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EmpowerDissolution System Software

Quick Start Guide

34 Maple StreetMilford, MA 01757

71500032203, Revision A

NOTICE

The information in this document is subject to change without notice and should not be construed as a commitment by Waters Corporation. Waters Corporation assumes no responsibility for any errors that may appear in this document. This document is believed to be complete and accurate at the time of publication. In no event shall Waters Corporation be liable for incidental or consequential damages in connection with, or arising from, the use of this document.

© 2002 WATERS CORPORATION. PRINTED IN THE UNITED STATES OF AMERICA. ALL RIGHTS RESERVED. THIS DOCUMENT OR PARTS THEREOF MAY NOT BE REPRODUCED IN ANY FORM WITHOUT THE WRITTEN PERMISSION OF THE PUBLISHER.

Alliance, Millennium, and Waters are registered trademarks, and Empower, LAC/E, and SAT/IN are trademarks of Waters Corporation.

All other trademarks or registered trademarks are the sole property of their respective owners.

Table of Contents

Preface ......................................................................................... 5

Chapter 1 Introduction ...................................................................................... 10

1.1 Dissolution System Features ................................................ 10

1.2 Software Features................................................................. 11

1.3 Tutorial Overview................................................................... 12

1.4 Before You Begin................................................................... 12

Chapter 2 Setting Up the Dissolution System .................................................. 14

2.1 Restoring the Dissolution Project.......................................... 14

2.2 Preparing the Dissolution System......................................... 20

2.3 Preparing to Acquire Dissolution Data .................................. 23

Chapter 3 Developing Methods ........................................................................ 25

3.1 Creating an Instrument Method ............................................ 25

3.2 Creating a Method Set .......................................................... 28

3.3 Creating a Processing Method.............................................. 29

3.3.1 Viewing the Default Processing Method .................... 30

3.3.2 Creating a New Processing Method .......................... 31

3.4 Editing the Method Set.......................................................... 35

Table of Contents 3

Chapter 4 Developing and Running a Sample Set Method for Dissolution Testing ............................................................................................ 37

4.1 Viewing the Default Dissolution Sample Set Method ............ 37

4.2 Creating a Dissolution Sample Set Method .......................... 38

4.3 Running a Dissolution Sample Set Method .......................... 47

Chapter 5 Reviewing Results and Generating Reports .................................... 53

5.1 Reviewing Results................................................................. 53

5.1.1 Displaying the Dissolution Results............................. 53

5.2 Generating a Report ............................................................. 55

Table of Contents 4

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Preface

The Empower Dissolution System Software Quick Start Guide describes the basics of how to use the Empower™ software and the Empower Dissolution software option with a Waters Alliance Dissolution System or another dissolution system. Using a standard set of data, this guide leads you through the steps of logging in, acquiring data, developing methods and method sets, reviewing processed data, and printing reports.

Most procedures in this guide are based on use of the Waters Alliance Dissolution System and one Hanson SR8-Plus bath. However, you can use these procedures for reference when using two Hanson SR8-Plus test baths or with other dissolution systems.

Note: If you use a non-Waters dissolution system, you can use the Empower Dissolution software option only to process dissolution test results.

For in-depth explanations of the Empower software theories of data acquisition, peak detection, integration, and quantitation, refer to the Empower Software Data Acquisition and Processing Theory Guide.

This guide is intended for both novice and experienced users of the Waters Alliance Dissolution System and the Empower software.

Organization

This guide contains the following:

Chapter 1 describes the basic functions of the Empower Dissolution Software option and how it works with the Waters Alliance Dissolution System and other dissolution systems.

Chapter 2 describes how to restore the default dissolution project, and make a working copy of the restored project to use in the tutorials.

Chapter 3 describes how to develop a dissolution instrument method, a dissolution method set, and a dissolution processing method using the Empower software.

Chapter 4 describes how to develop a dissolution sample set method to acquire dissolution data and how to run a dissolution test.

Chapter 5 describes how to review dissolution data and preview, edit, and print a dissolution plot and report.

STOPAttention: Before you use the Empower Dissolution software option, become familiar with the procedures for methods development explained in the Empower Help and in thEmpower Software Getting Started Guide. Additionally, if you use the Waters Alliance Dissolution System, become familiar with the procedures in the Waters Alliance Dissolution System Operator’s Guide.

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Related Documentation

Waters Licenses, Warranties, and Support: Provides software license and warranty information, describes training and extended support, and tells how Waters handles shipments, damages, claims, and returns.

Online Documentation

Empower Help: Describes all Empower windows, menus, menu selections, and dialog boxes for the base software and software options. Also includes reference information and procedures for performing all tasks required to use Empower software. Included as part of the Empower software.

Empower Read Me File: Describes product features and enhancements, helpful tips, installation and/or configuration considerations, and changes since the previous version.

Empower LIMS Help: Describes how to use the Empower LIMS Interface to export results and import worklists.

Empower Toolkit Professional Help: Describes how to use the common-object- model, message-based protocol to communicate with the Empower software from a third-party application.

Printed Documentation for Base Product

Empower Software Getting Started Guide: Provides an introduction to the Empower software. Describes the basics of how to use Empower software to acquire data, develop a processing method, review results, and print a report. Also covers basic information for managing projects and configuring systems.

Empower Software Data Acquisition and Processing Theory Guide: Provides theories pertaining to data acquisition, peak detection and integration, and quantitation of sample components.

Empower System Installation and Configuration Guide: Describes Empower software installation, including the stand-alone Personal workstation, Workgroup configuration, and the Enterprise client/server system. Discusses how to configure the computer and chromatographic instruments as part of the Empower System. Also covers the installation, configuration, and use of acquisition servers such as the LAC/E32 module, the busLAC/E™ card, and interface cards used to communicate with serial instruments.

Empower System Upgrade and Configuration Guide: Describes how to add hardware and upgrade the Empower software using an import-and-export upgrade method.

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Empower Software System Administrator’s Guide: Describes how to administer the Empower Enterprise client/server system and Workgroup configuration.

Empower Software Release Notes: Contains last-minute information about the product. Also provides supplementary information about specific Empower software releases.

Printed Documentation for Software Options

Empower System Suitability Quick Reference Guide: Describes the basics of the Empower System Suitability option and describes the equations used by the System Suitability software.

Empower PDA Software Getting Started Guide: Describes the basics of how to use the Empower PDA option to develop a PDA processing method and to review PDA results.

Empower GC Software Getting Started Guide: Describes how to use the Empower GC option to develop a GC processing method and to review GC results.

Empower GPC Software Getting Started Guide: Describes how to use the Empower GPC option to develop a GPC processing method and to review GPC results.

