Clopidogrel EP Impurity A (HCl-Salz), CAS 144750-42-5, ist das Hydrochlorid des Clopidogrel-Acid-S-Isomers, auch als Clopidogrel Related Compound A bezeichnet. Mit der Summenformel C15H15Cl2NO2S und einer Molekülmasse von 344,26 g/mol für das Salz handelt es sich um eine stereochemisch definierte, thienopyridinbezogene Verunreinigung, die mit der asymmetrischen Synthese und möglicher Epimerenverschleppung während der Herstellung verbunden ist. Diese Verbindung ist strukturell keine Nitrosamin-Verunreinigung und wird üblicherweise als prozessbedingte Verunreinigung im Rahmen von ICH Q3A und Q3B bewertet. Die Spurenbestimmung erfordert meist orthogonale chromatographische Trennung mittels chiraler oder RP-HPLC sowie Bestätigung durch LC-MS/MS und gegebenenfalls HRMS.
References
Ferraboschi, Patrizia, et al. “Chemo-Enzymatic Approach to the Synthesis of the Antithrombotic Clopidogrel.” Tetrahedron: Asymmetry, vol. 21, no. 17, Sept. 2010, pp. 2136–41, https://doi.org/10.1016/j.tetasy.2010.06.040. ?“Clopidogrel–Drug Interactions”: Journal of the American College of Cardiology, 2013, www.jacc.org/doi/abs/10.1016/j.jacc.2010.11.024.
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