Monitoring of residuals is of key importance in the control of process related impurities and is a requirement of the ICH Q6B guidelines, a document adopted by regulatory agencies. If product quality is to be assured, it must be demonstrated that residuals are within agreed and well-defined limits. Furthermore, assessment of the levels of residuals at different stages of purification is important to help define the process of product manufacture. The techniques used for monitoring of a particular component must be sufficiently specific and sensitive such that low levels of the chemical can be readily detected and changes in those levels easily observed.
Mass spectrometry, when combined with suitable chemical procedures and chromatographic separation, proves to be a highly sensitive and versatile tool for the detection of low levels of residuals due to its ability to separate and precisely select for masses of interest, even when handling complex mixtures.
This Article, by BioPharmaSpec Technical Director Richard Easton, further discusses this topic.