Empower GPCV Software Getting Started Guide: Describes how to use the Empower GPCV option to develop a GPCV processing method and to review GPCV results.

Empower Light Scattering Software Getting Started Guide: Describes how to use the Empower Light Scattering option to develop a light scattering processing method and to review light scattering results.

Empower ZQ Mass Detector Software Getting Started Guide: Describes installation, configuration, calibration, and tuning methods, as well as how to operate the ZQ Mass Detector with Empower software.

Empower Chromatographic Pattern Matching Software Getting Started Guide: Describes how to use the Chromatographic Pattern Matching option to develop a pattern matching processing method and to review pattern matching results.

Empower Dissolution System Software Quick Start Guide: Describes how to operate the Alliance® Dissolution System using Empower software.

Empower Toolkit Programmer’s Reference Guide: Describes how to use the common-object-model, message-based protocol to communicate with Empower software from a third-party application.

Waters Integrity System Getting Started Guide: Describes features of the Waters Integrity® System and provides step-by-step tutorials that guide a user through the use of the Empower Mass Spectrometry (MS) option.

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Empower AutoArchive Software Installation and Configuration Guide: Describes how to install and configure the Empower AutoArchive option.

Documentation on the Web

Related product information and documentation can be found on the World Wide Web. Our address is http://www.waters.com.

Related Adobe Acrobat Reader Documentation

For detailed information about using Adobe® Acrobat® Reader, see the Adobe Acrobat Reader Online Guide. This guide covers procedures such as viewing, navigating, and printing electronic documentation from Adobe Acrobat Reader.

Printing This Electronic Document

Adobe Acrobat Reader lets you easily print pages, page ranges, or the entire document by selecting File > Print. For optimum print quantity, Waters recommends that you specify a PostScript® printer driver for your printer. Ideally, use a printer that supports 600 dpi print resolution.

Documentation Conventions

The following conventions can be used in this guide:

Convention Usage

Purple Purple text indicates user action such as keys to press, menu selec-tions, and commands. For example, “Click Next to go to the next page.”

Italic Italic indicates information that you supply such as variables. It also indicates emphasis and document titles. For example, “Replace file_name with the actual name of your file.”

Courier Courier indicates examples of source code and system output. For example, “The SVRMGR> prompt appears.”

Courier Bold Courier bold indicates characters that you type or keys you press in examples of source code. For example, “At the LSNRCTL> prompt, enter set password oracle to access Oracle.”

Underlined Blue Indicates hypertext cross-references to a specific chapter, section, subsection, or sidehead. Clicking this topic using the hand symbol brings you to this topic within the document. Right-clicking and selecting Go Back from the shortcut menu returns you to the origi-nating topic. For example, “After you create an instrument method, a processing method, and a method set, you can create a sample set method as described in Section 4.2, Creating a Dissolution Sample Set Method.”

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http://www.waters.com

Notes

Notes call out information that is helpful to the operator. For example:

Note: Record your result before you proceed to the next step.

Attentions

Attentions provide information about preventing damage to the system or equipment. For example:

Cautions

Cautions provide information essential to the safety of the operator. For example:

Keys The word key refers to a computer key on the keypad or keyboard. Screen keys refer to the keys on the instrument located immedi-ately below the screen. For example, “The A/B screen key on the 2414 Detector displays the selected channel.”

… Three periods indicate that more of the same type of item can optionally follow. For example, “You can store filename1, filename2, … in each folder.”

> A right arrow between menu options indicates you should choose each option in sequence. For example, “Select File > Exit” means you should select File from the menu bar, then select Exit from the File menu.

STOPAttention: To avoid damaging the detector flow cell, do not touch the flow cell window.

Caution: To avoid burns, turn off the lamp at least 30 minutes before removing it for replacement or adjustment.

Caution: To avoid electrical shock and injury, turn off the detector and unplug the power cord before performing maintenance procedures.

Caution: To avoid chemical or electrical hazards, observe safe laboratory practices when operating the system.

Convention Usage

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Chapter 1Introduction

This quick start guide describes the basic procedures to set up for a dissolution test. You should be familiar with the operation of the Waters® Alliance® Dissolution System, which consists of:

• A Waters 2690D/2695D Separations Module (6- or 8-needle)

• A Waters Transfer Module (6- or 8-syringe)

• One or two Hanson SR8-Plus baths (optional)

For information on operating the Waters Alliance Dissolution System, refer to the Waters Alliance Dissolution System Operator’s Guide.

If you do not use a Waters Alliance Dissolution System, you can use or adapt the procedures in this guide for your system.

1.1 Dissolution System Features

The Empower Dissolution option is used with the Waters Alliance Dissolution System or with any other HPLC-based dissolution system. When used with the Waters Alliance Dissolution System, the dissolution software option allows you to acquire, process, review, and report dissolution test data. It provides dissolution-specific functions, such as a Compute Dissolution algorithm to calculate the amount and percent dissolved for each component peak, and a Dissolution Wait time so you can specify injection of standards immediately before sample transfers.

For more information on the Empower Dissolution option functions, see the “Dissolution Functions (Samples Table)” topic in the Empower Help.

For more information on dissolution calculations used in the Empower Dissolution option, see the “Compute Dissolution Algorithm” topic in the Empower Help.

If you use one or two Hanson SR8-Plus test baths with the Alliance Dissolution System, the Dissolution software option also controls the bath temperature and apparatus speed, as well as sample transfer, injection, review, report, and processing.

STOPAttention: You cannot perform dissolution testing using a 6-needle 2690D/2695D Separations Module with an 8-syringe transfer module, or vice versa.

Dissolution System Features 10

If you use another generic test bath with the Alliance Dissolution System, Empower Dissolution software controls sample injection, transfer, and processing with acquired data. You cannot import data and process it using Empower software.

Although this guide covers procedures for using the Empower Dissolution software option with the Waters Alliance Dissolution System and one Hanson SR8-Plus bath, you can use or adapt the procedures for other system configurations. For example, if you use:

• A Waters Alliance Dissolution System and two Hanson SR8-Plus baths, the default dissolution project included on the Empower Dissolution software option disk provides a reporting method for a dual-bath system.

• A 2690D/2695D Separations Module, a Waters Transfer Module, and a third-party bath, the Empower Dissolution software option controls only sample transfer, injection, processing, and reporting; it does not control bath temperature and apparatus speed. Bath parameters appear in the dissolution report for documentation purposes only.

• Another Waters autosampler (for example, the 717plus Autosampler), you manually transfer the samples from the test bath to the autosampler. In this case, the Empower Dissolution software option controls only injection, processing, and reporting. Bath parameters appear in the dissolution report for documentation purposes only.

