EMEA to address specs for impurities in fermented antibiotics

“The Gold Sheet” August 2008, Vol. 42, No. 008
Word Count: 73 / Article # 08420081011_b

Executive Summary

The European Medicines Agency July 9 issued a concept paper for a guideline on setting specifications for related impurities in antibiotics. Current guidelines set impurities thresholds for antibiotics produced by chemical synthesis, but not for those produced by fermentation or fermentation followed by synthesis. Specifications and tests are difficult to establish for such products because they usually include many closely related substances, some of which are active ingredients and others impurities, EMEA said