WAT520-04r3 2487 OQ-2

Waters HPLC
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Systems
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Qualification
Workbook
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Recommended
Procedures for
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Operational Qualification
2487 Dual λ Absorbance
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Detector
Part IV: OQ
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34 Maple Street
Milford, MA 01757
WAT520-04, Revision 3
May 2006
NOTICE
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Waters instruments, software, and technical documentation are under revision control. The information
contained in this document is appropriate for the revision level of the specified instruments, software,
and technical documentation. This document is believed to be complete and accurate at the time of
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publication. Waters Corporation assumes no responsibility for any errors that may appear in this
document. In no event shall Waters Corporation be liable for incidental or consequential damages in
connection with or arising from the use of this documentation.
 1997—2006 WATERS CORPORATION. PRINTED IN THE UNITED STATES OF AMERICA

AND IRELAND. ALL RIGHTS RESERVED. THE PROTOCOLS AND FORMS IN THIS
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DOCUMENT HAVE REQUIRED EXTENSIVE DEVELOPMENT, TESTING, AND REFINEMENT
IN ORDER TO PROVIDE A QUALITY PRODUCT TO OUR CUSTOMERS. AS SUCH, THIS
DOCUMENT IS REGARDED AS INTELLECTUAL PROPERTY OF WATERS. EXCEPT WHERE
INDICATED, THIS DOCUMENT OR PARTS THEREOF MAY NOT BE REPRODUCED IN ANY
FORM WITHOUT THE WRITTEN PERMISSION OF THE PUBLISHER.
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Waters Service Technicians are not authorized to make entries into unauthorized photocopied
documents. To obtain additional documents, contact your Waters representative.
Waters is a registered trademark of Waters Corporation.

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Microsoft and Windows are registered trademarks of Microsoft Corporation

All other trademarks or registered trademarks are the sole property of their respective owners.
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Table of Contents
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1.1 Introduction .......................................................................................................................... 5
1.2 Scope of Operational Qualification...................................................................................... 6
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1.3 Preliminary Operational Qualification Procedures .............................................................. 6
1.3.1 Identifying Performers and Reviewers................................................................. 6
1.3.2 Identifying the Detector ....................................................................................... 7
1.4 Operational Qualification Procedures .................................................................................. 8
1.4.1 Confirming the Startup Diagnostics and Calibration ......................................... 10
1.4.2 Wavelength Accuracy Test ................................................................................. 10
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1.4.3 Performing the Linearity Test............................................................................. 13
1.4.4 Using the Windows Calculator (Optional) ......................................................... 15
1.5 Operational Qualification Log ........................................................................................... 19
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WAT520-04, Revision 3 3 of 22
Forms
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Form 1-1 Identification of Performers and Reviewers ........................................................................7
Form 1-2 Identification of System Components .................................................................................8
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Form 1-3 2487 Detector Startup Diagnostics and Wavelength Accuracy Results ...........................17
Form 1-4 2487 Detector Linearity Test Results ...............................................................................18
Form 1-5 Operational Qualification Log for the 2487 Detector........................................................19
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4 of 22 WAT520-04, Revision 3
Part IV: OQ for 2487 Dual λ Absorbance Detector
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Operational Qualification
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The Waters HPLC Systems Qualification Workbook, Recommended Procedures for Operational
Qualification, 2487 Dual λ Absorbance Detector, Part IV: OQ presents the operational qualification
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process for the Waters 2487 Dual λ Absorbance Detector. Use this workbook to qualify the Waters
2487 Dual λ Absorbance Detector in a GLP-, CGMP-, and/or GALP-regulated environment and/or an
ISO 9000-series registered facility.
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1.1 Introduction
This workbook guides a trained and qualified person through the operational qualification of a Waters
2487 Dual λ Absorbance Detector.
Recommended Documents EN
Use this workbook with the Waters 2487 Dual λ Absorbance Detector Operator’s Guide* (part
number WAT048740), and with other referenced documentation to perform operational qualification
on the Waters 2487 Dual λ Absorbance Detector.
*This document is also available as a PDF file from the Waters Web site at http://www.waters.com.
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Before You Begin
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Before beginning the procedures in this workbook (Part IV: OQ), be sure to read and understand the
procedures in the Waters Chromatography Systems Qualification Workbook, System Qualification
Overview, Part I: OV. In particular, note these areas:
• Instructions about completing forms
• Guidelines for requalifying the Waters 2487 Dual λ Absorbance Detector
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• Management approval of system qualification protocols

• Information about using this workbook
Also perform the procedures in the Part II: IQ or Part III: MP, as appropriate.
After Operational Qualification