1.2 Software Features

Using the Alliance Dissolution System, the Empower Dissolution software option can:

• Calculate percent dissolved and amount dissolved for each peak identified in the dissolution component table

• Perform F1F2 calculations on results from two sample sets

• Program a Dissolution Wait function so that standards are injected just before samples are transferred

• Be turned on or off for each project or all projects

• Pool samples in the sample loop before injection

• Specify (in a single-bath system) rapid sampling using a minimum (2.5 mL) presample rinse on all but the first sample, reducing sampling times

• Rerun samples without recreating a new sample set method.

• Calculate optimum offset times in a dual-bath system to prevent overlapping transfer times

• Print a summary report of test results using a dissolution report method

• Include multiple Q factor reference points in a dissolution report method

• If you use Hanson baths, include bath temperature and apparatus speed quality control charts in a dissolution report method

Software Features 11

1.3 Tutorial Overview

The tutorials in this guide show you how to use the Empower Dissolution software option to:

• Create a dissolution sample set method

• Run a dissolution sample set method

• Review processed data

• Preview and print a dissolution report

The tutorials in this guide use the default dissolution project, which is on the Empower Dissolution project disk.

1.4 Before You Begin

Note: This guide uses the Empower Pro interface. If you do not have access to this interface, see your system administrator.

Before you perform the procedures in this guide, you need to install:

• The dissolution system as described in the Waters Alliance Dissolution System Operator’s Guide, Chapter 2, Installing the Dissolution System, and in the Alliance Dissolution System Release Notes for firmware version 2.00.

Note: If you operate the Alliance Dissolution System in a regulated environment, install the system according to the procedures in the Waters Alliance Dissolution System Qualification Workbook, Installation Procedures, Part II: IQ (Waters part number 71550010312).

• Empower software as described in the Empower System Installation and Configuration Guide.

• Empower Dissolution software option as described in the Empower System Installation and Configuration Guide.

STOPAttention: Become familiar with the operation of the Empower software before you use the Empower Dissolution option.

Tutorial Overview 12

In addition, be sure to:

• Review and become familiar with the basic operating procedures, including data acquisition, described in the Empower Software Getting Started Guide.

• Become familiar with the operating procedures for the Waters Alliance Dissolution System. See the Waters Alliance Dissolution System Operator’s Guide and the Alliance Dissolution System Release Notes for version 2.00 of the 2690D/2695D firmware for more information.

• Review the information about the Empower Dissolution option in the “Dissolution Overview” topic in the Empower Help.

• Configure your printer correctly.

Before You Begin 13

Chapter 2Setting Up the Dissolution System

This chapter describes how to restore the default dissolution project, and make a working copy of the restored project to use in the tutorials.

The sections that follow describe how to:

• Restore the default dissolution project (Section 2.1, Restoring the Dissolution Project)

• Set up the dissolution system for operation (Section 2.2, Preparing the Dissolution System)

• Set up the Empower software for dissolution testing (Section 2.3, Preparing to Acquire Dissolution Data)

2.1 Restoring the Dissolution Project

After you install the Empower Dissolution software option (see the Empower System Installation and Configuration Guide), you need to:

1. Restore the default dissolution project to the same database location as the Empower software. The default dissolution project (Dissolution_Project), on the Empower Dissolution project disk, contains sample data used in this guide.

2. Make a working copy of the restored project to use for the tutorials in this guide. See the “Making a Working Copy of the Default Dissolution Project” on page 18.

To restore the default dissolution project, you must log in to the Empower software using an account with the Restore Projects privilege. See your system administrator for assistance.

Restoring the Project

To restore the default dissolution project:

1. To start Empower software, select Start > Programs (for Windows XP, All Programs) > Empower > Empower Login. The Empower Login dialog box appears (Figure 2-1).

Restoring the Dissolution Project 14

Figure 2-1 Empower Login Dialog Box

2. Enter your user name and password. If you do not know your user name or password, see your system administrator.

For more information on Empower login procedures, see the “Logging In” topic in the Empower Help.

3. If you are using an Empower Enterprise system, select the correct database from the Database list. This list appears only when you are connected to a client/server system.

4. Click Advanced and verify that the Requested Interface field is set to Pro. If you cannot select the Empower Pro interface, see your system administrator.

5. Click OK. The Empower Pro window appears.

6. Right-click Configure System, then select Projects. Configuration Manager appears (Figure 2-2).

Personal System Workgroup or Enterprise System


Figure 2-2 Configuration Manager Window

7. Click (Restore) (Figure 2-2), or select File > Restore Project, to start the Restore Project wizard (Figure 2-3). The directory specified in the Restore Project Wizard – Start Software page is the default source folder for the project files you are restoring.

8. If this is not the path where you want to restore your project files, click Browse to select the folder where the project you want to restore is located (as shown in Figure 2-3), then click Next.

Note: The path to the directory containing the project files may differ from the one shown in Figure 2-3.

Restore Tool


Figure 2-3 Restore Project Wizard – Start Software Page

For more information on restoring a project, see the “Restoring a Project Using the Wizard” topic in the Empower Help.

9. After completing each page, click Next.

10. Click Finish on the last page. The restored project, Dissolution_Project, appears in the Configuration Manager Projects view pane (Figure 2-4).

To update Configuration Manager, select View > Refresh.


Figure 2-4 Configuration Manager with Restored Dissolution Project

Making a Working Copy of the Default Dissolution Project

A working copy of the default dissolution project allows you to create new methods specific to your system without destroying default methods and data in the original project.

To make a working copy of the restored default dissolution project:

1. In Configuration Manager, select the restored Dissolution_Project (Figure 2-5).

Restored Dissolution Project


Figure 2-5 Configuration Manager with Restored Dissolution Project Row Highlighted

2. Right-click the selected project row, then select Clone. The Clone Project dialog box appears (Figure 2-6).

Figure 2-6 Clone Project Dialog Box


3. Type My_Project in the New project name seed box.

4. Ensure that the # of Copies field is set to 1.

5. Clear the Increment check boxes and delete any numbers or letters from the Prefix and Suffix fields.

6. Type comments (such as “working copy of default dissolution project”) in the Set Project Comments box, then click OK. A progress bar indicates the time remaining for Empower software to clone the project. When the cloning process is complete, the working copy of the default project appears in the Configuration Manager Projects table (Figure 2-7).

Figure 2-7 Configuration Manager Projects Table with Cloned Project Added

7. Select My_Project to select the entire row, then right-click and select Open to open your working copy of the default dissolution project.

You can now view the dissolution data from the default project in your working copy and use it to develop your own methods, as described in Chapter 3.

2.2 Preparing the Dissolution System

STOPAttention: To perform the procedures in this section, you must be familiar with the operation of the Waters Alliance Dissolution System. Refer to the Waters Alliance Dissolution System Operator’s Guide, Chapter 2, Installing the Dissolution System, for more information.

