Buy Testosterone Enanthate API from Amber Lifesciences Pvt. Ltd. to regulated and semi-regulated markets worldwide, ensuring pharmaceutical-grade quality for injectable formulations. Produced in GMP and ISO-certified facilities, our API is backed by complete analytical documentation, DMF support, and reliable global logistics for seamless market integration.
Testosterone Enanthate API Specifications Snapshot
- CAS: 315-37-7
- Molecular Formula: C₂₆H₄₀O₃
- Molecular Weight: 400.6 g/mol
- IUPAC Name: [(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-yl] heptanoate
- Appearance: White to off-white crystalline powder
- Solubility: Soluble in organic solvents; practically insoluble in water
Testosterone Enanthate API Therapeutic & Formulation Uses
Testosterone Enanthate is a long-acting testosterone ester used in injectable formulations for testosterone replacement therapy (TRT). It helps restore optimal testosterone levels, support muscle mass, improve bone density, and enhance overall vitality in patients with testosterone deficiency. Its slow-release profile makes it ideal for sustained intramuscular delivery, reducing dosing frequency.
Testosterone Enanthate API Manufacturing & Quality Assurance
Manufactured under strict GMP controls, every batch meets USP/EP/BP standards. Our quality program includes:
- HPLC/GC assay & impurity profiling
- Residual solvent analysis
- Identity confirmation via IR/UV
- Microbial limit testing
- Validated methods with reference standards and trend data to ensure batch-to-batch consistency
Testosterone Enanthate API Documentation & Regulatory Support
- CoA & MSDS with every shipment
- DMF & technical package support on request
- Stability studies per ICH Q1A(R2) for global climatic zones II–IVb
- Full traceability and change control systems in line with regulatory expectations
Testosterone Enanthate API Packaging, Storage & Handling
- Packaging: Double-lined, tamper-evident bags in HDPE/fiber drums
- Storage: Store in a cool, dry place away from light (15–30°C)
- Handling: Use in controlled environments under cGMP guidelines
Global Supply & Logistics
Amber Lifesciences supports bulk shipments across LATAM, MENA, Europe, and Asia-Pacific with flexible MOQ, optimized lead times, and reliable EXW/FOB/CIF delivery terms.
Why Partner with Amber Lifesciences
- GMP & ISO 9001:2015-certified manufacturing with robust in-process controls
- Full pharmacopeial compliance and advanced impurity control
- Ready regulatory documentation for smooth submissions
- Predictable supply chain with dedicated customer support
Conclusion
Testosterone Enanthate API is a vital component in hormone replacement therapies and other testosterone-based treatments, offering long-lasting and reliable results. By partnering with Amber Lifesciences Pvt. Ltd., pharmaceutical companies gain access to a pure, compliant, and globally trusted API that meets both therapeutic needs and regulatory standards.