Classification of Estradurin® batches: correlation between 31P NMR and a biological duration test for batch approval

The analyses used for batch approval of Estradurin® are a biological duration test on mice together with gel permeation chromatography. For 38 historical batches these analyses have been complemented with 31P NMR analysis. In this work we have used multivariate methods such as principal components analysis, discriminant projections to latent structures and pattern recognition to find a correlation between the old and the new analyses for batch approval. In this way it has been possible to establish a mathematical model for approving/not approving batches of Estradurin® based on 31P NMR analysis. This should make it possible to replace the animal duration test.