Setting new drug specifications - An outsourcing API supplier s perspective

摘要

All new Active Pharmaceutical Ingredients (APIs) need to be made to certain purity levels. Guidance is available on setting new drug specifications (1) at Registration (2) but there is little for those in late discovery or early development. Specifications during early development are often based on what is expected at Registration but this does not necessarily have to follow. Moreover, this approach may not be the best way to set specifications. During early screening, drug purity may be as low as 85% but as soon as hits are obtained, purity will be improved in order to minimise the possibility of impurities accounting for the observed activity. As a lead compound progresses through early development, purity targets may approach the high nineties percent.