Description

Mebeverine Hydrochloride is a high-purity pharmaceutical active ingredient, a direct-acting antispasmodic agent that targets the smooth muscle of the gastrointestinal tract. Its primary value lies in providing reliable and effective relief from symptoms associated with irritable bowel syndrome (IBS) and other functional gastrointestinal disorders. This compound is essential for manufacturers in the global pharmaceutical industry developing antispasmodic and anticholinergic medications, requiring consistent quality and supply chain integrity for formulation into tablets, capsules, and other dosage forms.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of prescription and over-the-counter medications for gastrointestinal spasms.
• Irritable Bowel Syndrome (IBS) Therapy: Key component in drugs designed to alleviate abdominal pain, cramping, and bloating associated with IBS.
• Functional Gastrointestinal Disorder Treatment: Used in medications for conditions like functional abdominal pain and diverticular disease.
• Antispasmodic Drug Manufacturing: Serves as the core API in antispasmodic preparations that relax smooth muscle without affecting normal gut motility.
• Clinical Research & Development: Utilized as a reference standard or raw material in preclinical and clinical studies for new gastrointestinal therapeutics.
• Generic Drug Production: Critical for manufacturers producing bioequivalent versions of branded mebeverine hydrochloride medications.

Basic Information

Product Name	Mebeverine Hydrochloride
CAS No.	2753-45-9
Molecular Formula	C25H35NO5 • HCl
Molecular Weight	466.01 g/mol
Synonyms	Mebeverine HCl; 4-[Ethyl[1-(4-methoxyphenyl)propan-2-yl]amino]butyl 3,4-dimethoxybenzoate hydrochloride; Duspatalin (trade name); Colofac (trade name); Mebeverini hydrochloridum; (RS)-Mebeverine hydrochloride; 3,4-Dimethoxybenzoic acid 4-[ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl ester hydrochloride
EINECS	220-403-6

Quality Control

Our Mebeverine Hydrochloride is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and BP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profile analysis, and residual solvent screening to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) documenting all test results is provided with each shipment to guarantee traceability and quality assurance for our B2B partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with EP/USP requirements

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.