Testosterone Undecanoate API is a long-chain fatty-acid ester of testosterone and belongs to the androgen class of pharmaceutical active ingredients. It is designed to provide testosterone replacement through conversion of the ester to active testosterone in the body.
Testosterone Undecanoate is used as an active pharmaceutical ingredient in formulations developed for testosterone replacement therapy in adult males with testosterone deficiency or hypogonadal conditions. The API is available in pharmaceutical formulations including oral and intramuscular dosage forms.
As a testosterone ester, Testosterone Undecanoate contains an undecanoate group attached to testosterone at the 17β position. Following administration, the ester is cleaved to release testosterone, which is responsible for the principal androgenic activity.
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Testosterone Undecanoate is a steroid ester and androgenic API. Its chemical structure combines the testosterone steroid nucleus with an undecanoate fatty-acid ester group.
The identity, formula, molecular weight and CAS number are supported by PubChem, while FDA labeling describes Testosterone Undecanoate as a white to off-white crystalline substance.
Testosterone Undecanoate is chemically an ester of testosterone and undecanoic acid. Esterification modifies the physicochemical and pharmacokinetic characteristics of testosterone and enables its use in longer-acting testosterone replacement formulations.
Chemical Name: Testosterone Undecanoate
Molecular Formula: C₃₀H₄₈O₃
Molecular Weight: 456.7 g/mol
CAS: 5949-44-0
IUPAC Name: [(8R,9S,10R,13S,14S,17S)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] undecanoate.
Testosterone Undecanoate is structurally related to other testosterone esters such as testosterone cypionate and testosterone enanthate, but it should be treated as a separate API with its own identity and quality specifications.
Testosterone Undecanoate functions as a prodrug/ester of testosterone. After administration, the undecanoate ester undergoes enzymatic cleavage, producing testosterone.
Testosterone subsequently interacts with androgen receptors and contributes to normal development and maintenance of male reproductive organs, secondary sexual characteristics, muscle mass and other androgen-dependent physiological functions. Testosterone may also be converted to dihydrotestosterone (DHT) and estradiol, which contribute to different physiological effects.
Testosterone Undecanoate API is used in the development and manufacture of pharmaceutical formulations intended for testosterone replacement.
Major pharmaceutical applications include:
FDA labeling identifies testosterone undecanoate products for testosterone replacement therapy in adult males with testosterone deficiency or hypogonadal conditions.
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| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |