Amber Lifesciences Pvt. Ltd. is a GMP, ISO-certified, and USFDA-compliant manufacturer and global exporter of Estradiol Cypionate API. This long-acting ester of estradiol is widely used by pharmaceutical companies in extended-release hormone formulations, owing to its pharmacological stability and high purity profile.
Estradiol Cypionate API Chemical Profile
- 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] 3-cyclopentylpropanoate
- Molecular Formula: C₂₆H₃₆O₃
- Molecular Weight: 396.57 g/mol
- CAS Number: 313-06-4
- Appearance: White to almost white crystalline powder
This compound is produced under controlled GMP conditions, ensuring consistency across all batches.
Estradiol Cypionate API Pharmacological Classification
- API Type: Steroidal estrogen analog
- Category: Hormonal Active Pharmaceutical Ingredient (API)
- Primary Applications:
- Hormone Replacement Therapy (HRT)
- Estrogen-deficiency support
- Regulated hormone formulations
Estradiol Cypionate API Solubility & Storage
- Solubility:
- Slightly soluble in water
- Soluble in ethanol, DMSO, sesame oil, and other organic solvents
- Storage Conditions:
- Store between 2°C to 8°C
- Protect from light and moisture
- Use airtight containers to preserve potency and prevent oxidation
Estradiol Cypionate API – Pharmaceutical Applications & Formulation Insights
While Amber Lifesciences supplies Estradiol Cypionate strictly as an API, it is typically incorporated into:
- Oil-based injectable formulations
- Combination therapies with other hormonal APIs for regulated therapeutic use
Note: Supplied for pharmaceutical manufacturing purposes only.
Estradiol Cypionate API Regulatory Compliance & Quality Assurance
Amber Lifesciences ensures global regulatory readiness with:
- Compliance with USP/NF, EP, and ICH guidelines
- Documentation includes Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), and DMF on request
- Manufactured in facilities audited for GMP standards
Estradiol Cypionate API Analytical & Quality Control Methods
- HPLC/UV: Potency and purity assay (USP/EP compliant)
- IR Spectroscopy: Confirms compound identity
- Residual Solvent Analysis: As per ICH Q3C standards
- Impurity Profiling: Follows pharmacopeial monographs
Each batch undergoes comprehensive QC testing before shipment.
Estradiol Cypionate API Global Supply Capabilities
Amber Lifesciences is a trusted API supplier for pharmaceutical companies in:
- LATAM
- EU
- MENA
- Asia-Pacific
We offer flexible MOQs, reliable lead times, and full regulatory support for our international partners.
Why Choose Amber Lifesciences for Estradiol Cypionate API?
- GMP and ISO certifications
- Full regulatory documentation: CoA, MSDS, DMF
- Consistent batch-to-batch purity and traceability
- Reliable global shipping & export logistics
- Dedicated technical and regulatory support team
Conclusion
Estradiol Cypionate API is a high-value, long-acting estrogen ester used in regulated hormone formulations globally. Known for its stability and extended release, it plays a vital role in HRT and estrogen therapies.
Amber Lifesciences Pvt. Ltd. is a trusted manufacturer and exporter of Estradiol Cypionate API — delivering precision manufacturing, compliance support, and global reach to pharmaceutical companies worldwide.