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    DryLab®4 Software for HPLC method development from Molnár-Institute

    products-servicesMolnár-Institute for applied chromatography
    November 9th 2017

    Molnar-Institute has developed the proprietary software suite, DryLab®4 as a state-of-the-art tool to support analytical scientists in UHPLC method development, optimization, troubleshooting, robustness testing, training and regulatory work.

    DryLab®4 is revolutionary HPLC method development and optimization software that predicts chromatograms under a much wider range of experimental conditions than would ever be possible in the laboratory.

    HPLC researchers can use DryLab®4 to determine quickly and easily exactly how separations behave as they simultaneously vary multiple method parameters, such as pH, temperature, buffer concentration, ternary eluent composition (tc).

    DryLab®4 thus offers considerable speed, efficiency and cost advantages to any organization developing HPLC methods that wish to separate complex samples.

    HPLC Method DevelopmentM

    DryLab®4 predicts critical resolution and retention times for millions of unique, virtual chromatograms, using data generated by only a small number of input experiments.

    The researcher can define analytical target profiles (ATP) and then rely on DryLab®4 to generate model chromatograms.

    After running the required input experiments, uploading them as *.cdf files, which are the universal format for chromatographic data transfer, DryLab®4 offers a number of user-friendly features to help manage input runs, streamline peak tracking, and control for errors.

    Following input runs you can use DryLab®4 to generate a matched peak table, ready to build the HPLC model.

    Based on a unique initial Design of Experiment (DoE), DryLab®4 will create multi-dimensional critical resolution models that depict the set of conditions to achieve an adequate separation. Predicted chromatograms are viewable for any point within the model. A single mouse click can select the working point with the highest critical resolution. DryLab®4 predicts peak widths and retention times with greater than 99% accuracy.

    Advanced functions

    DryLab®4 allows the researcher to predict how changes in additional method parameters will affect the separation, such as flow rate, column dimensions, instrument parameters, and eluent in gradient and in isocratic conditions. This provides maximum flexibility for method optimization and method transfer.

    Once the initial working point is selected, DryLab®4 can test the separation’s tolerance limits by evaluating the impact of small fluctuations on up to six critical separation parameters. This allows researcher to determine which parameters exert the greatest influence on the method and therefore must be strictly controlled to achieve complete success in routine applications.

    Finally, the researcher can create GMP compatible Method Document, a comprehensive Knowledge Management report that contains all method data directly from DryLab®4 to provide a platform from which to justify and comment on method criteria and choices. This report is GMP compliant and the perfect tool for better knowledge sharing.

    DryLab®4 uses real data to create color-coded maps plotting critical resolution as a function of several method parameters. In addition to visualizing the interaction of these parameters, it can also predict chromatograms for changes in other method conditions, such as column dimensions, flow rate, gradient elution, instrument parameters, etc. Each point within the map corresponds to a unique chromatogram, displayed directly below the resolution map, with resolution changes displayed in real time as method parameters are modified. Many reversed phase DoE’ modes are possible, with models which are built based on variable parameters, such as:

    • Gradient Time
    • Temperature
    • pH
    • Ternary Eluent Composition, tc
    • Isocratic %B
    • Ionic Strength (buffer concentration)
    • Additive Concentration (ion-pairing)
    • gradient steps, etc.

    Additional Features & Modules

    In addition, DryLab®4 includes a number of advanced functions to increase the value of HPLC models.

    • Peak Tracking: Identification and assignment of peaks from a set of systematic experiments is an important first step in controlling the HPLC method development process. DryLab®4’s peak tracking feature includes both peak areas and molecular masses, and offers an efficient tool for preparing an organized and systematic color-coded peak table within which researchers can reorder and turn peak positions, separate double and triple peaks, and reduce complexity. The Comparison Feature checks original experimental runs against your DryLab®4 model to control for errors.
    • Gradient Editor: This powerful tool optimizes method in gradient elution, modifying gradient time, changing start- and end- %B, and adding gradient steps. This process can either be controlled manually or rely on DryLab®4 to find the best linear or step gradient automatically. This can significantly reduce run times, but can also dramatically increase resolution between peak pairs.
    • ColumnMatch: This tool provides comparison between different columns, taking into account contributions such as hydrophobicity, steric selectivity, hydrogen-bond-acidity, hydrogen-bond-basicity, and ion-exchange properties of the silica at different pH-values. Selecting columns that are very different in their selectivities can reveal hidden peaks.
    • 3D Cube Module: DryLab®4’s Cube extends the 2D resolution map into the third dimension, providing a Method Operable Design Region (MODR) comprised of three parameters in which researcher can visualize multifactorial variabilities for robust HPLC conditions. In addition, it can model a large number of other parameters, including column dimensions, flow rate, gradient points, and instrument parameters. The Cube generates exponentially more conditions in which to model a method, and offers an intuitive display of how simultaneous changes to multiple method parameters affect the critical resolution and selectivity of separation. A special view shows the 3D regions that fulfill your given resolution requirement (for example, baseline separation of all peaks). You can scroll through the cube to see what the chromatogram looks like for any set of conditions within the 3D region (see video link below).
    • Robustness Module: This module is testing the tolerance limits of a selected working point by computing the number of Out-of-Specification (OoS)- results that occur by small fluctuations in method parameters, evaluating variable conditions such as gradient time, temperature, pH or ternary composition, flow rate and start/end points of the gradient.
    • DryLab®4 Knowledge Management Module: This is a reporting tool for documenting and archiving methods. It encourages a Quality by Design (QbD) approach to method development and ensures that the method conforms to standards by providing a comprehensive method report, including a platform for the step-by-step justification of method choices, with automatically generated Analytical Method Summary for sign off. This assists laboratories to achieve excellent GMP compliance, along with easier and more effective collaboration between departments, supporting analytical method transfer during development, manufacturing and communication with regulatory agencies (FDA, etc.)

    Resources

    Click on DryLab®4 simulation to see video.

    TRENDING WHITE PAPER

    Analytical Method Development: Workflow, Advantages and Future developments

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    DryLab®4 Software for HPLC method development from Molnár-Institute

    Using DryLab®4 to shape initial Design of Experiment (DoE)

    DryLab®4 Software for HPLC method development from Molnár-Institute

    DryLab®4 peak tracking from input experiments

    DryLab®4 Software for HPLC method development from Molnár-Institute

    Screen shot of 3D DryLab®4 HPLC Model

    DryLab®4 Software for HPLC method development from Molnár-Institute

    DryLab®4 Knowledge Management Module generates comprehensive cGMP method report

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