La impureza Telmisartan Bromo Methyl Ester (CAS 114772-38-2) es un contaminante orgánico relevante en la síntesis de telmisartán | caracterizado por la presencia de un grupo bromo-metilo esterificado que altera la polaridad y el perfil de retención cromatográfica del lote. Su identificación se realiza mediante LC-MS/ESI y espectroscopía 1H- y 13C-NMR | y su cuantificación por HPLC-UV empleando condiciones validadas. Debe monitorizarse como sustancia relacionada y establecerse límites en especificación para garantizar la pureza farmacéutica; su control incluye análisis de estabilidad | cribado de impurezas y medidas de mitigación en el proceso para evitar formación por alquilación inadvertida.
Referencias
Gosse, Philippe. “A Review of Telmisartan in the Treatment of Hypertension: Blood Pressure Control in the Early Morning Hours.†Vascular Health and Risk Management, vol. 2, no. 3, Aug. 2006, pp. 195–201, https://doi.org/10.2147/vhrm.2006.2.3.195. ‌
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