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Pharmaceutical Chemistry
Tadalafil
Formula:
C22H19N3O4
GOST/CAS:
CAS 171596-29-5
Tadalafil (a highly effective selective inhibitor of phosphodiesterase type 5 (PDE-5)) is a specialized pharmaceutical component acting as a key Active Pharmaceutical Ingredient (API) for the manufacturing of medicinal products aimed at the treatment of erectile dysfunction and pulmonary arterial hypertension. The product is a crystalline powder, practically insoluble in water and sparingly soluble in alcohol. Due to its prolonged half-life (up to 36 hours), tadalafil is indispensable in modern pharmacology for developing long-acting medications with a high safety profile.
Applications
Manufacturing of ED Medications: Used as the primary active ingredient in the production of oral tablets (both standard and orally disintegrating). It ensures a prolonged therapeutic window (up to 36 hours), significantly improving the patient's quality of life.
Pulmonary Arterial Hypertension (PAH) Therapy: Applied in the manufacturing of drugs that reduce pressure in the pulmonary artery. It helps relax smooth muscles in blood vessels and increases physical exercise capacity.
Urological Practice (BPH): Included in the formulation of medications for treating the symptoms of benign prostatic hyperplasia. It helps reduce the severity of lower urinary tract symptoms.
Development of Combined APIs: Utilized in research and development activities to create next-generation combination drugs that merge PDE-5 inhibitors with other synergistic components.
Key Advantages
Prolonged Action: Features a unique therapeutic window (up to 36 hours) compared to other PDE-5 inhibitors, allowing outstanding flexibility in dosing the finished dosage form.
High Selectivity: Target-oriented action on PDE-5 with virtually no effect on PDE-6 (minimizing the risk of color vision distortion) or PDE-11, ensuring an excellent tolerability profile.
Manufacturing Stability: The crystalline structure of the substance is highly resistant to mechanical stress during direct compression, granulation, and tableting processes.
Pharmaceutical Purity: The product complies with strict international quality standards (USP/EP/BP), being completely free from foreign impurities and toxic residual solvents.
Storage & Transportation
- Store in dry, light-protected, and well-ventilated warehouse premises in tightly sealed original packaging, away from heat sources.
- Recommended temperature range: +15°C to +30°C (controlled room temperature).
- Avoid direct sunlight exposure and moisture (the substance is hygroscopic if the seal is compromised).
- Transportation is permitted by all types of covered transport while maintaining the required temperature conditions. The material is not classified as dangerous goods (UN Class 9 is absent). Shelf life — 3 years from the date of manufacture.
Technical Specifications
Appearance
White or almost white crystalline powder
Molecular Mass
389.41 g/mol
Assay (Active Substance Mass Fraction)
≥ 98.5% — 101.5% (on the dried basis)
Melting Point
298°C – 300°C
Loss on Drying
≤ 0.5%
Residual Solvents
Meets Purity requirements (within ICH guidelines)
Supply info
- Pharmaceutical double polyethylene bags packed inside plastic or fiber drums of 10 kg / 25 kg (standard packaging for APIs).
- Customized packaging in specialized containers is available for R&D laboratories (starting from 1 kg).
- Every batch is accompanied by a full documentation package: DMF (Type II Drug Master File), GMP Certificate, and COA (Certificate of Analysis).