Validation of the ICP-MS Method for Determination of Trace Elements Provided by ICH Q3D Guideline in Fosamprenavir Calcium
Fosamprenavir calcium is an active pharmaceutical ingredient (API) in which trace elements must be monitored by ICH Q3D Guideline. It delivers appropriate method to ensure the quality of the product and its safe use. Elemental impurities in API are separated in three classes based on their toxicity...
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Autores principales: | Irena Radić, Mislav Runje, Matija Cvetnić, Maja Halužan, Mario-Livio Jeličić, Martina Miloloža, Dajana Kučić Grgić, Viktorija Prevarić, Šime Ukić, Tomislav Bolanča |
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Formato: | article |
Lenguaje: | EN HR |
Publicado: |
Croatian Society of Chemical Engineers
2021
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Materias: | |
Acceso en línea: | https://doaj.org/article/45a2082285ce45c18835972eff2dd6db |
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