European Pharmacopoeia Paracetamol Monograph: Achieving Improved Separation for Paracetamol and All 14 Related Substances using Kinetex® 2.6 μm C18

Abstract:

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. The Ph. Eur. method requires that resolution between impurity K and paracetamol be a minimum of 5.0 to meet system suitability; resolution significantly greater was achieved here. In addition, resolution of all 14 related impurities was achieved.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Kinetex

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