Detailed data on reaction conditions and crystallization conditions can be obtained, leading to quality assurance through the manufacturing process!
We would like to introduce our "Process Chemistry Development Using PAT." The quality of active pharmaceutical ingredients (APIs) is believed to depend on the depth of understanding of the manufacturing process. By using PAT, detailed data on reaction conditions and crystallization conditions can be obtained, leading to assurance of quality through the manufacturing process. If formulation does not proceed well, such as unstable dissolution test results, the cause may lie in the crystal form of the API. PAT allows for real-time monitoring of the crystallization process. 【Features】 ■ Setting of reaction conditions ■ Setting of crystallization conditions ■ Setting of manufacturing processes *For more details, please refer to the related links or feel free to contact us.
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【Details】 ■Based on the requests of ICH guidelines, reaction conditions are set using the concepts and technologies of PAT to analyze and understand the reactions. ■Capture reaction intermediates that cannot be detected by TLC or HPLC using ReactIR, and determine the appropriate timing for changing reaction temperature or adding reagents. ■While understanding the compounds through analysis of solubility, crystallization rate, etc., using PAT, set conditions such as concentration, stirring speed, temperature, time, and seed crystal addition. ■Select the crystallization solvent to be examined using a solubility screening panel*. ■Create solubility versus supersolubility curves using ParticleView. ■Once the reaction and crystallization conditions are determined, set the manufacturing process. ■Consider the entire manufacturing process, including which operations to perform in what order and which equipment to use for efficiency. *For more details, please refer to the related links or feel free to contact us.
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Do you have any of these concerns? - Unable to find an active pharmaceutical ingredient manufacturer that can handle everything from non-GMP to GMP - Want to adapt traditional manufacturing methods to current guidelines - No active pharmaceutical ingredient manufacturers that can accommodate small quantities - Want to request the development of manufacturing methods that other manufacturers couldn't achieve - Concerned about overseas active pharmaceutical ingredient manufacturers; prefer domestic ones - Worried about NDMA, etc. *For more details, please refer to the related links or feel free to contact us.
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Since our establishment, we have been supplying pharmaceutical raw materials to various pharmaceutical companies both domestically and internationally. We mainly focus on items that require complex synthesis routes and lengthy processes, as well as niche raw materials with few suppliers, even in small quantities. Please feel free to consult us if you have any requests.