1.
Methods Mol Biol
; 276: 121-36, 2004.
Artigo
em Inglês
| MEDLINE
| ID: mdl-15163855
RESUMO
A method for determining the purity of recombinant carboxypeptidase B utilizing CE-SDS has been developed and validated for use in a manufacturing quality control laboratory. The method was optimized, prior to validation, to allow for the lowest limit of quantitation. The method was validated with the typical ICHQ2A parameters, including accuracy, linearity, LOQ, precision, robustness/ruggedness, and specificity. All validation parameters met the acceptance criteria defined in the validation protocol.