at 2–8°C, protected from light and moisture.
- Solubility: Soluble in ethanol, DMSO, and oil-based systems; practically insoluble in water.
Estradiol Valerate API Possible Formulation Uses (API Supply Only)
- Oral Tablets
- Intramuscular Depot Injections
- Transdermal Systems
- Topical Gels (market-specific)
Estradiol Valerate API Global Availability
Amber Lifesciences Pvt. Ltd. exports Estradiol Valerate API to over 20 countries, including Brazil, Australia, Latvia, Singapore, Paraguay, and Mexico.
We provide comprehensive API regulatory support – including COA, MSDS, and DMF – tailored to meet each market’s specific requirements.
Why Partner with Amber Lifesciences for Estradiol Valerate API?
- GMP and ISO-compliant API manufacturing
- Consistent batch-to-batch quality
- Complete COA, MSDS, and DMF documentation
- Competitive pricing and reliable supply chain
- Proven export track record across LATAM, MENA, Europe, and Asia
Conclusion
Estradiol Valerate API is an essential raw material for estrogen-based and hormone therapy formulations. Its stability, extended-release profile, and pharmacopeial compliance make it a preferred choice for global manufacturers. Amber Lifesciences Pvt. Ltd. ensures GMP-compliant production, complete regulatory documentation, and dependable international delivery for your API sourcing needs.
