Waters Corporation

Application Notebook highlighting Liquid Chromatography techniques commonly used for monitoring Critical Quality Attributes (CQAs) in Bioprocessing Applications

Webinar Dates/Times: Thursday, December 11th, 2024 at 11:00 AM EST

Level up your Empower data with in-depth dashboards and powerful custom data analytics. waters_connect Data Intelligence Software provides real-time, in-depth dashboards and powerful, purpose-built analytics on your Empower Software data to reduce risk, save money, improve productivity, and accelerate time- to-market.

Discover how you can simplify the audit preparation process with data integrity dashboards that provide transparency to key actions, and seamlessly track long-term trends and patterns, helping to prevent system suitability failures before they occur with waters_connect Data Intelligence software.

This application note examines the selectivity differences between three L1 columns. The CORTECS Premier C18, CORTECS Premier C18+ and CORTECS Premier T3 Columns were used to separated paracetamol and its impurities using EP monograph conditions.

In this application note, a USP monograph is modernized to a shorter column using 5 µm particles, which can be allowable under USP <621> as long as the N value is within the guidelines. By using highly efficient CORTECS 5 μm particles, this type of modernization is possible and reductions in solvent usage and run times are achieved.

In this work the development of two key attributes of the 5um CORTECS Columns is examined. First column efficiency is compared across CORTECS and other solid-core 5 μm columns. Next scalability from sub-2 μm to 5 μm particles is examined between the CORTECS Column lines and competitive column lines. It was found that CORTECS columns have higher efficiency compared to other solid-core columns and that CORTECS particles are fully scalable.

Webinar Date/Time: Mon, Oct 21, 2024 11:00 AM EDT

Webinar Date/Time: Wed, Sep 25, 2024 11:00 AM EDT

Webinar Date/Time: Thu, Sep 5, 2024 11:00 AM EDT

HPLC method development of structurally similar components is an arduous task to undertake. Understanding the principles of liquid chromatography and applying them in a structured, streamlined approach not only speeds up the method development process but also provides traceability for the activity in an easy-to-follow format. Having a structured protocol for method development also allows novice users to develop methods independently, without the oversight of expert chromatographers. This app note shows fast method development using a structured protocol called the systematic screening protocol. The protocol used to develop the method relies on MaxPeak™ High-Performance Surfaces (HPS) technology, featured in MaxPeak Premier Columns, to mitigate any non-specific adsorption (NSA) seen between the column and the analytes. Employing this column technology, along with the systematic screening protocol, a method was developed which provides good peak shape and complete separation of all eight dyes.

High efficiency columns increase resolution by reducing peak widths. This enables easier peak integration and identification, as the peaks of interest are better separated from each other and from potential background or excipient peaks. There are several ways for an analyst to improve separation efficiency; one being to use columns packed with smaller particle size stationary phases. Another way is to use longer columns. However, a drawback in the use of both options is that they can be limited by the system operating pressure. Another path forward is the use of solid-core or superficially porous particles (SPP), which have been proven to improve efficiency without sacrificing operating pressure. This app note shows incremental steps on how to improve separation efficiency for a mixture of three analytes.

HPLC method development is not without its challenges. What happens when your favorite column struggles to achieve your peak shape, sensitivity, or reproducibility goals? Whether you’re developing or transferring methods, quickly achieve consistent results with MaxPeak Premier Columns. Available from sub-2 µm to 5 µm HPLC particle sizes, fully porous and solid-core, you can choose the column configuration that meets your needs and eliminate doubt from your chromatographic separations. Find MaxPeak Premier app notes, videos and more at waters.com/tothemax.

HPLC is a versatile and widely used method for analyzing various compounds, particularly in the pharmaceutical industry. It's preferred by generic pharmaceutical companies and quality control groups due to its accessibility compared to newer technologies like Ultra-Performance Liquid Chromatography (UPLC™). In recent years, there has been a growing emphasis on making analytical chemistry techniques, such as HPLC, more sustainable. These "green" initiatives aim to reduce the use of toxic reagents, minimize waste, and lower energy consumption, all while maintaining high scientific standards. This app note highlights Development of a new, greener HPLC method for rivaroxaban and impurities, aligned with the USP monograph and using the Analytical Method Greenness Score (AMGS).

