Impurity Studies

Impurity synthesis and analysis is a very important step during the development of new chemical products. Impurities are chemicals, other than the main active ingredients, generated during the production, storage and other processes. The presence of the impurities affects the safety and the stability. So the production, storage and other processes must be strictly controlled to avoid the formation of impurities. The impurity is an important indicator of the quality control. Qualitative and quantitative analysis of impurities are always required in reporting, new product developments and quality control.

In the qualitative analysis of impurities a preliminary analysis by the instrument detection methods is always firstly carried out, presumably using HPLC, GC, UV and IR spectroscopy, liquid chromatography-mass spectrometry. The possible structure of impurities will be deduced. Then it will be compared with the proposed impurity standard to confirm the deduction. However, these standards are always unavailable from regular reagent companies. Besides, because different companies have different production routes and reaction conditions, the impurities could be different, which bring a lot difficulties to the company who is performing the analysis of these impurities. The project is always delayed because of impurity analysis step.

Our company has long been engaged in impurities custom synthesis service for companies providing custom synthesis service of impurity standards. Especially, our company offers a variety of impurity standard packages, assisting our customers to complete impurities qualitative research efficiently. At present, we have a large impurities standard library. Many famous companies, government agents have become our customers.