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After completing the operational qualification of the Waters 2487 Dual λ Absorbance Detector,
qualified performers and reviewers must complete the system qualification by performing tasks
described in the Part V: PQ workbook. Also, owner’s management must approve the system’s
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successful qualification by completing the approval form at the end of the Part V: PQ workbook.
Waters HPLC Systems Qualification Workbook
1.2 Scope of Operational Qualification
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1 Operational qualification involves confirming that the 2487 Detector meets operational standards for:
• Startup diagnostics
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• Wavelength accuracy
• Linear response to analyte concentration
1.3 Preliminary Operational Qualification Procedures
1.3.1 Identifying Performers and Reviewers
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To identify the performers qualified to perform the operational qualification of the 2487 Detector, and
to identify the reviewers qualified to acknowledge the successful completion of the performers’ tasks,
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complete Form 1-1.
Note: If no second performer or reviewer participates, enter N/A in the unused Name line of Form 1-1.
If you have not already done so, file a copy of the performer’s Compliance Training Certificate(s) at
the end of the Overview (Part I: OV) section of this workbook.
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Form 1-1 Identification of Performers and Reviewers
The undersigned performers attest that they are trained and qualified to perform operational qualification of a Waters 2487 Dual λ
Absorbance Detector.
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Performer
Name (print) Signature Initials
Title Date
(Trained and qualified to perform qualification procedures)
Performer
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Title Date
(Trained and qualified to perform qualification procedures)
The undersigned reviewers accept that the performers named above are trained and qualified to perform operational qualification of a
Waters 2487 Dual λ Absorbance Detector.
Reviewer
Name (print)
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Title Date
(Owner-designated responsible person)
Reviewer
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Title Date
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(Owner-designated responsible person)
 2006 Waters Corporation
1.3.2 Identifying the Detector

Complete Form 1-2 to identify the detector to be qualified.
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Obtaining the Serial Number

Identify the Waters 2487 Dual λ Absorbance Detector by locating its serial number on the back or
inside the left front panel of the detector. Enter the number in Form 1-2.
Obtaining the Firmware Revision Number

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1. Power-on the Waters 2487 Dual λ Absorbance Detector.

2. After the detector performs its internal startup diagnostics (about 5 minutes) and displays the
Absorbance screen, press the System Info (Shift 4) key to display the detector name, firmware
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revision number, and serial number.

Note: The firmware revision number may be displayed as “Software Rev x.xx” on the System
Info screen.
3. Enter the firmware revision number in Form 1-2.
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Form 1-2 Identification of System Components
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Equipment Name Waters 2487 Dual λ Absorbance Detector
Manufacturer Waters Corporation, 34 Maple Street, Milford, MA 01757 U.S.A.
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2487 Detector
Serial Number
Firmware Revision
Number
Owner’s Equipment
Number
Certification
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The undersigned performer attests that the instrument information shown above is accurate and complete.
Performer Date
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Signature
The undersigned reviewer accepts that the instrument information shown above is accurate and complete.
Reviewer Date
Signature

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1.4 Operational Qualification Procedures
This section provides the procedures you need to confirm the operation of the Waters 2487 Dual λ
Absorbance Detector.
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Note: Before performing the function tests in this section, all performers and reviewers must familiarize
themselves with the Waters 2487 Dual λ Absorbance Detector Operator’s Guide.
You can perform the operational qualification tests using one of the following methods:
• Prepared cuvettes and/or cuvettes that you fill with test solution
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• The flow cell (the detector may be tested using the standard 10-mm flow cell or any of the
optional flow cell types available for the 2487 Detector, see Table 1-1)
Table 1-1 Optional Flow Cells for the 2487 Detector
Flow Cell Type Volume (µL) Path Length (mm)

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Analytical Cell 10 10
Semi-Prep Cell 2.6 3
Microbore Cell 2.6 3
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Inert (Titanium) Cell 10 10

High-Pressure Cell for LC/MS 10 10
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Recommended Materials for All Methods
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• Document(s) that pertain to your 2487 Detector (see “Recommended Documents” on page 5)
• HPLC-grade water, 20 mL
• HPLC-grade methanol, 50 mL
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• Scientific calculator accessible from the Microsoft operating system, or any scientific
calculator
Recommended Materials When Using Cuvettes

Note: When you perform the operational qualification tests using cuvettes, the type and path length of
the flow cell are not a consideration.
• Waters Absorbance Detector Wavelength Accuracy Cuvette Kit, part number WAT047690
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• Waters Absorbance Detector Linearity Cuvette Kit, part number WAT047691
If you are filling empty cuvettes:
• Waters Erbium Perchlorate Wavelength Accuracy Solution, part number WAT042885
• Waters Absorbance Detector Linearity Test Solution, part number WAT042881
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Two empty matched cuvettes, for the wavelength accuracy test
Six empty matched cuvettes, for the linearity test
• A clean non-particulating cloth or lens tissue
Recommended Materials When Using a Flow Cell