Preparing the Dissolution System 20

Before you can use the Empower Dissolution software option to develop methods, you need to set up the Waters Alliance Dissolution System or another dissolution system.

Setting Up a Waters Alliance Dissolution System

1. Prepare one or two Hanson SR8-Plus baths, according to the procedures in the SR8-Plus Operation Manual (Hanson Research Corp.).

2. Prepare the Uni-Probes (six or eight, depending on the number of vessels in the bath to be used in this dissolution test), according to the instructions in the Uni-Probe Operator’s Manual (Hanson Research Corp.).

3. Prepare the 2690D/2695D Separations Module outlined as follows.

To prepare the 2690D/2695D Separations Module:

1. In the Main screen, press the Config screen key. The Configuration screen appears (Figure 2-8).

Figure 2-8 Configuration Screen

2. In the System section, select Controlled by Empower from the list. For information about other 2690D configuration parameters, see the Waters Alliance Dissolution System Operator’s Guide.

3. In the Configuration screen, press the Dissolution screen key. The Dissolution System Configuration screen appears (Appendix 2-9).


Figure 2-9 Dissolution System Configuration Screen

4. Select an appropriate bath configuration from the Bath type and number of baths drop-down lists.

5. If applicable, check that the number of syringes in the Syringes text box matches the number in the Waters Transfer Module.

6. If you select a single-bath configuration, you can enable the recirculation parameter on the Dissolution System configuration screen for the selected bath.

7. Press the OK screen key to configure the dissolution system.

8. Press the Exit screen key to return to the 2690D/2695D Main screen.

For more information on configuring the 2690D/2695D for Empower control, see the Waters Alliance Dissolution System Operator’s Guide.

Setting Up Other HPLC-Based Dissolution Systems

Prepare another HPLC-based dissolution system according to the instructions in the documentation for the system.

When you use Empower software and the Empower Dissolution option to acquire and process dissolution data with another HPLC-based dissolution system, you must set up a dissolution sample set using the New Sample Set Method wizard (see Section 4.2, Creating a Dissolution Sample Set Method). Otherwise, you cannot obtain dissolution-specific results.


2.3 Preparing to Acquire Dissolution Data

After you have set up the dissolution system hardware, you need to connect the Empower software to the system. Connecting the Empower software to the Alliance Dissolution System hardware involves connecting to:

• An acquisition server

• A chromatographic system

Connecting to an Acquisition Server

Before you can acquire data using the Empower software in a networked or client/server environment, you need to create a new or connect to an existing acquisition server. See your system administrator for assistance.

To connect to an existing acquisition server:

1. In Configuration Manager, select Acquisition Servers from the tree pane.

2. Right-click the name of the acquisition server in the table, then select Properties. Empower software connects to the selected acquisition server. You can view the properties of the selected acquisition server in the Acquisition Server page.

To create a new acquisition server:

1. Right-click Acquisition Servers, then select New > Acquisition Server. The New Acquisition Server wizard appears.

2. Select the Network Node that contains the acquisition server by either:

• Typing the name of the acquisition server in the Acquisition Server Node Name text box

• Clicking the Browse the Network button to display the Select Network Node dialog box

3. Click Finish. The new Acquisition Server is added to the tree pane in Configuration Manager.

For more information, see the “Selecting an Acquisition Server” topic or the “Managing Acquisition Servers” topic in the Empower Help.

Connecting to a Chromatographic System

Before you can acquire data using Empower software in a stand-alone or client/server environment, you need to connect to a chromatographic system. To connect to a chromatographic system:

1. In Configuration Manager, select Systems from the tree pane.

Preparing to Acquire Dissolution Data 23

2. To create a new or connect to an existing chromatographic system, right-click Systems and then select New > Chromatographic System. The New Chromatographic System Wizard – Type Entry page appears.

Note: If you need help on the wizard at any time, click the Help button.

3. In the System Type section, select one of the following:

• Create New System

• Connect to Existing System

4. Make the appropriate selections on each subsequent page, clicking Next to advance through the wizard.

5. When you reach the last page, name the system if necessary, then click Finish.

For more information on creating a new chromatographic system, see the “Creating a New Chromatographic System Using the Wizard” topic in the Empower Help.

For more information on connecting to an existing chromatographic system, see the “New Chromatographic System Wizard – Type Entry Page” topic in the Empower Help.

After you connect to the acquisition server running Empower software and to a chromatographic system, you are ready to create a dissolution instrument method.

Preparing to Acquire Dissolution Data 24

Chapter 3Developing Methods

The procedures in this chapter require that you have:

• Restored the default dissolution project (Section 2.1, Restoring the Dissolution Project)

• Set up the dissolution system (Section 2.2, Preparing the Dissolution System)

• Connected the Empower software to a chromatographic system and acquisition server, if necessary (Section 2.3, Preparing to Acquire Dissolution Data)

Before you can acquire, process, review or print a report of dissolution data, you need to:

• Create an instrument method based on the instruments in your dissolution system (Section 3.1, Creating an Instrument Method).

• Create a method set (Section 3.2, Creating a Method Set).

• Create a processing method (Section 3.3, Creating a Processing Method).

After you complete these methods, you can develop a sample set method for dissolution testing, as described in Chapter 4, Developing and Running a Sample Set Method for Dissolution Testing.

3.1 Creating an Instrument Method

An instrument method is a set of instructions that specify how Empower software acquires data and controls the instruments in the chromatographic system.

In Empower software, you set the control and acquisition parameter values for each instrument in the Instrument Method Editor. You define the instruments in your chromatographic system in Configuration Manager.

Viewing the Default Instrument Method

Before you create an instrument method for dissolution testing, you may want to view an existing instrument method in the default dissolution project. To view the instrument method in the working copy of the default project (“Making a Working Copy of the Default Dissolution Project” on page 18):

1. In Configuration Manager, select My_Project, then right-click and select Open. The Project window appears (Figure 3-1).

Creating an Instrument Method 25

Figure 3-1 Empower Project Window Displaying Default Dissolution Project

2. In the Project window, click the Methods tab.

3. Right-click the default instrument method (Prednisone_Instrument_Method), then select Open. The Instrument Method Editor opens, displaying the parameters for the selected instrument method (Figure 3-2).


Figure 3-2 Instrument Method Editor for Default Instrument Method

4. View the instrument method parameters by clicking:

a. The image button of each instrument in the method (2690D/95D and 2487)

b. The property tabs for each instrument (2690D/95D and 2487)

Creating a New Instrument Method

Note: If you use a detector other than the Waters 2487 Dual λ Absorbance Detector, contact your Waters service representative for the procedures to set up an instrument method.

