原料药工艺研发 API Process Research Development.pptx

API PROCESS research  Development;API PROCESS research  Development;What is Process Chemistry?;What is process research development ?;The Ultimate Goal of Process Development is to Scale-Up ; To study establish the process control. 2. To study the safety issue of process. 3. Identify the problematic issue for scale-up. 4. To address the patent issues. 5. To verify the consistency in quality quantity. 6. To establish all the regulatory requirements. 7. Cost effectiveness. ;Prerequisites;Process Considerations;Patent infringement Analysis;Inconsistent Quality of Raw Materials;Cost of Product ;Process Adaptability;  5. Reactions involving low temperatures or high pressures could be difficult to handle in the plant, and an alternative route should be considered  6. Methods of handling viscous materials in a plant also must be taken into account because the large surface area of plant equipment and piping can pose problems during material transfer.   7. Solutions to these problems include performing one-pot reactions using a suitable solvent to transfer such materials . ;Process Scale-up Issues;Simulating the RD plant environment.;Determining the scale-up factor;Critical Observations; Critical Process Parameters (CPP); Critical Process Parameters (CPP); Chemical Compatibility Studies/Leaching Studies;In the absence of such data, in-house data should be generated by simulating the exact contact conditions in a laboratory experiment, and the observations should be recorded. To determine the compatibility of a filter cloth with a process fluid: A sample piece of the filter cloth can be kept in contact with the process fluid for a specified time, temperature, or pressure in a laboratory, and the effect of such fluid on the weight, size, shape, color, elasticity, texture, and so forth of the sample cloth can be recorded. Such observations can help determine the suitability of using various