Cefaclor EP Impurity C | identificado como el isómero (2S) de cefaclor con CAS 143059-69-2 | es una impureza relevante a monitorizar en el control de calidad de materias primas y formulaciones. Su presencia modifica el perfil de impurezas y puede influir en la especificación de pureza; por ello se cuantifica mediante HPLC con detección UV y se confirma por LC-MS y RMN para establecer identidad y límites aceptables. Estudios de degradación ayudan a determinar su origen y las condiciones de formación. El establecimiento de límites basados en toxicidad y la validación de métodos analíticos garantizan el cumplimiento de la monografía EP y las prácticas de aseguramiento de calidad.
Referencias
“Cefaclor: MedlinePlus Drug Information.†Medlineplus.gov, Jan. 2022, medlineplus.gov/druginfo/meds/a682729.html.
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