Requirements for Validating a Capillary Isoelectric Focusing Method for Impurity Quantitation

A.S. Rathore;R.R. Kurumbail;A.M. Lasdun;

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Requirements for Validating a Capillary Isoelectric Focusing Method for Impurity Quantitation

November 1, 2002

A.S. Rathore, R.R. Kurumbail, A.M. Lasdun

LCGC North America

LCGC North America, LCGC North America-11-01-2002, Volume 20, Issue 11

The guest authors present a strategy for validating a capillary isoelectric focusing method intended to quantitate impurities in a protein drug substance.