Mebeverine Hydrochloride (Mebeverine HCl) is a synthetic antispasmodic pharmaceutical ingredient used primarily for the symptomatic treatment of gastrointestinal smooth-muscle spasms. It acts directly on intestinal smooth muscle and helps reduce abdominal cramping and spasmodic pain without significantly affecting normal intestinal motility.
Mebeverine HCl is widely used in pharmaceutical formulations intended for irritable bowel syndrome (IBS) and other conditions associated with gastrointestinal spasms.
Mebeverine HCl is an important gastrointestinal pharmaceutical API used in the development and manufacture of oral antispasmodic formulations.
Key quality attributes include identity, assay, related substances, water content, residual solvents, residue on ignition, elemental impurities and stability characteristics.
CAS Number: 2753-45-9
Molecular Formula: C25H36ClNO5
Molecular Weight: 466.01 g/mol
Chemical Name: Mebeverine Hydrochloride
Synonyms: Mebeverine HCl, Mebeverine Hydrochloride
Drug Class: Antispasmodic
Therapeutic Class: Gastrointestinal Antispasmodic
Therapeutic Area: Gastroenterology
Molecule Type: Synthetic Small Molecule
Mebeverine acts directly on the smooth muscle of the gastrointestinal tract.
Its antispasmodic activity helps reduce excessive intestinal smooth-muscle contraction while generally preserving normal intestinal motility.
Its pharmacological effects include:
Mebeverine HCl API is used in pharmaceutical formulations for:
Mebeverine HCl may be formulated as:
Mebeverine Hydrochloride is generally handled as a white or almost white crystalline powder. Its physical characteristics, particle size and solid-state properties should be controlled according to the applicable API specification.
A controlled Mebeverine HCl API manufacturing process may involve:
Typical Mebeverine HCl API testing may include:
Store Mebeverine HCl API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should follow validated stability data.
Mebeverine HCl is relevant to research involving:
Mebeverine Hydrochloride is a gastrointestinal antispasmodic API with CAS Number 2753-45-9, molecular formula C25H36ClNO5, and molecular weight 466.01 g/mol. It is primarily used in oral pharmaceutical formulations for the symptomatic management of gastrointestinal spasms and conditions such as irritable bowel syndrome.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 6.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |