The quality of sildenafil active substance of illegal source

• Published in: Journal of pharmaceutical and biomedical analysis 2016-11, Vol.131, p.133-139
• Main Authors: Keizers, Peter H.J., Wiegard, Andrea, Venhuis, Bastiaan J.
• Format: Article
• Language: English
• Subjects: Active substance; Counterfeit Drugs - analysis; Erectile Dysfunction - drug therapy; Humans; Illegal medicines; Male; Quality; Sildenafil; Sildenafil Citrate - analysis; Sildenafil Citrate - standards; Sildenafil Citrate - therapeutic use; Spectroscopy, Fourier Transform Infrared - methods; Tandem Mass Spectrometry - methods
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2016.08.027

[Display omitted] •Two examples are shown in which the sildenafil active substance was not of European Pharmacopeia quality.•In one case milligram-scale amounts of a 2-mercaptobenzothiazole contamination were found, in another case the mesylate salt rather than the monograph based citrate was used.•For the user of products containing these active substances the risks of side effects increase through the inherent properties of the impurity and the chance of overdosing.•Users are most likely not aware of the poor quality of the products, which adds up to the health risk of using prescription medication without consulting medical professionals. There must be a large market for active pharmaceutical ingredients of illegal source to support the huge and lucrative business of trade in illegal medicines. The active substances found in illegal pharmaceuticals may differ from their legal counterparts concerning purity and associated risks for the health of the user. In this study we show two examples in which the active substance sildenafil, used in erectile dysfunction products, was not of European Pharmacopeia quality. In one case milligram-scale amounts of a 2-mercaptobenzothiazole contamination were found, in another case the mesylate salt rather than the monograph based citrate was used. For the user of products containing these active substances, the risks of side effects increase through the inherent properties of the impurity and the chance of overdosing. The fact that the users are most likely not aware of the poor quality of the products adds up to the health risk of using prescription medication without consulting medical professionals.