Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods

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Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods

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作者：Abbie L. Esterman ; ^{abbie.esterman@bms.com" class="auth_mail" title="E-mail the corresponding author} ; Amit Katiyar ; Girija Krishnamurthy
关键词：Capillary electrophoresis sodium dodecylsulfate (CESDS) ; Monoclonal antibodies ; System suitability ; Reference standard ; US Pharmacopeia
刊名：Journal of Pharmaceutical and Biomedical Analysis
出版年：2016
出版时间：5 September 2016
年：2016
卷：128
期：Complete
页码：447-454
全文大小：2349 K

文摘

•: USP monoclonal antibody system suitability reference standard (SSRS) and evaluated using CE-SDS.
•: Method induced fragmentation was compared utilizing the USP and BMS optimized methods.
•: USP method caused greater method induced fragmentation compared with the BMS method.
•: Recommend using SSRS only during method development and phase appropriate validation.

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