General process introduction of API and intermediate process

The layout of the original research manufacturer of the raw material drug,Intermediate API the manufacturer’s compound patents, and the process patent layout;Intermediate API the layout of the patents of other imitation manufacturers (this part belongs to the intellectual property rights,Intermediate API and it is often necessary to pay attention to the patent status during the investigation process). Quality standard survey: the purity of intermediates and APIs published by the original research in patents or literature (such as JMC) or the standards of listed manufacturers,Intermediate API pharmacopoeias (EP5.0, EP6.0, EP6.6, USP38, BP2009);Intermediate API as listed in the literature Not specifically mentioned, you can refer to the common practice,Intermediate API the purity of the intermediate is generally to purity>99%, single impurity <0.5%, API purity>99.5%,Intermediate API and maximum single impurity <0.1%.

Determine the crystal form (solid API): API (under different crystallization conditions, Intermediate API the same API often results in a variety of different crystal forms, but often only one or two or a mixed crystal form is a medicinal crystal form ) Preparation method of medicinal crystal form.

Analytical method research: Analytical method is the most important issue in process development. In the process of literature research,Intermediate API some documents and patents sometimes give intermediate control and analysis methods of API and even the model of the column. Specifications and parameters will be listed. Such reference can reduce the time and pressure of analytical method development. In addition,Intermediate API the analysis method is not disclosed in the literature and patents. According to the structure of the compound,Intermediate API you can search for compounds with similar structures (focus on the functional groups in the structural formula).

Synthetic route: In the investigation of API and intermediates,Intermediate API the most important thing is the synthetic route. The determination of the synthetic route often requires redesigning or synthesizing several patents or literature methods. Good use of existing synthetic routes and methods,Intermediate API and combining the advantageous reaction steps and methods in various patent documents into new routes, can make the work more effective.

Material market research: starting materials (KSM), prices of APIs (regular and informal markets),Intermediate API supplier qualification surveys (special materials involving special reactions, often after changing suppliers,Intermediate API timely quality testing Any difference in the process, but it is often impossible to make it, especially for catalytic and coupling types of reactions).

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