To create a new instrument method:

1. In the Instrument Method Editor, select Edit > Add Instrument. The Add Instrument dialog box appears.

Instrument Method

Editor Tabs

2690D/95DImage

2487Image


2. Select an instrument from the Instrument Type dialog box and click OK. The instrument you added will appear as an icon in the Instrument Method Editor window.

3. In the General, Degas, Events, Flow, Temperature, Solvents, and Channel tabs, enter parameter values, making the changes specific to the system you use for dissolution testing.

4. When you enter parameter values, select File > Save. The Save current Instrument Method dialog box appears.

5. Enter a name for the instrument method and optional comments, then click OK.

6. Select File > Exit to close the Instrument Method Editor.

You can also use the New Method Set wizard to create a new instrument method. For more information, see the Empower Software Getting Started Guide, Section 4.3, “Creating a Method Set”.

3.2 Creating a Method Set

A method set is a set of instructions that specify how to acquire, process, and report data. A method set allows you to link instrument, processing, report, and/or export methods to perform specific operations in the Empower software.

For example, a method set allows you to:

• Select individual methods to use during data acquisition, data processing, and/or reporting

• Select the processing and reporting methods used to process and report individual channels of an injection

• Create derived channels from channels of 2D or 3D data

Viewing the Default Method Set

Before you create a method set for dissolution testing, you may want to view an existing method set in the default dissolution project. To view the method set in the working copy of the default project (that you created in Section 2.1, Restoring the Dissolution Project):

1. In Configuration Manager, select My_Project, then right-click and select Open. The Project window appears (Figure 3-1).


STOPAttention: Ensure the dissolution system you use is configured with the instruments you add at this time.

Creating a Method Set 28

3. Right-click the default method set (Prednisone_Method_Set), then select Open. The Method Set Editor opens, displaying the parameters for the selected method set. The instrument and processing method are included in the method set.

4. Select File > Exit to close the Method Set Editor.

Creating a New Method Set

To create a new method set using the default method set:

1. Access the Prednisone_Method_Set from My_Project as instructed above in “Viewing the Default Method Set”. The Method Set Editor displays the default Instrument and Processing methods for the default method set.

2. Select File > New. The Method Set Editor dialog box appears and asks if you want to use the wizard to create this new method set.

3. Click Yes. The New Method Set: Select an Instrument Method dialog box appears.

4. Select the instrument method you created in “Creating a New Instrument Method” on page 27.

5. Click Next. The Select Default Methods page appears.

6. At this time, do not select a processing or reporting method.

7. Click Next. The Name Method Set page appears.

8. Enter a name for the new method set, enter optional comments, then click Finish. The Method Set Editor reappears.

9. Select File > Exit to close the Method Set Editor.

For more information on creating a method set using the New Method Set wizard, see the Empower Software Getting Started Guide, Chapter 4, Developing Methods, or the “What Is a Method Set?” and “Accessing the Method Set Editor” topics in the Empower Help.

3.3 Creating a Processing Method

A processing method is a set of instructions that specify how Empower software processes data from the detector channel. A processing method allows you to:

• Integrate peaks by determining the start and end of each peak

• Calibrate standards and generate calibration curves for the components being analyzed

• Define amounts or concentrations for the components being calibrated

• Quantitate unknown samples (or QC control samples) and generate results

• Group components for analysis

• Calculate detector noise and drift

Creating a Processing Method 29

3.3.1 Viewing the Default Processing Method

Before you create a processing method for dissolution testing, you may want to view an existing processing method in the default dissolution project. To view the method set in the working copy of the default project (that you created in Section 2.1, Restoring the Dissolution Project):

1. In Configuration Manager, right-click My_Project, then select Open. The Project window appears (Figure 3-1).


3. Right-click the default processing method (Prednisone PM), then select Open. The LC Processing Method window opens with the processing method parameter values (Figure 3-3).

Figure 3-3 LC Processing Method Window

4. Use the Processing View table tabs to view the processing method parameters.

For more information on processing methods, see the “What Is a Processing Method?” topic in the Empower Help.


3.3.2 Creating a New Processing Method

You can create a new processing method in several ways. This guide provides the procedure for creating a new processing method using unprocessed data from a single injection of a known standard.

Making a Single Injection Run of a Known Standard

To create a new processing method using unprocessed data, you need to:

• Run a single injection of a known standard

• Use the data from the single injection to develop a processing method

Note: The default processing method uses a prednisone standard, but you can use any known laboratory standard to create a processing method from a single-injection run.

Before You Begin

Prime the dissolution system. For more information, refer to the Waters Alliance Dissolution System Operator’s Guide or the operator’s guide for the system in use.

Required Materials

• Any reference standard appropriate to the dissolution system

• One standard 2-mL vial with screw-neck, opaque cap, and preslit septum

Procedure

To run a single injection of a known standard:

1. Fill the 2-mL vial with dissolved standard, then place it in Position 100 in the 2690D/2695D sample carousel.

2. From the Project window, select Tools > Run Samples. Select the desired chromatographic system. The Run Samples window appears (Figure 3-4).


Figure 3-4 Run Samples Window

3. Click the Single tab (at the bottom of the window).

4. From the Instrument Method drop-down list (at the bottom of the window), select the instrument method you created in Section 3.1, Creating an Instrument Method, then click Setup. Allow the system to equilibrate.

Note: When the dissolution system is under Empower Run Samples control, you cannot access functions from the 2690D/2695D front panel. If Empower software encounters an error during equilibration, abort the run, then select File > Exit. After a short delay, front panel control of the 2690D/2695D is reestablished.

5. Enter data in the following fields:

a. From the Run Mode field, select Run Only from the list at the top left of the window.

b. In the Sample Name field, type an appropriate name.

c. From the Function list, select Inject Standards.

d. From the Method Set list, select the name of the method set you created in Section 3.2, Creating a Method Set.

e. In the Vial field, type 100.

f. In the Injection Volume field, type an appropriate injection volume.

g. In the Run Time field, type an appropriate run time.

6. Click (Single Inject) to run the standard.


7. When the standard injection is complete, select File > Exit.

Now you can use the data acquired from the single injection of the standard to create a new processing method.

Creating a New Processing Method from Single Injection Data

To create a processing method after you make the single injection run of the standard:

1. In the Project window (Figure 3-1), click the Injections tab.

2. Select the name of the injection from step 5d of the “Making a Single Injection Run of a Known Standard” discussionAppendix Appendix , then right-click Review. The Review Main window appears (Figure 3-5).

Figure 3-5 Review Main Window

3. Select File > New > Processing Method. The New Processing Method dialog box appears (Figure 3-6).

Figure 3-6 New Processing Method Dialog Box


4. From the Processing Type list, select LC.

5. Select the Use Processing Method Wizard check box, then click OK. The Integration – Integration Region page of the Processing Method wizard appears (Figure 3-7).

