Orbitrap Illustration

Drug Impurities Analysis

Although the goal of any synthetic process is to create the pure desired product, the realities of chemical synthesis and manufacturing mean that impurities are often present in final products. These impurities may give rise to toxicities, which are the primary driving force behind careful impurities analysis. Understanding what these impurities are, whether in active pharmaceutical ingredients (API), excipients used in drug manufacturing, or in other areas of research and manufacturing, is important to assure the quality and safety of the finished product. Degradation products, either from storage or from exposure to environmental or operational conditions, are also an important area of interest.

Workflow Overview for Drug Impurities Analysis

Impurities in products often represent minor components, and the ability to detect these in the presence of significant product is a challenge. Once detected, the need to assign a structure to the impurity or degradantis the next challenge.  Both of these challenges are aided by Orbitrap™ technology. The high sensitivity and wide dynamic range of the Thermo Scientific Orbitrap Elite MS means that even minor components can be detected and valuable data gathered, while MSn fragmentation aids in structure determination.




Simultaneous, Fast Analysis of Melamine and Analogues in Pharmaceutical Components Using Q Exactive - Benchtop Orbitrap LC-MS/MS

Comstock K, Stratton T, et al.
ASMS 2012 Poster