High resolution separation of related compounds of Erythromycin using the new VWR-Hitachi ChromasterUltra Rs and LaChromUltra II C18 column with dimensions 250 x 3 (1.9 µm particle size).

Synthetic impurities as well as degradation products are becoming increasingly important in today’s analytical laboratories. Over the past few years there have been steps made by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to produce a consensus guideline on the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. In this current M7 step 2 draft document lower thresholds of impurities are mentioned.  It therefore appears that there will be a need in the near future for HPLC with improved sensitivity and resolution.