Aciclovir EP Impurity J is a structurally related degradation byproduct arising from oxidative cleavage of the acyclic guanine moiety in aciclovir. It features a substituted purine core with an additional oxidized side chain containing a hydroxylated amino group and a carbonyl functionality, distinguishing it from the parent compound. The molecule exhibits enhanced polarity due to the introduction of two additional oxygen atoms and a branched nitrogen-containing side chain. This impurity is specifically employed as an HPLC reference standard for quantifying oxidative degradation pathways in aciclovir formulations under ICH Q1A(R2) guidelines.
On RequestC1=NC2=C(N1COCCOCN3C=NC4=C3N=C(NC4=O)N)N=C(NC2=O)N
InChI=1S/C14H16N10O4/c15-13-19-9-7(11(25)21-13)17-3-23(9)5-27-1-2-28-6-24-4-18-8-10(24)20-14(16)22-12(8)26/h3-4H,1-2,5-6H2,(H3,15,19,21,25)(H3,16,20,22,26)
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