High Performance Liquid Chromatography (HPLC) has been a staple in analytical laboratories for several years. The utility of this technique is such that it can be used to analyze a wide variety of analytes. HPLC allows a lower cost alternative compared to UHPLC instruments, which boast higher performance for the higher capital investment. HPLC systems are still used regularly in the pharmaceutical industry for QA and QC type work such as batch release testing and method development.

When scaling an established analytical method across columns packed with different particle sizes and different column configurations (internal diameters and lengths), the amount of time that is required outside of the lab to produce the equivalent method conditions is considerable. When dealing with a gradient method, the calculations required include determining the new flow rate, gradient times, and injection volume. An analyst can perform these calculations manually using the appropriate equations or tools like the Waters Columns Calculator. This app note examines two scaling workflows by first performing a theoretical scale-down experiment manually using the appropriate method scaling equations, and then repeating the experiment using the scaled-down conditions generated by the Waters Columns Calculator. Strong agreement between manual calculations and the results using the Waters Columns Calculator validate the Waters Column Calculator for its use in scaling methods effectively, with a significant improvement in time savings and a reduction in potential calculation errors and/or uncertainties.

Fraser McLeod (VP, General Manager QA/QC, Waters Corporation) goes in depth about Waters' newest HPLC launch.

Webinar Date/Time: Wed, Nov 1, 2023 11:00 AM EDT

Mistakes in the QC lab come in many forms: forgotten samples, incorrect solvent levels, or not verifying correct system performance. These mistakes can lead to repeated procedures and possibly time-consuming investigations, compromising lab productivity and efficiency. When combined, the Alliance iS HPLC System and Empower Software version 3.8.0 provide several new features designed to reduce errors and improve productivity in QC labs. Join Neil Lander and Denise Heyburn as they provide an overview of the top three advanced capabilities unlocked by combining the intuitively simple Alliance iS HPLC System with the latest version of Empower Software.

Mistakes in the QC lab come in many forms: forgotten samples, incorrect solvent levels, or not verifying correct system performance. These mistakes can lead to repeated procedures and possibly time-consuming investigations, compromising lab productivity and efficiency. When combined, the Alliance iS HPLC System and Empower Software version 3.8.0 provide several new features designed to reduce errors and improve productivity in QC labs. Join Neil Lander and Denise Heyburn as they provide an overview of the top three advanced capabilities unlocked by combining the intuitively simple Alliance iS HPLC System with the latest version of Empower Software.

Webinar Date/Time: Mon, Oct 23, 2023 11:00 AM EDT

Webinar Dates/Times: Session 1 (EU): Wednesday, May 17th, 2023 at 2pm BST | 3pm CEST | 9am EDT Session 2 (NA): Wednesday, May 17th, 2023 at 1pm EDT | 10am PDT | 6pm BST Session 3 (APAC): Thursday, May 18th, 2023 at 12pm JST | 11am CST | 11pm EDT

Learn how a single method was developed for simultaneous determination of two active ingredients, replacing several separate methods for the analysis of assays and organic impurities.

Find out how the Alliance iS HPLC System makes method migration more straightforward with usability features that limit analyst error and improve system reliability.

Pharma QC labs face growing demands to do more with less. With capabilities developed specifically for the QC lab, the Alliance iS HPLC System will quickly become your favorite ally.

Learn how to generate quality data that meets the regulatory requirements of the U.S. Pharmacopeia Chapter <621> with the Alliance iS HPLC System.

See how the Alliance iS HPLC System’s tool-free fittings and improved wash function can eliminate volumetric carryover and reduce adsorptive carryover, respectively.

Find out how the Alliance iS HPLC System makes method migration more straightforward with usability features that limit analyst error and improve system reliability.

See how the Alliance iS HPLC System’s tool-free fittings and improved wash function can eliminate volumetric carryover and reduce adsorptive carryover, respectively.