Testosterone Enanthate is a long-acting ester derivative of testosterone and an important steroid hormone API used in pharmaceutical formulations. It is formed by esterification of the 17β-hydroxyl group of testosterone with enanthic acid, providing a depot form that is hydrolyzed in vivo to release testosterone.
Testosterone Enanthate has the molecular formula C₂₆H₄₀O₃ and a molecular weight of 400.59 g/mol. It is identified chemically as 3-oxoandrost-4-en-17β-yl heptanoate and is also known as testosterone heptanoate.
Testosterone Enanthate is a synthetic androgen ester of the naturally occurring hormone testosterone. Esterification increases the lipophilicity of testosterone and enables a prolonged-release profile following administration.
The API is generally supplied as a white to yellowish-white crystalline powder. Pharmacopoeial references describe it as practically insoluble in water, very soluble in anhydrous ethanol and freely soluble in fatty oils.
Testosterone Enanthate is an esterified form of testosterone in which the 17β-hydroxyl group is esterified with an enanthate/heptanoate chain. The ester structure contributes to slower release of testosterone after administration compared with unesterified testosterone.
FDA describes testosterone enanthate as an ester derivative of endogenous testosterone and gives its chemical name as (17β)-17-[(1-oxoheptyl)oxy]-androst-4-en-3-one.
The API has a steroidal four-ring structure and belongs to the androgen class of pharmaceutical substances.
Following administration, Testosterone Enanthate is hydrolyzed to testosterone. Testosterone and its active metabolites interact with androgen receptors in target tissues and regulate androgen-responsive gene expression.
The pharmacological effects of testosterone include support of male reproductive development and maintenance of androgen-dependent physiological functions. The exact clinical use and formulation depend on the approved pharmaceutical product and applicable regulatory requirements.
Testosterone Enanthate is used as an active pharmaceutical ingredient in testosterone replacement and androgen-containing pharmaceutical formulations.
Commercial pharmaceutical products containing testosterone enanthate are available in injectable dosage forms. FDA-approved products include testosterone enanthate injection formulations, including products administered by intramuscular or subcutaneous routes depending on the specific formulation.
The API is relevant to pharmaceutical development and manufacturing of products intended for clinically diagnosed testosterone deficiency and other approved androgen-replacement indications.
Testosterone Enanthate API quality is evaluated using pharmacopoeial and validated analytical methods.
Important quality-control parameters include:
The USP monograph specifies an assay/content range of 97.0–103.0%. USP also identifies IR and UV procedures, a melting range of 34–39°C, specific rotation testing and limits for free heptanoic acid and ordinary impurities.
Current BP/Ph. Eur. reference information specifies individual impurity controls, an unspecified impurity limit of 0.10% and a total impurity limit of 0.7%.
Swapnroop Drugs and Pharmaceuticals is a WHO-GMP certified pharmaceutical company in India engaged in pharmaceutical APIs and related pharmaceutical raw materials for domestic and international markets.
Testosterone Enanthate API can be manufactured and supplied according to applicable pharmacopoeial, customer-specific and regulatory specifications. Quality documentation and analytical information can be provided according to the requirements of the intended pharmaceutical application and destination market.
Testosterone Enanthate should be stored in well-closed containers and protected from light and excessive environmental exposure.
Pharmacopoeial references specify storage in tightly/well-closed containers. The International Pharmacopoeia recommends protection from light and storage at 2–8°C, while USP specifies well-closed containers and a cool storage condition. The final storage condition should follow the approved API specification and stability data for the particular material.
Technical documentation for Testosterone Enanthate API may include:
Swapnroop Drugs and Pharmaceuticals operates as a WHO-GMP certified pharmaceutical company with experience in pharmaceutical APIs and international markets.
For Testosterone Enanthate API requirements, customers can request product specifications, analytical documentation, packaging information and commercial details according to their pharmaceutical development, manufacturing and regulatory requirements.
Swapnroop Drugs and Pharmaceuticals
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–103.0% |
| Loss on Drying | NMT 0.5% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.7% |
| Specific Rotation | +77° to +83° at 20°C, dioxane solution |
| Melting Point | 34–39°C |