Peak purity assessment in a triple-active fixed-dose combination drug product related substances method using a commercial two-dimensional liquid chromatography system-Reference-Cited by-同舟云学术

Peak purity assessment in a triple-active fixed-dose combination drug product related substances method using a commercial two-dimensional liquid chromatography system

Published:2014-08-11 Issue:19 Volume:37 Page:2688-2695
ISSN:1615-9306
Container-title:Journal of Separation Science
language:en
Short-container-title:J. Sep. Science

Author:

Shackman Jonathan G.¹,Kleintop Brent L.¹

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

2. Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations

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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