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Atorvastatin ethyl ester is a widely used pharmaceutical drug used to lower cholesterol levels in the blood.
The production process of atorvastatin ethyl ester involves several stages, including the synthesis of the starting material, the formation of the ester, and the purification of the final product.
Synthesis of the Starting Material: The synthesis of the starting material, a mixture of di- and tri-hydroxy acids, is the first step in the production of atorvastatin ethyl ester.
This mixture is obtained by the reaction of chloral with malic acid in the presence of an alkaline catalyst.
The reaction is exothermic, and the mixture is cooled to prevent excessive heating.
Formation of the Ester: The next step in the production of atorvastatin ethyl ester is the formation of the ester.
This is achieved by the reaction of the mixture of di- and tri-hydroxy acids with ethanol in the presence of a strong acid catalyst, such as sulfuric acid.
The reaction is conducted at a temperature of around 60-65°C, and the progress of the reaction is monitored by thin-layer chromatography (TLC).
Once the reaction is complete, the mixture is cooled and neutralized with sodium hydroxide solution.
Purification of the Final Product: The final step in the production of atorvastatin ethyl ester is the purification of the final product.
This is achieved by the crystallization of the product from a solvent, such as ethanol or methanol.
The crystals are collected by filtration and dried under vacuum.
The dried crystals are then ground to a fine powder and passed through a sieve to remove any impurities.
The purified product is then subjected to a series of tests, including organoleptic tests, microbiological tests, and physicochemical tests, to determine its quality and purity.
The results of these tests are used to ensure that the product meets the required specifications and is suitable for use in pharmaceutical preparations.
Conclusion:
The production process of atorvastatin ethyl ester involves several stages, including the synthesis of the starting material, the formation of the ester, and the purification of the final product.
Each stage of the process must be carefully controlled and monitored to ensure the quality and purity of the final product.
The quality of the final product is determined by a series of tests, including organoleptic tests, microbiological tests, and physicochemical tests, which are conducted to ensure that the product meets the required specifications and is suitable for use in pharmaceutical preparations.
By following these steps, pharmaceutical companies can ensure that the final product is safe and effective for use in the treatment of high cholesterol levels.