Impurities Identification

Impurities Identification

Identifying impurities in a pharmaceutical product can be a stressful and worrying process. These contaminants are often discovered by non-specific detectors in analytical techniques like HPLC-UV Chromatography and can appear at any time during a drug’s life cycle. The first step is to determine what the impurity is, which can be a difficult and time-consuming process. This requires a validated internal process and access to sophisticated analytical methods like LC-ToF or GC-ToF, as well as NMR, in order to determine the structure of the contaminant. Obtaining analytical standards is also necessary in order to confirm the identity of the contaminant.

The next step is to understand where the impurity is coming from. This is important in order to avoid future occurrences and to determine the control limits. Relevant standards to consider include Residual Solvents, ICH M7, EMA, PQRI-PODP, and PQRI-OINDP. The root cause method can also be used to identify the possible source of the impurity, as described by the fishbone of Ishikawa. 

In conclusion, identifying impurities in pharmaceutical products is a complex and challenging process. It requires a thorough understanding of analytical methods and relevant standards, as well as an in-depth knowledge of the root cause of the problem in order to identify potential sources.

Video 01: Identifying Unknown Impurities