Metformin EP Impurity E is a structurally related biguanide derivative arising from incomplete alkylation during Metformin synthesis. It retains a dimethylamino group but lacks the second methyl substitution on the guanidine moiety, resulting in a primary amine functionality adjacent to the amidine core. This impurity exhibits distinct HPLC retention due to its reduced hydrophobicity compared to the parent drug. It serves as a critical HPLC reference standard for quantifying this specific synthetic byproduct in Metformin API batches.
On RequestCN=C(N)N=C(N)N
InChI=1S/C3H9N5/c1-7-3(6)8-2(4)5/h1H3,(H6,4,5,6,7,8)
JLPWQEHTPOFCPG-UHFFFAOYSA-N