Optimization of Synthesis Method and Quality Control of an Active Pharmaceutical Ingredient Denominate Chlorobutanol

Abstract Chlorobutanol is an active pharmaceutical ingredient used in therapeutic for many years as an antiseptic, analgesic and local anesthetic. It has other properties: hypnotic, anti-inflammatory and anti-emetic. It’s used as conservativein some pharmaceutical preparations because it has antibacterial and antifungal properties. We synthesized this active pharmaceutical ingredient in Therapeutic laboratory of pharmacy department of Sidi Bel-Abbes by Referenced method based on the addition of chloroform with acetone under the influence of chemical catalyst (potassium hydroxide) using the distillation assembly. The second synthesis using the optimized method improves the yield of 20 %. The synthesized product was controlled according to the requirements of the European Pharmacopoeia 8th edition: the organoleptic characteristics, solubility, colorimetric reactions and the degree of coloring were positive;its melting point is 78 °C; its water content is estimated to 4.66% and its purity is equal to 98.27%.

Keywords optimization, synthesis, Chlorobutanol, yield, control.

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Updated: January 20, 2024 — 8:24 am