Figure 3-7 Integration – Integration Region Page of the Processing Method Wizard

6. Use your mouse to zoom in on the peak. (Zooming inhibits integration outside the zoomed area.) Empower software calculates the start and end times for the zoomed (peak) area. When you are satisfied with the selected peak area, click Next. The Peak Width and Threshold page appears, displaying the peak start and end values and the peak area you selected when you zoomed the peak.

7. Click Next. The Peak Rejection page appears. If you are not satisfied with the peak area you selected, click the Back button and repeat step 6.

8. If you are satisfied with the peak area selected, click Next. The Calibration – General page appears.

9. In the Calibration – General page, select the following values:

• Area for method of quantitation

• Amount for component information

• Linear for calibration curve type

Note: For the Empower Dissolution software to calculate results accurately, you must select Amount for the component information parameter in the Calibration – General page.

Click Next. The Calibration – Names and Retention Times page appears.


10. In the Name column, enter the component name for each peak of interest. The Calibration – Default Amounts page appears.

11. Leave the Calibration – Default Amounts table blank, then click Next. The Calibration – Internal Standards page appears.

12. Click External Standard Calibration, then click Next. The Processing Method Name page appears.

13. Enter a name for your processing method, enter comments (optional), then click Finish. The Review Main window appears displaying with the peak(s) with the name(s) you defined in the Components table.

14. Select File > Exit to return to the Project window.

For more information on ways to create or modify a processing method, see the “Methods of Developing and Modifying a Processing Method” topic in the Empower Help.

For a tutorial on developing instrument and processing methods and method sets, refer to the Empower Software Getting Started Guide, Chapter 4, Developing Methods.

3.4 Editing the Method Set

After you create the processing method, you need to add the new processing method to the method set you created in Section 3.2, Creating a Method Set.

To edit the method set:

1. In the Project window, click the Methods tab, then select the method set you created in Section 3.2, Creating a Method Set.

2. Right-click the method set, then select Open to open the method set. The Method Set Editor appears (Figure 3-8).

Figure 3-8 Method Set Editor

Editing the Method Set 35

3. Ensure that the instrument method you created in Section 3.1, Creating an Instrument Method, appears in the Instrument Method field.

4. From the Default Processing Method list, select the processing method you created in Section 3.3.2, Creating a New Processing Method.

5. Do not enter a Default Report Method at this time.

6. Select File > Save to save the edited method set. Select File > Exit to close the Method Set Editor.

The method set, which now contains an instrument method and a processing method, is ready to be used in a dissolution sample set method.

Editing the Method Set 36

Chapter 4Developing and Running a Sample Set Method for Dissolution Testing

A sample set method is a set of instructions that specifies how and when to acquire data from each vial (standard or unknown) in a set of vials. In addition to the usual LC system functions, a dissolution sample set method provides instructions for transferring samples (usually of a known aliquot) from one or two test baths to an autosampler.

To create a dissolution sample set method or template, you must use the New Sample Set Method wizard. You cannot create a dissolution sample set method or template by using the Samples table (in Run Samples) or the Sample Set Method Editor (in the Project window).

After you run a dissolution sample set method, the system calculates the amount and percent dissolved for each peak based on the components listed in the components table and generates a results set. You can track and summarize dissolution test results as a group using the Empower software Project view. You can also review and print dissolution test results using Review and Report Publisher (see Chapter 5, Reviewing Results and Generating Reports, for more information).

For more information on the dissolution calculations, see the “Compute Dissolution Algorithm” topic in the Empower Help.

4.1 Viewing the Default Dissolution Sample Set Method

Note: To restore the default dissolution project from the Empower options disk, see Section 2.1, Restoring the Dissolution Project.

Before you create a dissolution sample set method, you may want to view an existing sample set method. To view the sample set method in the working copy of the default project that you created in Section 2.1, Restoring the Dissolution Project:

1. In Configuration Manager, select My_Project, then right-click and select Open. The Project window appears with the default dissolution project selected (Figure 3-1).

Viewing the Default Dissolution Sample Set Method 37

2. In the Project window, click the Methods tab, right-click PrednisoneUSP 10mg (the default sample set method), then select Open. The Sample Set Method Editor opens, displaying the parameter values for the selected sample set method (Figure 4-1).

Figure 4-1 Sample Set Method Editor

3. Scroll through the sample set method to become familiar with the Sample Set Method Editor.

4. Select File > Exit to close the Sample Set Method Editor and return to the Project window.

4.2 Creating a Dissolution Sample Set Method

After you create an instrument method, a processing method, and a method set, you can create a sample set method. This section provides procedures to create a dissolution sample set method.

Creating a Dissolution Sample Set Method 38

Before You Begin

Before you create a new sample set method, make sure you have:

• Restored the default dissolution project (Section 2.1, Restoring the Dissolution Project)

• Set up the dissolution system for testing (Section 2.2, Preparing the Dissolution System)

• Set up the Empower software to acquire dissolution data (Section 2.3, Preparing to Acquire Dissolution Data)

• Created an instrument method (Section 3.1, Creating an Instrument Method)

• Created a method set (Section 3.2, Creating a Method Set), then edited the method set (Section 3.4, Editing the Method Set)

• Created a new processing method by using the results of unprocessed data from a standard injection (Section 3.3.2, Creating a New Processing Method)

Procedure

To create a sample set method:

1. In Configuration Manager, select My_Project, then right-click and select Open. The Project window appears with your project.

2. In the Project window, select File > New Method > Sample Set Method. The New Sample Set Method wizard appears.

3. For this example, select Create sample set method using this wizard, then click Next. The Select Sample Set Method Type page appears (Figure 4-2).

Figure 4-2 Select Sample Set Method Type Wizard Page


4. Make the following selections (Figure 4-2), then click Next. The Select Location of Standards wizard page appears.

• LC or PDA/MS for the type of sample set method.

• Dissolution (Bath A) for the dissolution type.

• If you use a Waters Alliance Dissolution System, select either 6 Syringes or 8 Syringes, depending on the configuration of the Waters Transfer Module.

• If you do not use a Waters Alliance Dissolution System, clear the 2690D/2695D installed check box.

5. For this method, select Before each sample group. In the Starting loading vials in tray position field, enter 100, then click Next. The Specify Calibration Options page appears.

6. Select a Standard Levels option to define your calibration method: either each vial contains a different level standard, or an autosampler or autoinjector makes injections of varying volumes from a standard vial. Click Next. The Describe Standard Bracket page appears.

7. Enter values appropriate for your method. For more information, click Help.

In the Method Set field, select the method set you created in Section 3.2, Creating a Method Set, then click Next. The Bath A: Setup page appears (Figure 4-3).

