European Pharmacopoeia Paracetamol Monograph: Achieving Improved Sensitivity, Resolution, and Separation for Paracetamol and All 14 Related Substances

Abstract:

N-(4-hydroxyphenyl) acetamide, commonly referred to as paracetamol in Europe and acetaminophen in the USA, is one of the most familiar analgesics and antipyretic therapeutics in today’s drug market. As a result of its wide usage and applicability, there is significant interest in the development of fast and efficient analysis of paracetamol and related impurities. 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.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Kinetex

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