Fusion LC Method Development

Application Notes / Presentations / Articles

Application Notes

Fusion LC Method Development has been in use for a number of years, and customers have successfully applied FMD to develop and optimize LC methods according to QbD guidelines for a wide variety of sample types, including small molecules, peptides, proteins, and nucleotides. Fusion QbD supports a wide range of chromatographic techniques for these samples, including reversed phase, normal phase, ion exchange, HILIC and Chiral separations, and it has never failed to identify an improved method which meets performance requirements.

Below are application notes which demonstrate the power and efficiency of Fusion QbD for chromatographic methods development.

Application Note 001-06

Accelerated, Automated Development of Robust LC Methods within a QbD Framework.
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Application Note 001-07

DOE-based Study of Separation of Organic Acids using HILIC.
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Application Note 001-08

QbD Optimization of an Impurities Method using Peroxide Degraded Ziprasidone.
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Application Note 001-09

Rapid development of an LC method for separating high molecular weight degradants from a biopharmaceutical product using an automated Design of Experiments (DOE) approach.
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Application Note 002-09

Using a Design of Experiments Approach to Develop Fast LC Methods for Automated Scale-up to Preparative Chromatography of Sulfa Drugs.
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Application Note 003-10

A QbD with Design-of-Experiments Approach to the Development of a Chromatographic Method for the Separation of Impurities in Vancomycin.
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Application Note 004-01

A QbD Approach to Stability Indicating Method Development for Linagliptin Drug Product.
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Application Note 004-02

Automated QbD-Based Method Development and Validation of Oxidative Degraded Atorvastatin
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Application Note 005-01

QbD Based UHPLC Method Development with Seamless Method Transfer to HPLC Using Intelligent System Emulation Technology
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Application Note 005-02

QbD Based Development of a Robust Peptide Mapping Method for a Therapeutic Monoclonal Antibody (mAb).
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Application Note 005-03

QbD Based Method Development — Agilent Infinity II UHPLC and ISET Operating Under Empower 3.
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Application Note 005-04

Rapid Development and Validation of a Size Exclusion Chromatography Method Using Fusion QbD.
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Application Note 005-05

Separation of a Critical Pair of N-Glycans using a Quality by Design (QbD) Approach.
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Presentations / Articles

Below are presentations & articles which describe the power and efficiency customers achieve using Fusion QbD.

Journal of Pharmaceutical and Biomedical Analysis

Ultra high-performance liquid chromatography method development for separation of formoterol, budesonide, and related substances using an analytical quality by design approach.
(Volume 193, 30 January 2021)
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ACS Omega 2020

Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles
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S-Matrix Presentation — EAS 2019

Successful Modernization of a USP Monograph Method using Fusion QBD Software resulted in an Optimized LC/MS Method and Eliminated the Need for a Separate GC Method.
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S-Matrix Presentation — EAS 2019

Integrating and Automating the Use of PDA and MS Data in LC and LC/MS Method Development.
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Chromatography Today Article

Integration of MS and UV Data for Peak Tracking in HPLC Method Development.
(February/March 2019 Issue)
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Journal of Separation Science Article

Ultra high performance liquid chromatography method development for separation of omeprazole and related substances on core‐shell columns using a Quality by Design approach.
[Modernization of the USP Monograph method for Omeprazole and related substances using Fusion QbD]
(November 2019 Issue)
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Pharmaceutical Online Article

How To Use QbD Software To Improve An Existing Identification Method.
[Modernization of the USP Monograph method for Human serum albumin (HSA) using Fusion QbD]
(November 2017 Issue)
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Chromicent GmbH Presentation — SFC Congress 2016

Development of an SFC Method for QC of Carbamazepine using Fusion QbD.
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Pfizer Presentation — HPLC 2016

Use of Fusion QbD for Automated Method Screening for Biotherapeutics.
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LCGC North America article

New HPLC Systems and Related Products (Volume 34, Number 4, April 2016, Chromatography Data Systems — Pages 271–272).
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Chromatography Today article

Fusion QbD and the ‘Perfect Storm’ of Technologies Driving QbD-aligned LC Method Development (Published in the August / September 2015 issue of Chromatography Today).
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Journal of Chromatography A

Development and validation of a rapid ultra-high performance liquid chromatography method for the assay of benzalkonium chloride using a quality-by-design approach (Journal of Chromatography A, 1413 (2015) 22–32).
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FDA Presentation — IFPAC 2015

FDA-EMA Collaborative Research on Analytical QbD — Screening and Optimization Designs to Improve Method Performance and Robustness.
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Journal of Liquid Chromatography & Related Technologies

A QbD with Design-of-Experiments Approach for Development of a State-of-the-Art UPLC Purity Method for Carbamazepine.
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Journal of Pharmaceutical and Biomedical Analysis

Improved quality-by-design compliant methodology for method development in reversed-phase liquid chromatography.
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American Pharmaceutical Review article

Newer Developments in HPLC Impacting Pharmaceutical Analysis: A Brief Review. (Published in the May/June 2013 issue of American Pharmaceutical Review, Volume 16 Issue 4)
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Amgen Presentation — AAPS 2012

Evaluation of Fusion QbD system – A QbD Approach to Method Development and Robustness Studies (SEC-LC and CEX-LC).
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Boehringer Ingelheim Presentation — Pittcon 2012

QbD LC Method Development Using FMD Software.
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Journal of Chromatographic Science article

Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities.
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LCGC North America article

A Quality-by-Design Methodology for Rapid LC Method Development, Part III.
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