La impureza Bacitracin EP Impurity O, también denominada Bacitracin J1, es un péptido cíclico de doce aminoácidos de mayor homología dentro del complejo bacitracina A/B/C, que suele originarse por microheterogeneidad asociada a la fermentación y por procesamiento postbiosintético de productos de Bacillus licheniformis. Con fórmula molecular C65H101N17O16S y peso molecular de 1408.7 g/mol, conserva la arquitectura peptídica con tiazolina característica de la familia bacitracina. La asignación estructural y la cuantificación a nivel traza requieren normalmente LC-MS de alta resolución, LC-MS/MS y mapeo peptídico, más que métodos UV rutinarios, debido a análogos isobáricos y variantes de secuencia estrechamente relacionadas. No es una nitrosamina ni una impureza reactiva con ADN según ICH M7.
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