Figure 4-3 Bath A: Setup Wizard Page

STOPAttention: To avoid sample transfer errors, ensure you enter dissolution system configuration information accurately in the Select Sample Set Method Type page.


8. In the Enter the range of vessels to use in this bath field, enter vessel numbers or ranges separated by commas. For example: 1–6, or 1–8, or 1,2,5–8

Note: The vessels you define refer to vessels corresponding to vials designated for LC analysis.

9. Enter a description of the dissolution media and the initial volume of media in each dissolution vessel (Figure 4-3).

10. If your media is viscous, select Slow for the Syringe speed, otherwise select Normal.

11. If you want to rinse the waste line, enter a value of 0 to 7.5 mL for a post sample wash. Click Next. The Bath A: Transfer page appears (Figure 4-4).

Note: Post sample wash affects sample timing.

Figure 4-4 Bath A: Transfer Wizard Page

12. Enter appropriate parameter values in the Bath A: Transfer page (Figure 4-4).

Recirculate Media is an option for single-bath systems only. If you select Recirculate Media in this page, ensure that you select Recirculate media to vessels in the Dissolution System Configuration screen (Figure 2-9) on the front panel of the 2690D/2695D.

For information on the Replace Media, Rapid Sampling, and Recirculate Media parameters in this page, click Help, or see the Waters Alliance Dissolution System Operator’s Guide, Sections 3.2.4 and 4.1.1. Click Next. The Bath A: Samples page appears (Figure 4-5).


Figure 4-5 Bath A: Samples Wizard Page

13. Enter appropriate parameter values in the Bath A: Samples page (Figure 4-5). For information about the Perform Infinity Test or Collect All Samples Before Any LC check boxes in this page, click Help. Click Next. The Bath A: Components page appears (Figure 4-6).

Figure 4-6 Bath A: Components Wizard Page


14. In the Method Set section, select the method set you created in Section 3.2, Creating a Method Set.

Select Dissolution from the Select the dissolution final report method drop-down list.

Complete the Components table:

a. Select one or more components of interest from the Name drop-down list.

b. Enter an appropriate claimed amount in the Claimed Amount field for each selected component.

c. For each selected component, select an appropriate Q factor from the Q Factor Minutes drop-down list.

d. For each selected component, enter an appropriate Q factor percentage in the Q Factor % field.

Click Next. The Bath A: Operation page appears (Figure 4-7).

Figure 4-7 Bath A: Operation Wizard Page

15. Check that the bath temperature and apparatus speed parameter values are as shown in Figure 4-7, or are appropriate for your method. For information about the Out of USP Tolerance Alarm and the Automatic Printout check boxes in this page, click Help.

Note: If you use the Hanson SR8-Plus bath, the temperature and apparatus speed parameter values entered in this page control the bath. If you use a non-Hanson bath, these parameter values are for documentation purposes only.


Select and enter the remaining operation parameter values you want, then click Next. The Bath A: Pooling page appears (Figure 4-8).

Figure 4-8 Bath A: Pooling Wizard Page

16. If you want to pool samples, select the Pool Injections check box. For information about the Bath A: Pooling page parameters, click Help. Click Next. The Sample Info page appears (Figure 4-9).

Figure 4-9 Bath A: Sample Info Wizard Page


17. For information about the Bath A: Sample Info page parameters, click Help. Enter values appropriate for your method, then click Next. The Custom Field Labels page appears (Figure 4-10).

Figure 4-10 Bath A: Custom Field Labels Wizard Page

18. Enter an appropriate name in the SampleName text box, then click Next. The Summary page appears, displaying summary information based on your selections and entries in the wizard (Figure 4-11).

Figure 4-11 Summary Wizard Page


19. If you are satisfied with your selections and entries in the wizard, click Finish. If you want to change a parameter value, click Back to return to a previous page. Make your changes, click Next until the Summary page appears, and click Finish.

Adding Components to Your Dissolution Sample Set Method

If you did not clear the Display the Component Editor when finished check box, the Component Editor will appear automatically (Figure 4-12). The Component Editor allows you to enter standard concentration amounts.

Figure 4-12 Sample Set Component Table

1. Select Edit > Copy Component from Process Method to display the Open an existing Process dialog box.

2. Select the name of the processing method you created in Section 3.3, Creating a Processing Method. Click Open.

STOPAttention: For the Empower Dissolution option to calculate amounts correctly, you must enter units/mL (for example, mg/mL) in the Units column of the Sample Set Component table. These units must match the units entered in the Bath A: Components page of the New Sample Set Method wizard (Figure 4-6).


3. To view the Units column, scroll to the far right of the Sample Set Component table.

4. Click the Component table to enter values. Enter an appropriate value for each component in the Component column, enter units/mL in the Units column, then click OK.

5. Select File > Save. The Save current sample set method dialog box appears (Figure 4-13).

Figure 4-13 Save Current Sample Set Method Dialog Box

6. Enter an appropriate name in the Name box, enter optional comments in the Comments box, then click Save. The Sample Set Method Editor appears with the new sample set method displayed in the title bar.

7. Select File > Exit to close the Sample Set Method Editor.

For more information on creating a dissolution sample set method, see the “Creating a Sample Set Method from the Project Window Using the Wizard” topic in the Empower Help.

4.3 Running a Dissolution Sample Set Method

To run a dissolution sample set method:

1. From the Project window, click (Run Samples), or select Tools > Run Samples. If you have more than one configured chromatographic system, the Select Desired Chromatography System dialog box appears (Figure 4-14).

Running a Dissolution Sample Set Method 47

Figure 4-14 Select Desired Chromatography System Dialog Box

2. Select the name of the system to make the run, then click OK. The Run Samples window appears with no sample set selected (Figure 4-15). Make sure you click the Samples tab (located at the bottom of the window).

Figure 4-15 Run Samples Window (Empty)

3. Select File > Load Samples. The Load Samples dialog box appears (Figure 4-16).


Figure 4-16 Load Samples Dialog Box

4. Click Load using a previously created sample set method and click OK. The Open an existing sample set method dialog box appears (Appendix 4-17).

5. Select the sample set method you created in Section 4.2, Creating a Dissolution Sample Set Method. The sample set method name and comments that you entered when you created the method appear.

Figure 4-17 Open an Existing Sample Set Method Dialog Box

6. Click Open. The Sample Set Method window appears (Figure 4-18), displaying the selected sample set. Check that Run and Report mode is selected. If you do not want to generate a report, select Run Only (refer to Section 5.2, Generating a Report, for more information).


Figure 4-18 Sample Set Method Window - Run Samples

7. From the Instrument Method drop-down list (Figure 4-18), select the instrument method you created in Section 3.1, Creating an Instrument Method, then click Setup.

