Testosterone Propionate is a synthetic ester of testosterone and an important steroid hormone API belonging to the androgen class. It is the propionate ester of testosterone and has a shorter-release profile than longer-chain testosterone esters.
Testosterone Propionate has the molecular formula C₂₂H₃₂O₃ and a molecular weight of 344.49 g/mol. Its CAS number is 57-85-2. It occurs as white to pale yellow crystals or crystalline powder and is practically insoluble in water.
Testosterone Propionate is produced by esterification of the 17β-hydroxyl group of testosterone with propionic acid. The esterification modifies the physicochemical and pharmacokinetic characteristics of testosterone.
The API is characterized by established analytical techniques including infrared spectroscopy, ultraviolet spectroscopy, chromatographic purity testing, assay, specific rotation, melting range and loss-on-drying determination.
Testosterone Propionate is a 17β-propionate ester of testosterone. Its steroid nucleus is structurally related to endogenous testosterone, while the propionate ester influences its release characteristics after administration.
The compound is described pharmacopoeially as 3-oxoandrost-4-en-17β-yl propionate. It is freely soluble in methanol and ethanol and practically insoluble in water.
Following administration, Testosterone Propionate is hydrolyzed to testosterone. Testosterone subsequently interacts with androgen receptors in target tissues and influences androgen-responsive gene expression.
The resulting androgenic and anabolic effects depend on the pharmaceutical formulation, dose and approved clinical application.
Testosterone Propionate has historically been used as an active pharmaceutical ingredient in androgen and testosterone-containing pharmaceutical formulations.
Its pharmaceutical applications are associated with testosterone replacement and androgen therapy in approved formulations. The exact indication, route of administration and dosage depend on the finished pharmaceutical product and applicable regulatory authorization.
Testosterone Propionate is also used as a reference and development material in pharmaceutical research involving steroid hormones and androgenic compounds.
Testosterone Propionate API quality can be evaluated using pharmacopoeial and validated analytical procedures, including:
The USP monograph specifies an assay range of 97.0–103.0% calculated on the dried basis, a melting range of 118–123°C, specific rotation of +83° to +90°, and loss on drying of not more than 0.5%.
BP reference information specifies related-substance controls including an unspecified impurity limit of 0.10% and total impurities of 0.7%.
Swapnroop Drugs and Pharmaceuticals is a WHO-GMP certified pharmaceutical company in India engaged in pharmaceutical APIs and pharmaceutical raw materials for domestic and international markets.
Testosterone Propionate API can be evaluated against applicable pharmacopoeial requirements, customer-specific specifications and regulatory requirements. Technical documentation and analytical information can be provided according to the intended pharmaceutical application and destination market.
Testosterone Propionate should be protected from excessive light, moisture and unsuitable environmental conditions.
USP specifies preservation in well-closed, light-resistant containers. JP also specifies light-resistant storage. The final storage conditions should follow the approved API specification and stability data for the particular batch.
Typical technical documentation for Testosterone Propionate API may include:
Swapnroop Drugs and Pharmaceuticals operates as a WHO-GMP certified pharmaceutical company with a portfolio of pharmaceutical APIs and pharmaceutical raw materials.
For Testosterone Propionate API requirements, customers can request product specifications, analytical documentation, packaging information and commercial details according to their pharmaceutical development, manufacturing and regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–103.0% on dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.7% |
| Specific Rotation | +83° to +90° |
| Melting Point | 118–123°C |