Swapnroop is a pharmaceutical API manufacturer in India offering Testosterone Cypionate API for pharmaceutical manufacturing applications. Testosterone Cypionate is a synthetic ester of testosterone belonging to the androgen and anabolic steroid class. It is an oil-soluble, long-acting testosterone ester used in pharmaceutical preparations for testosterone replacement therapy.
Testosterone Cypionate has the molecular formula C₂₇H₄₀O₃, molecular weight 412.61 g/mol, and CAS No. 58-20-8. FDA and NIST records identify the substance as the 17β-cyclopentylpropionate ester of testosterone.
Testosterone Cypionate is a synthetic derivative of the naturally occurring androgen testosterone. The cypionate ester increases the lipophilicity of testosterone and provides a longer duration of release following intramuscular administration.
The API is supplied as a pharmaceutical active ingredient for the manufacture of approved testosterone-containing medicinal products. FDA labeling describes Testosterone Cypionate as a white or creamy-white crystalline powder that is insoluble in water and soluble in several organic solvents and vegetable oils.
Product Name: Testosterone Cypionate
CAS No.: 58-20-8
Molecular Formula: C₂₇H₄₀O₃
Molecular Weight: 412.61 g/mol
Chemical Class: Testosterone Ester
Therapeutic Category: Androgen
Drug Class: Androgen / Anabolic Steroid
Active Moiety: Testosterone
Pharmaceutical Form: API for injectable pharmaceutical formulations
USP identifies Testosterone Cypionate as Androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)- and specifies a molecular weight of 412.60.
Testosterone Cypionate API is used in the manufacture of pharmaceutical testosterone replacement products. Approved testosterone cypionate injections are administered intramuscularly.
Pharmaceutical applications include:
The precise indication, dosage, route of administration and formulation are determined by the applicable approved medicinal product and regulatory requirements.
Testosterone is an endogenous androgen responsible for normal development and maintenance of male reproductive tissues and secondary sex characteristics. Testosterone Cypionate acts as a prodrug-like esterified form of testosterone that is gradually hydrolyzed to testosterone following administration.
Testosterone subsequently binds to androgen receptors and influences gene expression involved in androgen-dependent physiological processes. FDA labeling describes the androgenic effects of testosterone on reproductive organs, secondary sexual characteristics, body composition and other physiological functions.
Testosterone Cypionate is an important steroidal pharmaceutical API requiring appropriate control of chemical identity, assay, related substances, residual solvents, water content and other applicable quality characteristics.
Because the material is a steroid ester, chromatographic testing is particularly important for confirming purity and controlling related substances.
Typical quality-control testing for Testosterone Cypionate API may include:
USP provides a specific Testosterone Cypionate monograph and states an assay requirement of 97.0% to 103.0%, calculated on the dried basis.
Swapnroop focuses on pharmaceutical API manufacturing in India with an emphasis on quality control, analytical testing, manufacturing consistency and appropriate documentation.
Testosterone Cypionate manufacturing requires controlled process conditions, suitable raw-material management, purification, impurity control and validated analytical procedures. Swapnroop supports qualified pharmaceutical customers requiring Testosterone Cypionate API for pharmaceutical manufacturing applications.
Testosterone Cypionate API should be packed in suitable pharmaceutical-grade packaging that protects the material from moisture, contamination and environmental exposure.
The API should be stored according to the applicable approved specification and validated stability conditions. Packaging should remain properly sealed during storage and handling.
Depending on customer and regulatory requirements, documentation for Testosterone Cypionate API may include:
| 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% |
| Residue on Ignition | NMT 0.2% |
| Specific Rotation | +85° to +92° |
| Melting Point | 98–104°C |