Pharmaceutical Impurities

Even at trace levels, unwanted chemicals present in pharmaceutical ingredients may greatly influence a drug product’s efficacy and safety. While researchers strive to eliminate or control impurities, they rely on fast analytical tools with high sensitivity and specificity to better detect, identify, quantitate and characterize impurities. The technology for impurity analysis has improved beyond the traditional chromatographic and spectroscopic methods. Scientists are gaining an ever-clearer picture of their materials’ constituents. In some cases, technology is revealing never-before-seen impurities even in compounds thought to be well understood.

Along with improving analytical tools comes a growing concern about genotoxins - molecules that may bind or alter DNA even in low parts-per-million concentrations.

Better information about pharmaceutical impurities is generating new questions. What is the best way to handle them? How should we report them? How do they really affect overall product quality? How should control procedures be put in place? Ingredient suppliers are working and debating with regulatory agencies to develop guidelines designed to eliminate redundant testing for APl’s, explain the composition of excipients, and reasonably control the genotoxic impurities in both.