Mexiletine Hydrochloride (CAS 5370-01-4) is a well-defined chemical compound with a specific profile that makes it invaluable in the pharmaceutical industry, particularly as an antiarrhythmic agent. Understanding its chemical characteristics is key for anyone looking to purchase or utilize this API from a reputable manufacturer.

Chemically, Mexiletine Hydrochloride is described as a white or almost white crystalline powder. Its molecular formula is C11H18ClNO, with a molecular weight of approximately 215.72 g/mol. A critical characteristic for pharmaceutical applications is its solubility. Mexiletine Hydrochloride is freely soluble in water and methanol, and sparingly soluble in methylene chloride. This solubility profile is advantageous for formulators, allowing for easier integration into various pharmaceutical preparations, whether for oral or potentially other delivery methods.

The quality standards for pharmaceutical-grade Mexiletine Hydrochloride are rigorous. Typical specifications include a high assay, usually between 99.0-101.0%, ensuring minimal variation in potency. Limits on impurities, heavy metals, and water content are strictly controlled. For instance, water content is typically kept at ≤0.5%, and total impurities are often limited to ≤0.1%. Sourcing from a trusted manufacturer, such as those found in China, is essential to guarantee these purity levels. Companies engaged in the bulk purchase of this compound rely on suppliers who can consistently meet these demanding specifications.

When purchasing Mexiletine Hydrochloride, it's imperative to work with a supplier that can provide detailed documentation, including Certificates of Analysis (CoA) and Safety Data Sheets (SDS). These documents verify the chemical's purity and handling requirements. Choosing a manufacturer that prioritizes quality control and offers competitive pricing makes them an ideal partner for businesses in the pharmaceutical sector.