Impureza (2S | 3R)-3-Hydroxy-2-(4-methoxyphenyl)-2 | 3-dihydrobenzo[b][1 | 4]thiazepin-4(5H)-one (CAS 132830-16-1) apresenta centro estereogênico duplo que exige controle de pureza enantiomérica e monitoramento de epimerização. Sua função hidroxila e o anel tiazepinona aumentam polaridade e influenciam retenção em cromatografia reversa | enquanto o grupo metoxi modula lipofilicidade e absorção UV útil para detecção por HPLC-UV. Esta impureza pode surgir por ciclização incompleta | oxidação do enxofre ou reações laterais durante síntese e armazenamento. Estratégias analíticas recomendadas incluem HPLC-MS | HPLC quiral | RMN e espectroscopia IR | com especificações alinhadas às diretrizes ICH para controle de impurezas.
Referências
“Diltiazem: MedlinePlus Drug Information.” Medlineplus.gov, 2017, medlineplus.gov/druginfo/meds/a684027.html.
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