Requirements for Validating a Capillary Isoelectric Focusing Method for Impurity Quantitation

Requirements for Validating a Capillary Isoelectric Focusing Method for Impurity Quantitation

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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.