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European Pharmacopoeia Paracetamol Monograph: Achieving Improved Separation for Paracetamol and All 14 Related Substances using Kinetex 2.6 µm C18
In this technical note, we have addressed identified issues with the current European Pharmacopoeia (Ph. Eur.) monograph method for the separation of paracetamol and 14 related substances. By leveraging both particle morphology and column selectivity, we were able to provide improved resolution for paracetamol and the principal degradation product, 4-aminophenol (impurity K), an impurity that can be formed by the hydrolysis of paracetamol. In addition, resolution of all 14 related impurities was achieved.
European Pharmacopoeia Paracetamol Monograph: Achieving Improved Separation for Paracetamol and All 14 Related Substances using Kinetex 2.6 µm C18
In this technical note, we have addressed identified issues with the current European Pharmacopoeia (Ph. Eur.) monograph method for the separation of paracetamol and 14 related substances. By leveraging both particle morphology and column selectivity, we were able to provide improved resolution for paracetamol and the principal degradation product, 4-aminophenol (impurity K), an impurity that can be formed by the hydrolysis of paracetamol. In addition, resolution of all 14 related impurities was achieved.
European Pharmacopoeia Paracetamol Monograph: Achieving Improved Separation for Paracetamol and All 14 Related Substances using Kinetex 2.6 µm C18
In this technical note, we have addressed identified issues with the current European Pharmacopoeia (Ph. Eur.) monograph method for the separation of paracetamol and 14 related substances. By leveraging both particle morphology and column selectivity, we were able to provide improved resolution for paracetamol and the principal degradation product, 4-aminophenol (impurity K), an impurity that can be formed by the hydrolysis of paracetamol. In addition, resolution of all 14 related impurities was achieved.