The Pharmacopoeial Discussion Group agreed on the international harmonization of copovidone, a pharmaceutical additive. Following this agreement, the tests of copovidone in European Pharmacopoeia (EP) have been revised in the 10th edition, which was implemented on the 1st of January, 2020.
The revision consists of the change of the analytical conditions of Impurity A (2-pyrrolidone) and newly added Impurities B and C (1-vinylpyrrolidin-2-one and vinyl acetate, respectively) tests. This technical note describes representative examples of these tests obtained with Inertsil ODS-4, which is opted for these tests.