El Amlodipine Deschloro Impurity (CAS 88150-52-1) es un derivado desclorado del amlodipino relevante en el control químico y farmacéutico por su impacto en el perfil de impurezas. Se caracteriza por pérdidas de cloro en la estructura fenil | detectándose mediante HPLC con detección UV | espectrometría de masas y RMN para confirmación estructural. Su presencia puede originarse por deshalogenación en etapas sintéticas o degradación durante almacenamiento | por lo que su cuantificación y límites están sujetos a las guías regulatorias ICH Q3A Q3B. Ofrecemos especificaciones analíticas | métodos validados y material de referencia para soporte en estudios de estabilidad y control de calidad.
Referencias
Bulsara, Kishen G., and Manouchkathe Cassagnol. Amlodipine.” Nih.gov, StatPearls Publishing, 13 Oct. 2019, www.ncbi.nlm.nih.gov/books/NBK519508/. Fares, Hassan, et al. Amlodipine in Hypertension: A First-Line Agent with Efficacy for Improving Blood Pressure and Patient Outcomes.” Open Heart, vol. 3, no. 2, Sept. 2016, p. e000473, https://doi.org/10.1136/openhrt-2016-000473.
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