Get Results Immediately!

Dionex introduces version 2.0 of the Extension Pack for Chromeleon^® 6.8 software. This pack, available for a nominal charge, contains Sequence, Query, and Report templates that allow you to quickly and easily perform and report common tests that otherwise can take considerable amounts of time to process. Most tests involve comparing the results to specifications. The templates do this for you automatically and let you know immediately if your tests have passed or failed.

Let Chromeleon software transform your laboratory and increase your analytical efficiency. For more information, contact your local Dionex representative.

View Your GPC / SEC Results in Chromeleon – Immediately!

Until now, a dedicated tool for gel permeation chromatography (GPC) / size exclusion chromatography (SEC) was not available with Chromeleon^® software. Those days are over. Version 2.0 of the Extension Pack provides a solution.

Using the new templates available in the Chromeleon 6.8 Extension Pack, you can now see your GPC results immediately. As soon as the samples are analyzed, the chromatograms are correctly integrated, and the specifications are entered, you can view the final results on screen in a dedicated report.

Creating a printed report also takes just a few moments. Moreover, you can sign the report electronically, or export it to PDF format.

The templates calculate and report the following molecular weight distribution results:

• Molecular weight distribution plot
• Cumulative molecular weight distribution plot
• Molecular weight averages (Mn, Mw, Mz, Mz+1)
• Polydispersity
• Detailed slice report

The templates have been designed for:

• Narrow standard calibration, up to twenty standards
• Linear, quadratic, and cubic calibrations
• Up to three unknown peaks per chromatogram

Gain productivity! Contact your local Dionex representative and order the Extension Pack for Chromeleon 6.8 – free of charge!

View Your Content Uniformity Testing Results in Chromeleon – Immediately!

Content uniformity testing is a typical analysis performed repeatedly in pharmaceutical laboratories, and the samples are often analyzed using chromatography. Gathering the data from different runs and calculating the final results can be time consuming and may involve exporting the data to another software application.

Using the new templates in the Extension Pack for Chromeleon^® 6.8 software, you can now see your results immediately. As soon as the samples are analyzed, the chromatograms are correctly integrated, and the specifications are entered, you can view the results (including Pass/Fail statements) on screen in a dedicated report. If another testing stage is required, you can easily collate all data and generate a unified report.

Creating a printed report also takes just a few moments. Moreover, you can sign the report electronically, or export it to PDF format.

The Content Uniformity templates:

• Conform to the USP (including different dosage forms) and the EP
• Calculate the results for two experimental stages
• Can report results for up to three different components

Gain productivity! Contact your local Dionex representative and order the Extension Pack for Chromeleon 6.8 – free of charge!

View Your Dissolution Testing Results in Chromeleon – Immediately!

Dissolution testing is a typical analysis performed repeatedly in pharmaceutical laboratories, and the samples are often analyzed using chromatography. Calculating the final results can be time consuming and may involve exporting the data to other software, typically to a spreadsheet or a LIMS.

Using the new templates available in the Chromeleon^® 6.8 Expansion Pack, you can now see your results immediately. As soon as the samples are analyzed, the chromatograms are correctly integrated, and the specifications are entered, you can view the final results (including Pass/Fail statements) on screen in a dedicated report. If another testing stage is required, you can easily collate all data and generate a unified report.

Creating a printed report also takes just a few moments. Moreover, you can sign the report electronically, or export it to PDF format.

The Dissolution templates:

• Conform to the USP and the EP rules for Conventional Release Dosage Forms
• Calculate the results for three experimental stages
• Can report results for up to three different components and ten sampling time points

Gain productivity! Contact your local Dionex representative and order the Extension Pack for Chromeleon 6.8 – free of charge!

Substances Testing

Calculating and reporting the results from related substances testing can take as long as 2 hours per sample. With laboratories running thousands of samples per year, there is a clear need to reduce cycle time. The related substances tool in the Chromeleon^® 6.8 Extension Pack provides a reporting template that completely eliminates calculation and reporting time. As soon as chromatograms are integrated correctly and peaks are named, the report automatically calculates related substances results.

The report calculates average RRT and % Area (or amount) for each peak and can handle duplicate or triplicate analyses and up to 100 peaks. It also allows laboratories to:

• Categorize each peak found in the chromatogram (placebo, unknown, etc)
• Apply detection and reporting limits
• Compare the results against specification

Method Validation

Method validation has never been simpler. Just run your normal validation experiments and have the Chromeleon^® software automatically calculate and report your results. The powerful and flexible Chromeleon software can now calculate all validation results as required by the ICH guidelines.

• Specificity
• Linearity
• Range
• Accuracy
• Precision
• Detection Limit
• Quantitation Limit
• Robustness
• System Suitability Testing

As well as calculating your results, Chromeleon software can also compare them against your specifications and immediately let you know if your tests have passed or failed. It can even compare results obtained over long time periods, such as intermediate precision (different analysts, different days, different instruments) and robustness (different analytical conditions).

The short validation time also allows you to consider revalidating existing methods in order to take advantage of the latest HPLC technology. For example, the Dionex UltiMate^® 3000 HPLC allows you to reduce total run times by as much as a factor of 38 times (e.g. 12 minutes to 0.3 minutes). One of the barriers to adopting this time saving technology has been the amount of time it takes to validate new methods. Chromeleon software reduces this barrier by allowing you to revalidate in a matter of days and allows you to change your analytical method to one that can run thousands of samples in less than a day.

Let Chromeleon transform your laboratory and increase you analytical efficiency. For more information, contact your local Dionex representative. Chromeleon Video - Method Validation