ISP Standards’ expertise

ISP Standards’ expertise can help ensure accurate data for even the most complex impurities.

Synthesis of impurities is a useful tool in impurity studies. By matching the spectral and chromatographic profiles for the impurity with that of the synthesized compound, its structure can be verified. The synthesized impurity can then be studied further to understand its toxicological effect, as well as its formation mechanism. This knowledge can inform regulations and be used to optimize the synthetic process and drug formulation, ensuring safe purity levels are maintained.