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FIEO
Solifenacin Succinate is a selective muscarinic M3 receptor antagonist widely used in the treatment of overactive bladder (OAB) with symptoms of urgency, frequency, and urge incontinence. By selectively inhibiting M3 receptors in the bladder smooth muscle, it reduces involuntary contractions, improving urinary control and patient quality of life.
Bluepill Express offers high-purity Solifenacin Succinate API, manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API is compliant with global pharmacopoeial standards (IP, BP, USP, EP) and is suitable for the development of tablets and oral solid dosage forms for international markets.
Therapeutic Uses
- Management of overactive bladder (OAB)
- Treatment of urinary urgency, frequency, and urge incontinence
- Used in chronic urinary disorders to improve patient quality of life
Mechanism of Action
Solifenacin selectively blocks M3 muscarinic receptors in bladder detrusor muscles, inhibiting acetylcholine-mediated smooth muscle contractions. This action reduces bladder overactivity, decreases urinary frequency, and alleviates episodes of urgency and incontinence. Its high selectivity for M3 receptors minimizes systemic anticholinergic side effects compared to non-selective agents.
Pharmacological Information
- Chemical Name: (1S)-1-phenyl-1-azabicyclo[2.2.2]octan-3-yl-(3R)-3-hydroxy-1-phenylpropyl succinate
- Molecular Formula: C44H66N2O12
- Molecular Weight: 666.02 g/mol
- CAS Number: 106578-79-6
- Therapeutic Class: Antimuscarinic / Urinary Bladder Relaxant
- Pharmacological Class: M3 Muscarinic Receptor Antagonist
- ATC Code: G04BD08
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in methanol, ethanol; slightly soluble in water |
| Melting Point | 140°C – 145°C (decomposition) |
| pH (1% aqueous solution) | 4.5 – 6.0 |
| Storage | Store below 25°C in a dry, well-ventilated area, protected from light |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.3% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Solifenacin Succinate API is primarily used in:
- Immediate-release tablets
- Extended-release tablet formulations
- Combination therapies for urinary disorders
The API is compatible with direct compression and wet granulation processes, ensuring consistent formulation quality.
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Pack Sizes: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
