Peak purity assessment in a triple-active fixed-dose combination drug product related substances method using a commercial two-dimensional liquid chromatography system
Author:
Affiliation:
1. Analytical and Bioanalytical Development; Bristol-Myers Squibb Company; New Brunswick NJ USA
Publisher
Wiley
Subject
Filtration and Separation,Analytical Chemistry
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/jssc.201400515/fullpdf
Reference31 articles.
1. Forced degradation and impurity profiling: Recent trends in analytical perspectives
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3. Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 2005
5. Formulation design, challenges, and development considerations for fixed dose combination (FDC) of oral solid dosage forms
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