Determination of polymeric impurities in asunaprevir drug substance and product using size exclusion effect of reversed-phase columns-Reference-Cited by-同舟云学术

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Determination of polymeric impurities in asunaprevir drug substance and product using size exclusion effect of reversed-phase columns

Published:2018-03 Issue: Volume:151 Page:200-208
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Huang Zongyun,Hu Yue,Zha Yan,Perrone Robert,Ruan Joan,Fish William P.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference18 articles.

1. Q1A (R2), Stability Testing of New Drug Substances and Products;ICH,2003

2. Q3B (R2), Impurities in New Drug Products;ICH,2006

3. Code of Federal Regulations, Title 21, Section 211, Current Good Manufacturing Practice for Finished Pharmaceuticals;FDA,2012

4. Gel permeation chromatography. I. A new method for molecular weight distribution;Moore;J. Polym. Sci. Part A,1964

5. Molecular weight distribution of linear polymers: detailed analysis from GPC data;Kissin;J. Polym. Sci. Part A,1995

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1. High-molecular weight impurity screening by size-exclusion chromatography on a reversed-phase column;Journal of Pharmaceutical and Biomedical Analysis;2021-03

2. Characterization of High Molecular Weight Multi-Arm Functionalized PEG–Maleimide for Protein Conjugation by Charge-Reduction Mass Spectrometry Coupled to Two-Dimensional Liquid Chromatography;Analytical Chemistry;2020-05-22

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4. Development of simple isocratic HPLC methods for siRNA quantitation in lipid-based nanoparticles;Journal of Pharmaceutical and Biomedical Analysis;2019-08

5. Quinquennial Review of Progress in Degradation Studies and Impurity Profiling: An Instrumental Perspective Statistics;Critical Reviews in Analytical Chemistry;2019-05-21

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