N-Metil-o-fenilenodiamina dihidrocloreto (CAS 25148-68-9) é uma impureza aromática básica tipicamente encontrada como subproduto de metilação ou cloração incompleta. Caracteriza-se por alta polaridade | solubilidade em água e solventes polares | ponto de fusão reduzido e sensibilidade à oxidação formando espécies coloridas; pode ser higroscópica. O controle analítico recomenda HPLC com detecção UV | LC-MS para identidade e quantificação | e 1H NMR para confirmação estrutural; testes de pureza devem seguir limites conforme ICH Q3A/B | com limites de impurezas genéricas e ligadas ao cloreto. Condições de armazenamento anóxico e uso de agentes redutores limitam a degradação e garantem estabilidade.
Referências
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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