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Mebeverine Hydrochloride is a direct-acting antispasmodic agent widely used for the management of irritable bowel syndrome (IBS) and other gastrointestinal spastic disorders. It works by relaxing smooth muscles in the gastrointestinal tract without affecting normal gut motility, providing relief from abdominal pain, cramps, and bloating.
Bluepill Express manufactures high-purity Mebeverine HCl API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with IP, BP, USP, and EP standards. The API is suitable for tablet, capsule, and oral formulation development, catering to both domestic and international pharmaceutical markets.
Therapeutic Uses
- Irritable Bowel Syndrome (IBS): Relieves abdominal pain and discomfort
- Gastrointestinal Spasms: Reduces cramps and bloating
- Functional GI Disorders: Supports normal digestive motility
- Combination Therapy: Used with other antacids or digestive formulations
- Pediatric and adult formulations
Mechanism of Action
Mebeverine HCl acts by directly relaxing smooth muscles of the gastrointestinal tract:
- Reduces spastic contractions of the gut
- Alleviates abdominal pain and cramps
- Does not affect normal peristalsis, maintaining healthy bowel function
- Minimizes discomfort associated with functional bowel disorders
Pharmacological Information
- Chemical Name: (2S,3S,4S,5S)-2-(2,2-Dimethylpropylamino)-3,4,5-trimethoxybenzyl alcohol hydrochloride
- Molecular Formula: C22H33NO4·HCl
- Molecular Weight: 403.96 g/mol
- CAS Number: 150-86-7
- Therapeutic Class: Antispasmodic
- Pharmacological Class: Smooth Muscle Relaxant / GI Antispasmodic
- ATC Code: A03AA05
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in water and ethanol; slightly soluble in chloroform |
| Melting Point | 160°C – 164°C |
| pH (1% aqueous solution) | 5.5 – 7.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
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 | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Mebeverine HCl API is used in:
- Tablet and capsule formulations for IBS and GI disorders
- Oral suspensions and powders
- Combination GI therapy formulations
- Pharmaceutical bulk production for domestic and international markets
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 Packs: 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
