Design of a strong cation exchange methodology for the evaluation of charge heterogeneity in glatiramer acetate.

Journal of Pharmaceutical and Biomedical Analysis(2017)

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摘要
•Strong cation exchange method to assess glatiramer acetate charge heterogeneity.•Relative retention time and symmetry factor are proposed for quality assessment.•The method was challenged through Analytical Target Profile and Validation tests.•The method is able to discern between glatiramer acetate and non-desired heterogeneity profiles.•The method was validated and is adequate for its intended purpose.
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% RTR,ATP,CQA,CV,GA,ICH,MP-PALS,NCA,PALS.,R2.,RME.,RP-UPLC,RRT,RT,RTs,RTwrs,SCX,SCX-UPLC,SE-UPLC,SF,WRS
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