Detection of Polyethylene Glycol Oxidation Products as Markers for the Release of Formaldehyde in a Pharmaceutical Product

摘要

During the analysis of 0.5 mg Baraclude tablets, elevated levels of an impurity known to be an entecavir-formaldehyde conjugate were detected. Due to the low strength of the tablets, the reaction with as little as 50 ng of formaldehyde produces a detectable impurity level in the 0.5 mg tablets.