CLASSIFICATION OF ESTRADURIN(R) BATCHES - CORRELATION BETWEEN P-31 NMR AND A BIOLOGICAL DURATION TEST FOR BATCH APPROVAL

The analyses used for batch approval of Estradurin(R) are a biological duration test on mice together with gel permeation chromatography. For 38 historical batches these analyses have been complemented with P-31 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(R) based on 31 P NMR analysis. This should make it possible to replace the animal duration test.