If you did not include equilibration parameters in the instrument method you created in Section 3.1, Creating an Instrument Method, allow adequate time for the system to equilibrate before you start the sample set method.

8. To edit the dissolution sample set method, select Edit > Dissolution. The Dissolution tabs are displayed (Figure 4-19).

You can edit certain parameter values in each tab based on the Dissolution Type you selected in the Select Sample Set Method Type wizard page (Figure 4-2) and the parameter values you selected in subsequent Sample Set Method wizard pages. Click Help in the selected tab for information on editing dissolution parameter values.


Figure 4-19 Dissolution Property Tabs

9. In the Sample Set Method - Run Samples toolbar, click (Run), or from select Inject > Run Sample Set. The Run Sample Set dialog box appears (Figure 4-20).

Figure 4-20 Run Sample Set Dialog Box

10. Enter a name for the sample set. If you want to generate a report, click Select Printer, then from the list of available printers select the printer to print the dissolution report and click OK. Click Run.


11. When the 2690D/2695D generates an audible beep and the 2690D/2695D front panel displays the Drop Dosage Forms prompt (Figure 4-21), drop 6 or 8 pills simultaneously into the dissolution vessels, then press the OK screen key (on the 2690D/2695D front panel) to start the test.

Figure 4-21 Drop Dosage Forms Prompt for Single Bath

In the Empower Run Samples window the status bar indicates the status of the dissolution system and the sample set, for example, Idle, Setting Up, Injecting, Wait Transfer, Sample set – Waiting, and so on, as well as the elapsed time of the run.

As the sample transfers are made and injected, you can observe the peaks of the eluting components in the Plot window at the right of the Run Samples window.

After the sample set method runs, the software calculates the test results and, if you selected Run and Report in step 6, generates a report.

For information on the dissolution sample set calculations, see the “Dissolution Overview” and “Dissolution Functions (Samples Table)” topics in the Empower Help.

For information on reviewing results before a report is generated, see Section 5.1, Reviewing Results.

For information on previewing and editing the dissolution report before it is generated, see Section 5.2, Generating a Report.

For more information on running a single- or dual-bath dissolution test using the Alliance Dissolution System under Empower control, see the Waters Alliance Dissolution System Operator’s Guide, Chapter 6, Making a Run.


Chapter 5Reviewing Results and Generating Reports

After you complete the dissolution run, you can use the Empower software to:

• Review results from the sample set method you generated in Chapter 4, Developing and Running a Sample Set Method for Dissolution Testing

• Preview, edit, and generate a report from those results

5.1 Reviewing Results

After running the dissolution sample set method (see Section 4.3, Running a Dissolution Sample Set Method), you can view the dissolution results in Review and Preview using the Dissolution Plot reporting group. The results from the processed dissolution data show the amount dissolved as a function of transfer time for each component in the sample set method.

5.1.1 Displaying the Dissolution Results

To display the dissolution results from a sample set:

1. In the Project window, click the Sample Sets tab. Select the sample set method you created in Section 4.2, Creating a Dissolution Sample Set Method.

2. Select View > Results Sets.

3. Select the results set generated by the sample set method, then right-click Review, or select Tools > Review. The Review Main window appears (Figure 5-1).

Reviewing Results 53

Figure 5-1 Review Main Window

4. To view the chromatogram for each injection, expand the injection names in the Review data tree (Figure 5-1). The integrated peaks appear in the Review Main window, and information about each peak is displayed in the Review table (Figure 5-1).

5. If you make changes in the Review window, select File > Save, then select File > Exit. If you do not make changes to the results, click Exit to close Review and return to the Project window.

Note: If you make changes to the processed dissolution data while in Review, you need to reprocess the data to recalculate the dissolution results.

For more information on reprocessing data, see the “Background Processing Data” topic in the Empower Help.

For more information on the Review Main window, see the “Review Main Window” topic in the Empower Help.

For more information on the dissolution calculations, see the “Compute Dissolution Algorithm” topic in the Empower Help.

Review Data Tree

Review Table

Reviewing Results 54

5.2 Generating a Report

To generate a report from a dissolution sample set method:

1. In the Project window, click the Results Sets tab, then select the results set generated from the sample set method you created in Section 4.2, Creating a Dissolution Sample Set Method.

2. Right-click Preview/Publisher, or select Tools > Preview/Publisher. The Open Report Method dialog box appears (Figure 5-2).

Figure 5-2 Open Report Method Dialog Box

3. Click Use the following Report Method, select Dissolution from the drop-down list, then click OK. The Dissolution Report Preview appears (Figure 5-3).

4. In Preview, click Close in the toolbar to view Report Publisher.

Generating a Report 55

Figure 5-3 Dissolution Report Preview

5. In the Report Publisher report page (on the right), select a report group, then right-click Properties to review or change the properties associated with the dissolution plot.

For example, if you do not have a color printer, right-click Properties, then click the Colors tab. Change the Line Style attributes of each data line to distinguish one line from another, for example, dotted, dashed, and so on.

6. Select Print Preview to preview any changes.

7. Click Apply to apply the changes, then click OK to close the Report Group Properties dialog box.

8. To save the report method, select File > Save or Save As.

9. To print the report, click (Print), or select File > Print, then click OK. For an example of a dissolution report, see Figure 5-4.


Figure 5-4 Example of a Dissolution Report

10. To save a copy of the report (outside of Empower software), click (Save Report), or select File > Save Report. The Save As dialog box appears (Figure 5-5).

Figure 5-5 Save As Dialog Box


11. Select a folder, enter a file name, then specify one of the following file types in the Save as type text box:

• PDF Files (*.pdf), for PostScript Data Files

• EMF Files (*.emf), for Enhanced Metafiles

• TXT Files (*.txt), for ASCII Text File

12. Click Open to open the selected folder.

13. Click Save to save the report as a file (of the selected file type) in the selected folder.

14. To send a copy of a report attached to an e-mail message, click (Send Mail) in the Print Preview window. Empower software converts the report to a single file in the selected format (as in step 11), automatically launches your e-mail system, then attaches the report to an e-mail message.

Note: The Empower software report e-mail function uses the MAPI interface to communicate with the e-mail system. To use this feature, a MAPI-compliant e-mail system must be installed on the computer.

The dissolution report groups and report methods in this guide are provided with the default dissolution project. You can also create your own report groups and methods. For information on creating a report group, see the “Creating a Report Group” topic in the Empower Help.

For information on modifying the dissolution report group properties, see the “Modifying Dissolution Report Group Properties” topic in the Empower Help.

For more information on Report Publisher, see the “Report Publisher” topic in the Empower Help.


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