Waters Alliance HPLC Dissolution System

Why do you need a dissolution test? Currently, laboratory scientists use a dissolution test when testing the performance of a drug. This test is an important quality control tool by simulating the absorption of drugs in the human body, helping to describe the characteristics and release of the active drug, as well as the dissolution of the active drug from the dosage form.
The Waters Alliance HPLC Dissolution System is compatible with a wide range of dissolved water baths with an e2695D separation unit, transfer module, detector, and one or two dissolution water baths. Empower®-based dissolution software enables fully automated operation of dissolution testing with a single keyboard.

Designed for advanced solvent and sample management for dissolution testing
The Alliance HPLC Dissolution System is the industry's first HPLC platform to combine dissolution sample sampling and HPLC analysis. At the heart of the system is the e2695D Separation Unit, whose integrated flow path design optimizes solvent and sample management processes to help users flexibly respond to specific analytical needs.

The system features a low-diffusion design with automatic balancing and can mix up to four eluents, so high-performance columns can be used to get accurate results quickly, even in the most complex formulation analysis. Samples can be processed separately or after mixing according to pharmacopoeia protocols.

Once the sampling time and volume have been set, the method can be run. The transfer module uses a microprocessor-controlled syringe pump array to simultaneously collect the eluted samples from six or eight vessels and transfer them to the e2695D separation unit. Sealed in the sample vial.

Diversified Media Management <br> The system offers a variety of media management options to meet your specific dissolution testing needs. You can use the following features individually or in combination:

Alliance Dissolution Flow Path - The following is the working mechanism: Valve A or B is open, the syringe plunger is automatically lowered, and the sample in the dissolution cup in the water bath A or B is sucked into the syringe. Valve D is then opened (valve A or B is closed), the syringe plunger is raised, and the sample is transferred to the vial or waste cell. If a media change is made, valve C will open and the syringe plunger will lower and transfer the media to the syringe. Finally, valve A or B opens and the media is transferred back into the sample container.

Maximize efficiency
High sample throughput <br> If there are a large number of samples to analyze, multi-water bath sampling can help you achieve the highest analytical efficiency and effective operating cost control. The Alliance Dissolution System collects and processes dissolved samples from up to two baths (six to eight vessels in each bath).

Intuitive and easy-to-use user interface <br>The easy-to-learn dissolution sample setup wizard sets all the parameters of the dissolution test in an easy-to-use, step-by-step manner.

Wide time range plotting <br> Sample collection can be started within the first minute after the dissolution test is initiated; subsequent sample collection can be done from 2 minutes to several hours. The duration of the dissolution test can be extended from 2 minutes to 7200 minutes.

Flexible, flexible platform system for flexibility
The Alliance HPLC Dissolution System is based on the e2695D Separation Unit, which has the same advanced analytical performance as the standard Alliance HPLC system. Therefore, the dissolution system can be used for both dissolution analysis and routine HPLC analysis, eliminating the need to reconfigure or relearn new analytical system operations.

Analytical Technique Selection <br>This system can be used as a common platform for performing dissolution testing with UV and HPLC, making it easy to switch UV and HPLC analyses while analyzing the same sample set without repeating the dissolution test. In addition, both platforms can use common regulatory certification tools and analytical calculations. By comparison, the results of the dissolution curve obtained by analyzing the same sample by HPLC and in-line flow injection UV absorbance were the same.

Detector Selection <br>This system can be used with any inspection technology you need, no matter what you analyze. Waters offers a complete range of detector options that can be used individually or in series to meet your testing sensitivity and comprehensive dissolution analysis requirements. Multi-detection mode will play a significant role in the simultaneous analysis of multiple active ingredients, or in compounds where the biochemical properties of the analytes vary greatly.

By comparison, the results of the dissolution curve obtained by analyzing the same sample by HPLC and in-line flow injection UV absorbance were the same.

When combined with multiple detection techniques, the Alliance HPLC Dissolution System allows all peaks of interest to be observed in one analysis without the need to rerun the sample or reduce sensitivity.

Leverage Analysis Results <br>Waters Software Solutions help you get the most out of your analysis using the Alliance HPLC Dissolution System. The easy-to-use dissolution software integrates seamlessly with Empower software to automatically control the entire dissolution process—from dissolution to sampling, analytical calculations, and final report generation. Its built-in relational database helps you organize, store, and retrieve experimental data quickly and easily, as well as the flexibility to create different search, tracking, filtering, and viewing conditions to increase productivity.

The system design fully meets regulatory requirements. <br> The dissolution software is fully compliant with 21 CFR Part 11. The system stores detailed electronic audit reports with the highest level of security and ensures the highest integrity of all your tests.

Control charts for temperature and instrument speed are plotted in accordance with the limitations of the International Pharmacopoeia and can provide documentation of the tests performed under specified conditions.

Dissolution software can be used with other options such as System Suitability to help you easily record and determine data trends for all relevant method performance parameters. You will receive detailed process descriptions and accurate audit trails on compliance.

Integrated Dissolution Calculation <br>The Dissolution Software automates the calculations related to dissolution, eliminating the need for external spreadsheet software! All equations used to calculate the results have been validated and can be printed and viewed online for independent verification. If you want, you can also use the "Custom Fields" feature to process additional data from the other program.

The dissolution curve was compared online using the FDA's difference factor (f1) and similarity factor (f2) using Custom Fields. These parameters will be reported and stored along with the rest of the test data.

Comprehensive Publication-Level Reports <br>The Dissolution Software provides a variety of reporting features when used in conjunction with Empower software, so you can choose your report format at will. You can list all the information (such as sampling time, media volume, temperature, instrument speed, and other parameters) in a single report, or create a customized report for a specific customer.

According to your needs, the report can be as detailed as possible or very concise. These reports can be stored in a variety of formats and/or electronically.

To download the full application note, please click: http://?cid=511436&lid=1530063