Post-processing optimization of intermediate API

Impurity spectrum analysis. During the small-scale test,Intermediate API although some impurities have been analyzed, unfortunately, during the amplification process,Intermediate API the reaction time is longer than the small-scale test time (process tolerance issues need to be fully considered,Intermediate API and it is often necessary to pass the destruction during the small-scale test. It can be defined by sex experiment),Intermediate API there are blind spots in dripping,Intermediate API post-processing, and stirring,Intermediate API which often cause more impurities during the pilot test than during the pilot test. Therefore, it is necessary to check the impurity spectrum and the pilot test after the pilot test. The impurity spectrum is analyzed. In addition,Intermediate API it is also necessary to consider whether new impurities similar to genotoxicity will be produced. Genotoxic impurities have relatively high requirements in the formal or informal markets, so full attention should be paid to them. For details,Intermediate API please refer to the literature on genotoxic impurities.

Post-processing optimization. In the small-scale test process, because the amount of feed is relatively small,Intermediate API some small-scale test samples are often unable to obtain good solid samples, especially low-melting intermediates or APIs of nitrogen-containing compounds. After magnification, because the sample size is relatively large,Intermediate API it is easier to produce crystal nuclei. It is often impossible to obtain solid samples during the small test process,Intermediate API and it is often easy to obtain high-level samples after proper magnification. At this time, it is necessary to increase the monitoring after the reaction is processed and before the purification of the sample. One of the projects I have experienced is the need to recrystallize during the small test, but after amplification,Intermediate API the purity of the product precipitated by the direct reaction system can meet the shipping requirements. Thereby reducing the production cycle and cost.

In addition,Intermediate API during the purification process,Intermediate API if a small-scale purification method is not feasible, it can also be verified in the pilot-scale process. In addition,Intermediate API the author has also experienced a certain project. During the crystallization process,Intermediate API if stirring is used for crystallization, the samples obtained are all yellow solids (the color of the mother liquor is the same),Intermediate API and the samples obtained by static crystallization are not white. solid of.

Tag: Intermediate API

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