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. Fo r 38 historical batches these analyses have been complemented with P-3 1 NMR analysis. In this work we have used multivariate methods such as principal components analysis, discriminant projections to latent str uctures and pattern recognition to find a correlation between the old and the new analyses for batch approval. In this way it has been possi ble to establish a mathematical model for approving/not approving batc hes of Estradurin(R) based on 31 P NMR analysis. This should make it p ossible to replace the animal duration test.