The production of pharmaceutical-grade compounds like Lidocaine Hydrochloride (CAS 73-78-9) involves precise chemical synthesis and rigorous quality control. At NINGBO INNO PHARMCHEM CO.,LTD., we adhere to established manufacturing protocols to ensure the highest standards for this vital pharmaceutical ingredient.
The synthesis of Lidocaine Hydrochloride typically begins with 2,6-xylidine, a key aromatic amine. This precursor is reacted with chloroacetyl chloride in a process that forms an intermediate amide linkage, yielding 2-chloro-N-(2,6-dimethylphenyl)acetamide. The subsequent critical step involves the amination of this intermediate with diethylamine. This nucleophilic substitution reaction attaches the diethylamino group, forming the base molecule, lidocaine.
To convert lidocaine base into its hydrochloride salt, the free base is typically dissolved in a suitable solvent and then treated with hydrochloric acid. This acid-base reaction protonates the tertiary amine, forming Lidocaine Hydrochloride, which often precipitates out of the solution. Careful control of reaction conditions, including temperature, reactant stoichiometry, and reaction time, is essential to maximize yield and minimize the formation of by-products.
Following synthesis, the crude Lidocaine Hydrochloride undergoes purification steps, which may include recrystallization from appropriate solvents. This process is crucial for removing residual impurities and achieving the high purity levels (often exceeding 99%) required for pharmaceutical applications. Drying and milling processes then prepare the final product for packaging.
Quality control is integrated throughout the manufacturing process. From the sourcing of raw materials to the final product testing, each stage is monitored to ensure compliance with established specifications. Analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and spectroscopic methods are employed to verify the identity, purity, and potency of the Lidocaine Hydrochloride. NINGBO INNO PHARMCHEM CO.,LTD. is committed to these rigorous manufacturing and quality assurance practices when you buy Lidocaine Hydrochloride from us.
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1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;
2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;
3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).
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