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The production process of 2-amino-4,5,6,7-tetrahydropyrano[3,4-d]benzoxazepine-9-carboxylic acid methyl ester, also known as ACE-031, involves a multi-step synthesis process that involves several chemical reactions and purification steps.
The final product is a substance that has been shown to have potential as a treatment for pulmonary arterial hypertension, and its production requires strict quality control and purification to ensure its efficacy and safety.
Step 1: Synthesis of 2-nitro-4,5,6,7-tetrahydrobiimidazo[1,2-d]benzoxazepine
The production process of ACE-031 begins with the synthesis of 2-nitro-4,5,6,7-tetrahydrobiimidazo[1,2-d]benzoxazepine, which is a key intermediate in the synthesis of ACE-031.
This intermediate is synthesized through a multi-step reaction sequence that involves the condensation of several organic compounds in the presence of reagents such as hydrochloric acid and sodium hydroxide.
The reaction sequence involves several steps, including the preparation of the starting materials, the reaction mixture, and the isolation and purification of the intermediate product.
Step 2: Synthesis of 2-amino-4,5,6,7-tetrahydropyrano[3,4-d]benzoxazepine
The next step in the synthesis of ACE-031 is the synthesis of 2-amino-4,5,6,7-tetrahydropyrano[3,4-d]benzoxazepine, which is another key intermediate in the synthesis of the final product.
This intermediate is synthesized through a multi-step reaction sequence that involves the condensation of several organic compounds in the presence of reagents such as hydrochloric acid and sodium hydroxide.
The reaction sequence involves several steps, including the preparation of the starting materials, the reaction mixture, and the isolation and purification of the intermediate product.
Step 3: Synthesis of 2-amino-4,5,6,7-tetrahydropyrano[3,4-d]benzoxazepine-9-carboxylic acid
The final step in the synthesis of ACE-031 is the synthesis of 2-amino-4,5,6,7-tetrahydropyrano[3,4-d]benzoxazepine-9-carboxylic acid, which is the desired final product.
This is synthesized through a multi-step reaction sequence that involves the condensation of several organic compounds in the presence of reagents such as hydrochloric acid and sodium hydroxide.
The reaction sequence involves several steps, including the preparation of the starting materials, the reaction mixture, and the isolation and purification of the final product.
Purification and Quality Control:
The final product, 2-amino-4,5,6,7-tetrahydropyrano[3,4-d]benzoxazepine-9-carboxylic acid methyl ester, is a highly potent and selective modulator of the serotonin 2B receptor.
The production of this compound requires strict quality control and purification to ensure that the final product meets the required specifications for purity and efficacy.
This involves the use of several techniques, including high-performance liquid chromatography (HPLC), mass spectrometry, and spectroscopic analysis.
The final product is also tested for its ability to bind to the serotonin 2B receptor and its effectiveness in reducing pulmonary arterial hypertension in animal models.
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