Alfacalcidol EP Impurity A (trans-Alfacalcidol | CAS 65445-14-9) é uma impureza isomérica relevante em lotes de alfacalcidol que exige controle rigoroso. Caracteriza-se por configuração trans | propriedades cromatográficas próximas ao princípio ativo e resposta detectável por HPLC | LC-MS e RMN | tornando imprescindível validação de métodos analíticos específicos para quantificação e identificação. A sua presença pode indicar isomerização durante síntese ou armazenamento | por isso limites de especificação | critérios de identificação e perfil de degradação devem ser estabelecidos conforme monografias EP. Procedimentos de amostragem | condições de estocagem e testes de estabilidade são essenciais para garantir conformidade regulatória e qualidade do produto final.
Referências
Holick, M. F., et al. “1a-Hydroxy Derivative of Vitamin D 3 : A Highly Potent Analog of 1a, 25-Dihydroxyvitamin D 3.â€Â Science, vol. 180, no. 4082, Apr. 1973, pp. 190–91,  https://doi.org/10.1126/science.180.4082.190. de Nijs, Ron N. J., et al. “Alendronate or Alfacalcidol in Glucocorticoid-Induced Osteoporosis.†New England Journal of Medicine, vol. 355, no. 7, Aug. 2006, pp. 675–84,  https://doi.org/10.1056/nejmoa053569.
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