Dissolution Option in Empower: Using the Sample Set Method to create a Sample Set Method for Dissolution - Tip342

OBJECTIVE or GOAL

Use the wizard to create a sample set method with the Dissolution option, selecting Dissolution (Bath A).

ENVIRONMENT

• Empower
• Empower Tip of the Week #342

PROCEDURE

STEP 1
When launching the Sample Set Method Wizard, on the Select Sample Set Method Type screen, select the LC and Dissolution (Bath A) options. Select 2690D/2695D installed if you are using the Alliance 2690D or Alliance 2695D as your autosampler. Click Next (Figure 1).

STEP 2
When you get to the Bath A: Setup screen, specify the range of vessels to use in this bath (for example, if there are six vessels, specify 1-6). Give a descriptive name for the dissolution media (for example, Dilute HCL). Specify the initial volume of media in each vessel, in mL. Click Next (Figure 2).

STEP 3
On the Bath A: Transfer screen, Enter the volume removed on each transfer, in mL. (Removed Volume). Enter the volume of media replaced on each transfer, in mL. (Replaced Volume). In this example, we are not replacing the media. Click Next (Figure 3).

STEP 4
On the Bath A: Samples screen, Enter the position of the first vial. This is the vial position of the first dissolution sample of the first vessel during the first time point being tested. Make sure to allot vial positions for the standards you may have injected before these dissolution samples. In the Dissolution Transfer Times table, specify the times at which to transfer the samples. This time is in minutes and must coincide with the actual time the samples are transferred, whether the transfer is performed automatically or not. Enter the total duration of the dissolution test, in minutes. Select the check box Perform Infinity Test if you want to perform an infinity test, and then specify the time for the infinity test, in minutes. Click Next (Figure 4).

STEP 5
On the Bath A: Components screen, select the Method Set to be used. This Method Set requires both the instrument method and processing method (with the component name) defined. Select the dissolution final report method to be used. Then, in the table below, specify the Dissolution Component Name that matches the component name in the processing method defined in the method set selected above. For each component defined, give the Dissolution Claimed Amount as the label claim of the product being tested. For each component defined, specify the Dissolution Q Factor Minutes. For each component defined, give the Dissolution Q Factor Percent. See the Empower online Help for more information on Q Factor. Click Next (Figure 5).

STEP 6
On the Bath A: Operation screen, specify the bath temperature, in ⁰C. Enter the apparatus speed, in RPM. Click Next (Figure 6).

STEP 7
On the Bath A: Sample Info screen, Enter the Number of samples, Number of injections per vial, Injection volume, and Run Time. Click Next (Figure 7).

STEP 8
After you finish all the rest of the screens in the Sample Set Method wizard, you can save and use the completed Sample Set Method. (Figure 8 shows an example.)

STEP 9
You can edit the dissolution parameters you selected by selecting Edit > Dissolution. Select the tab that you want to edit (Figure 9).

ADDITIONAL INFORMATION

This can be done via the Pro or QuickStart interface.