English 
Español 
français 
العربية Search
Search
Darifenacin hydrobromide, an orally active, once a day selective M3 receptor antagonist, was launched for the treatment of overactive bladder in patients with symptoms of urge urinary incontinence, urgency and frequency. The drug selectively inhibits M3 receptor in the detrusor muscle while sparing the M1 and M2 receptors that are believed to be involved in central nervous system and cardiovascular function respectively.
Darifenacin hydrobromide is used to treat bladder hyperactivity with symptoms of acute urinary incontinence, urgency, and urinary frequency.
Items | Specifications | Results |
Appearance | White crystalline powder | |
Identification | B:HPLC | Conforms |
Specific Rotation(1% solution in methylene chloride) | +42°~ +47° | +46.44° |
Related Substances(By HPLC) | Individual impurity:NMT 0.5% Total impurities:NMT 1.0% | 0.063% 0.21% |
Optical isomer | Not more than 0.5% | ND |
Residual solvents | Ethyl Acetate:NMT 0.5% Ethanol:NMT 0.5% Methanol:NMT 0.3% Acetone:NMT 0.5% 1-Butanol:NMT 0.5% | ND 0.10% 0.029% ND ND |
Loss on drying (at 105℃ till a constant weight) | Not more than 1.0% | 0.07% |
Residue on Ignition | 0.03% | |
Heavy Metals | Not more than 20ppm | Conforms |
Assay(on dried basis,by titration) | Not less than 98.5% | 99.81% |
Conclusion | The product conforms to the above specifications. | |
| Product parameters | |
| Cas number: | 133099-07-7 |
| Appearance: | White to off-white powder |
| Purity: | 99%min |
| Package details: | 10g/bottle; 100g/foil bag |
| Brand: | Fortunachem |
Mechanism of Action: Targets muscarinic M3 receptors in the bladder detrusor muscle. Blocking these receptors relaxes the muscle, decreasing urinary frequency, urgency, and urge incontinence (uncontrolled leakage).
Indications: Specifically approved for OAB symptoms, including frequent urination (≥8 times daily), sudden strong urges to urinate, and urge-related leakage.
Formulation: Available as extended-release tablets (once-daily dosing), designed to release the drug gradually for sustained effect.
Contraindications: Not for use in people with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or severe liver impairment.
Common Side Effects: Dry mouth, constipation, dry eyes, and blurred vision (typical of anticholinergics). Less common effects include urinary hesitation, abdominal pain, and dizziness.
Precautions: Use cautiously in those with liver/kidney impairment, gastrointestinal disorders (e.g., irritable bowel syndrome), or cognitive issues (may worsen confusion in older adults). Avoid alcohol and other anticholinergic drugs to reduce side effect risk.
Drug Interactions: May interact with potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) or inducers (e.g., rifampin), requiring dosage adjustments.
It is a prescription-only medication, so it must be used under a healthcare provider’s supervision.
Dosage is typically started low and adjusted based on tolerance and symptom improvement.
It may take 2–4 weeks to experience full therapeutic benefits.
Used as a medication to treat urinary incontinence.
Fortunachem Provides Not Only Professional Chemical Products But Also Professional Help
Keeping you up-to-date with all the latest information, news, and events about Fortunachem!
Quick Links
Add:
E-mail:
