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The production process of perindopril L-arginine involves a series of chemical reactions and purification steps to produce the final product.
This process can be broken down into several stages, including raw material preparation, reaction, isolation, and purification.
Raw Material Preparation
The production of perindopril L-arginine begins with the preparation of raw materials.
The main raw material used in the production of perindopril L-arginine is L-arginine, which is an essential amino acid that is commonly found in proteins.
L-arginine is a white, crystalline powder that is soluble in water and has a slightly acidic taste.
The L-arginine used in the production of perindopril L-arginine must be of high purity and must meet strict quality standards.
Reaction
The next step in the production process is the reaction stage, where L-arginine is reacted with hydrochloric acid to produce L-arginine hydrochloride.
This reaction is exothermic, meaning that it releases heat, and must be carefully controlled to avoid any unwanted side reactions.
The reaction is typically carried out in a stainless steel reactor, which is equipped with a cooling system to remove excess heat.
The reaction is typically carried out at a temperature of around 20-30°C and is complete within a few hours.
Isolation
Once the reaction is complete, the L-arginine hydrochloride is isolated from any remaining impurities.
This can be achieved using a variety of methods, including filtration, centrifugation, and crystallization.
The isolated L-arginine hydrochloride is typically dried and pulverized to a fine powder to improve its flowability and consistency.
Purification
The final step in the production process is the purification of the L-arginine hydrochloride to produce perindopril L-arginine.
This involves several stages of purification, including ion exchange, gel filtration, and recrystallization.
These steps are designed to remove any remaining impurities and to produce a product that meets the required purity and quality standards.
Ion Exchange
The first stage of purification involves the use of ion exchange chromatography.
In this process, the L-arginine hydrochloride is passed through a column packed with a polymer resin that has a charged functional group.
The positively charged resin attracts and binds to the negatively charged L-arginine ions, while allowing the other impurities to pass through unchanged.
The bound L-arginine is then eluted from the column using a solution of a different pH, which causes the L-arginine to be released from the resin.
Gel Filtration
The next stage of purification involves the use of gel filtration chromatography.
In this process, the L-arginine hydrochloride is passed through a column packed with a gel-like substance, such as agarose or dextran.
The L-arginine molecules are too large to pass through the pores in the gel, while the smaller impurities can pass through and be collected separately.
Recrystallization
The final stage of purification involves the use of recrystallization.
In this process, the purified L-arginine hydrochloride is dissolved in a solvent, such as ethanol or acetone, and allowed to cool slowly.
The resulting crystals are then collected by filtration, washed with a small amount of solvent, and dried.
The resulting perindopril L-arginine is a white, crystalline powder that is typically further dried and pulverized to a fine powder.
Conclusion
The production process of perindopril L-arginine involves several stages, including raw material preparation, reaction, isolation, and purification.
These