A Somatropin Counterfeit Challenging the European Pharmacopoeia Monograph

Samples of a substance purported to be somatropin were submitted to the European Department for the Quality of Medicines laboratory for investigation by the German Medicines Control Authorities. Complete characterization of the sample was performed by a combination of liquid chromatography-mass spectrometry and amino-terminal sequencing. These data demonstrated that the active ingredient was not somatropin but des-Phe1 -human somatropin. The batch of product did not comply with the specifications in the European Pharmacopoeia monograph on Somatropin for Injection (0952), and so could not be released on the European market. Analytical procedure is a field of rapidly evolving technology. Nevertheless, despite the introduction of highly sophisticated technology used in the develoment of medicinal products, this paper indicates that classical analytical procedures in combination with appropriate specifications are still valuable tools for monitoring the quality control of medicinal products.