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The production process of 3-(4-piperidinyl)-1,2-benzisoxazole hydrochloride involves several steps, each of which requires careful control and attention to detail to ensure the quality of the final product.
The manufacturing process can be broken down into several stages, including synthesis, purification, and formulation.
Synthesis of 3-(4-Piperidinyl)-1,2-benzisoxazole:
The synthesis of 3-(4-piperidinyl)-1,2-benzisoxazole involves a series of chemical reactions that require careful control and monitoring to ensure the quality of the final product.
The synthesis process typically involves the following steps:
- Preparation of starting materials: The synthesis of 3-(4-piperidinyl)-1,2-benzisoxazole requires the use of several starting materials, which must be prepared carefully to ensure their purity and quality.
This typically involves the synthesis of these materials through a series of chemical reactions, followed by purification to remove any impurities. - Diazotization of benzene: In this step, benzene is treated with sodium nitrate and hydrochloric acid to form a diazonium salt, which can then be coupled with other compounds to form the desired product.
- Coupling of benzene with piperidine: The diazonium salt formed in the previous step is then treated with piperidine to form a new compound, which is then reacted with sodium hydroxide to form the desired product.
- Purification of the product: The final product is purified through a series of chemical reactions and purification steps to remove any impurities and ensure its quality.
This typically involves the use of chromatography, crystallization, and other techniques.
Purification of 3-(4-Piperidinyl)-1,2-benzisoxazole:
The purification of 3-(4-piperidinyl)-1,2-benzisoxazole involves a series of chemical reactions and purification steps to remove any impurities and ensure the quality of the final product.
The purification process typically involves the following steps:
- Crystallization: The final product is typically crystallized to remove any impurities and improve its stability.
- Chromatography: The crystallized product is then passed through a chromatography column, which separates the product from any impurities based on its chemical properties.
- Recrystallization: The purified product is then recrystallized to improve its purity and stability.
- Determination of optical rotation: The final product is then tested for its optical rotation, which is a measure of its purity and quality.
Formulation of 3-(4-Piperidinyl)-1,2-benzisoxazole Hydrochloride:
The final product, 3-(4-piperidinyl)-1,2-benzisoxazole hydrochloride, is then formulated into the desired dosage form, such as a tablet or capsule.
This typically involves the following steps:
- Granulation: The final product is mixed with a granulating agent, such as lactose or cornstarch, to form small granules that can be easily compressed into a tablet or capsule.
- Compression: The granulated product is then compressed into the desired dosage form using a tablet or capsule machine.
- Coating: The final product is then coated with a layer of polymer or other material to protect it from degradation and improve its stability.
- Packaging: The final product is then packaged in a suitable container, such as a bottle or blister pack, and labeled with the relevant information, such as the product name, dosage, and expiration date.
Quality control:
Throughout the production process, quality control tests are conducted to ensure that the final product meets the required standards for purity, stability, and potency.
This typically involves the use of various analytical techniques, such as