Continuous screening of analytical parameters facilitates efficient development of HPLC methods required for impurity profiling-Reference-Cited by-同舟云学术

Continuous screening of analytical parameters facilitates efficient development of HPLC methods required for impurity profiling

Published:2017-07-03 Issue:11 Volume:40 Page:564-575
ISSN:1082-6076
Container-title:Journal of Liquid Chromatography & Related Technologies
language:en
Short-container-title:Journal of Liquid Chromatography & Related Technologies

Author:

Furukawa Shuntaro¹²,Hirakura Yutaka¹,Moribe Kunikazu²

Affiliation:

1. Analytical Research Laboratories, Astellas Pharma Inc., Ibaraki, Japan

2. Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Pharmaceutical Science,Biochemistry,Analytical Chemistry

Link

https://www.tandfonline.com/doi/pdf/10.1080/10826076.2017.1334214

Reference19 articles.

1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline: Impurities in New Drug Substances Q3A(R2), step 5, http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html, 2006.

2. Development of a purity control strategy for pemetrexed disodium and validation of associated analytical methodology

3. REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT IN AN ANALYTICAL QUALITY BY DESIGN FRAMEWORK

4. Efficient HPLC method development using structure-based database search, physico-chemical prediction and chromatographic simulation

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