MEDIOCON INC is a trusted global manufacturer and supplier of Mexiletine Hydrochloride API in India, offering high-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Our APIs are supplied with appropriate quality documentation to support pharmaceutical development, manufacturing, and quality-assurance requirements.
Mexiletine Hydrochloride is an orally active Class IB antiarrhythmic active pharmaceutical ingredient and a local-anesthetic-type compound structurally related to lidocaine. It acts primarily by blocking fast sodium channels in cardiac tissue, thereby reducing abnormal electrical activity and helping stabilize cardiac rhythm. Mexiletine Hydrochloride is used in pharmaceutical formulations for the management of certain ventricular arrhythmias, particularly life-threatening ventricular arrhythmias such as sustained ventricular tachycardia.
Mexiletine Hydrochloride is the hydrochloride salt of mexiletine and is chemically identified as 1-methyl-2-(2,6-xylyloxy)ethylamine hydrochloride. It has the molecular formula C₁₁H₁₇NO·HCl, molecular weight 215.72 g/mol, and CAS Number 5370-01-4. Official drug labeling describes Mexiletine Hydrochloride USP as a white to off-white crystalline powder that is freely soluble in water and alcohol and has a pKa of approximately 9.2.
MEDIOCON INC supplies premium-quality Mexiletine Hydrochloride API to pharmaceutical manufacturers, contract manufacturing organizations (CMOs), contract research organizations (CROs), formulation companies, biotechnology companies, universities, research institutes, and analytical laboratories worldwide, supported with comprehensive documentation including COA, MSDS/SDS, technical data sheets, product specifications, analytical documentation, and applicable quality documents.
| Parameter | Specification |
|---|---|
| Appearance | White to Off-White Crystalline Powder |
| Identification | IR / HPLC / Chloride Complies |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 200°C – 204°C |
| Solubility | Freely soluble in water and alcohol |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Mexiletine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC (CAS 5370-01-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Mexiletine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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