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Specifications of Tadalafil丨CAS 171596-29-5
|
Property |
Specification |
|
Grade |
EP11.0 |
|
Appearance |
White or almost white powder |
|
Assay |
97.5% and 102.5%, calculated on the dried basis |
|
Solubility |
Freely soluble in dimethyl sulfoxide, slightly soluble in dichloromethane, practically insoluble in water |
|
Specific Optical Rotation |
78.0° - 84.0° |
|
HPLC |
The retention time of the major peak of the Sample solution corresponds to that of the Identification solution, as obtained in the test for Enantiomeric and Diastereomeric Purity |
|
Organic Impurities |
|
|
Individual Impurities |
0.1% max |
|
Total Impurities |
0.3% max |
|
Enantiomeric |
|
|
6R,12aS Diastereomer |
0.1% max |
|
6S,12aS Enantiomer |
0.1% max |
|
6S,12aR Diastereomer |
0.1% max |
|
Residual Solvents |
|
|
Methylamine |
0.163% max |
|
Methanol |
0.3% max |
|
Acetonitrile |
0.041% max |
|
Isopropanol |
0.5% max |
|
Ethyl Acetate |
0.5% max |
|
DMF |
0.088% max |
|
Residue on Ignition |
0.1% max |
|
Loss on Drying |
0.5% max |
Tadalafil丨CAS 171596-29-5, is a phosphodiesterase type 5 (PDE5) inhibitor used primarily for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Tadalafil works by inhibiting the PDE5 enzyme, which regulates blood flow in the penis and prostate, thereby improving symptoms of ED and BPH. It was first approved by the U.S. FDA in 2003 and has since become a widely prescribed medication for erectile dysfunction.
Applications of Tadalafil丨CAS 171596-29-5
1. Erectile Dysfunction (ED)
● Cialis is primarily used to treat erectile dysfunction (ED), a condition where a man cannot achieve or maintain an erection sufficient for sexual activity.
● It works by increasing blood flow to the penis through the inhibition of PDE5, a protein that regulates blood flow by breaking down cyclic guanosine monophosphate (cGMP). This allows for prolonged vasodilation and an erection in response to sexual stimulation.
● Long Duration of Action: One of the significant benefits of Cialis over other PDE5 inhibitors (like Viagra) is its long half-life of approximately 17.5 hours, allowing for effects that can last up to 36 hours. This allows for more spontaneous sexual activity.
2. Benign Prostatic Hyperplasia (BPH)
● Tadalafil is also used to treat benign prostatic hyperplasia (BPH), a condition characterized by an enlarged prostate, which can lead to urinary difficulties, such as frequent urination, urgency, and weak urine flow.
● By inhibiting PDE5, Cialis relaxes the smooth muscles in the prostate and bladder, which helps reduce the symptoms of BPH and improve urinary flow.
3. Pulmonary Arterial Hypertension (PAH)
● Tadalafil is approved for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the lungs' arteries.
● It works by relaxing the blood vessels in the lungs, lowering pulmonary arterial pressure, and improving exercise capacity in patients with PAH.
● Cialis is often prescribed under a different brand name for PAH treatment (Adcirca).
4. Off-Label Uses
● Raynaud's Disease: Cialis has been explored for use in treating Raynaud's phenomenon, where blood vessels in the extremities constrict in response to cold or stress.
● Diabetic Neuropathy: Some studies suggest that tadalafil may have a potential role in managing diabetic neuropathy, although this is still under investigation.
Benefits of Tadalafil丨CAS 171596-29-5
1. Effective Treatment for ED
● Cialis is known for its rapid onset of action (typically within 30 minutes), and its long duration of effect, providing a window of opportunity for up to 36 hours of effectiveness.
● Unlike other erectile dysfunction medications, Cialis does not require precise timing before sexual activity, making it more convenient for spontaneous use.
2. Improved Quality of Life
● Beyond physical benefits, tadalafil has been shown to improve the psychological well-being of individuals with erectile dysfunction by boosting confidence and reducing anxiety related to performance.
● By treating BPH, it improves the quality of life in men suffering from lower urinary tract symptoms (LUTS), leading to better urinary function and fewer interruptions to daily activities.
3. Dual Action for ED and BPH
● The ability to treat both erectile dysfunction and benign prostatic hyperplasia in a single medication is a significant benefit for men who suffer from both conditions.
● Tadalafil can help men manage both sexual health and urinary symptoms, leading to improved overall health and comfort.
4. Safety Profile
● Tadalafil丨CAS 171596-29-5 is generally well-tolerated, with a relatively mild side effect profile compared to other medications for erectile dysfunction.
● The long half-life means patients typically need to take fewer doses, and daily dosing options allow for continuous benefits for men with frequent ED or BPH symptoms.
Conclusion
Tadalafil丨CAS 171596-29-5 is a highly effective medication for the treatment of erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. Its long duration of action (up to 36 hours) makes it more convenient compared to other erectile dysfunction medications. It has the added benefit of treating both sexual dysfunction and urinary symptoms in men with BPH, improving overall quality of life. While generally safe, it should be used under medical supervision, especially in individuals with certain medical conditions.
