Drug products can be excreted from the body in its original chemical state or it can be metabolized by the body in a process termed drug biotransformation. In the process of breaking the drug down to excrete it from the body, there is the potential of forming reactive intermediates which may cause adverse reactions. Thus, the FDA requires pharmaceutical companies to identify all metabolites of new chemical entities (NCEs).
It is important to identify drug metabolites for a number of reasons. The metabolites may be toxic or they may possess pharmacological activity. The metabolites may also provide new leads. Identification of metabolites also provides a better understanding of how the drug is being processed for excretion.
Identification of metabolites requires mass spectrometry techniques in order to elucidate the structure. At PBL, we have two LC-MS/MS units and a TOF/MS that are capable of providing the resolution and specificity needed to elucidate the structure of closely related metabolites of a drug compound. Pacific BioLabs has extensive experience in identifying drug metabolites and can help you with your drug product.