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• 10-cc syringe, part number WAT027629
• Priming syringe needle, part number WAT025559
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• Waters Erbium Perchlorate Wavelength Accuracy Solution, part number WAT042885

• Waters Absorbance Detector Linearity Test Solution, part number WAT042881 (for all 10-mm
flow cells)
• Waters Absorbance Detector Linearity Test Solution, part number WAT047634 (for all 3-mm
flow cells)
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Recording Lot Numbers

Record in Form 1-3 and Form 1-4 the lot numbers and expiration dates of the following items, as
appropriate:
• Waters Absorbance Detector Wavelength Accuracy Cuvette Kit
• Waters Erbium Perchlorate Wavelength Accuracy Solution
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• Waters Absorbance Detector Linearity Cuvette Kit

• Waters Absorbance Detector Linearity Test Solution (either for 10-mm or 3-mm path length
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flow cells)
1.4.1 Confirming the Startup Diagnostics and Calibration
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1 To confirm the 2487 Detector startup diagnostics and calibration:
1. Power-on the 2487 Detector and wait for the startup diagnostics to run. The front panel displays
a series of startup verification messages for about five minutes.
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If the startup diagnostics fail, note the resultant error message to determine the appropriate
corrective action. Refer to the Waters 2487 Dual λ Absorbance Detector Operator’s Guide, part
number WAT048740.
2. After successfully initializing, the 2487 Detector displays the Absorbance screen (Figure 1-1).
3. Complete the Startup Diagnostics entries in Form 1-3.
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Figure 1-1 2487 Detector Absorbance Screen (Example)
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1.4.2 Wavelength Accuracy Test
The wavelength accuracy test confirms that programmed wavelengths are within accuracy
specifications.
Note: To ensure maximum testing accuracy, power-on the 2487 Detector at least 60 minutes before
you perform this test. Also, note that no column is required for this test.
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Note: To ensure against fingerprints or other marks on the cuvettes, wipe them as required using lens
tissue or a clean, non-particulating cloth.
Before you perform the wavelength accuracy test for the 2487 Detector, be sure you have cuvettes
containing these solutions:
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• One cuvette (labeled) containing 3 mL of HPLC-grade water

• One cuvette (labeled) containing 3 mL of 10 g/L erbium perchlorate in HPLC-grade water
If you are filling empty cuvettes:
1. Rinse two cuvettes at least three times using HPLC-grade water.
2. Fill (and label) the clean, empty cuvettes.
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Note: When you fill empty cuvettes, the erbium perchlorate-filled cuvette can be used within 1
year (not to exceed the expiration date of the erbium perchlorate solution) if capped and kept
away from heat and light. Results obtained after 1 year may not be reliable. The water-filled
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cuvette can be used within 72 hours if capped and kept away from heat and light. Results
obtained after 72 hours may not be reliable.
3. Flush the 2487 Detector with HPLC-grade water for at least 10 minutes at 1 mL/min. Use an
intermediate solvent, if required.
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Proceed to the “Testing Wavelength Accuracy” procedure below.
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Preparing the Flow Cell
Before you use a flow cell to perform the wavelength accuracy test:
1. Flush the 2487 Detector with HPLC-grade water for at least 10 minutes at 1 mL/min. Use an
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intermediate solvent if required.
2. Run a zero scan on the water in the flow cell as described in step 1 of the “Testing Wavelength
Accuracy” procedure, below.
3. Disconnect the 2487 Detector inlet and outlet lines from the system.
4. Rinse the 10-cc syringe twice with 1 mL of the Waters Erbium Perchlorate Wavelength
Accuracy Solution.
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5. Inject 5 mL of the wavelength accuracy solution (10 g/L erbium perchlorate in HPLC-grade
water) into the detector’s flow cell inlet line using the 10-cc syringe and the priming syringe
needle.
6. Allow the erbium perchlorate solution to remain in the flow cell for 15 to 30 seconds.
Proceed to step 3 of the “Testing Wavelength Accuracy” procedure, below.
Testing Wavelength Accuracy

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To perform the wavelength accuracy test on the 2487 Detector:
1. Using the water cuvette (or the flow cell, if you are not using cuvettes), run a zero scan at the
2487 Detector as follows:
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a. Press SCAN (Shift Chart Mark), 1, New Scan, and then press 2, Zero Scan.
b. Press Next to advance to the second Zero Scan parameter screen.
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c. Enter 245 (starting wavelength) for the zero scan, and then press Enter.
d. Enter 545 (ending wavelength) for the zero scan, and then press Enter.
e. Enter 100 nm/min (default) in the Pace field specifying the rate at which the 2487 Detector
scans the specified wavelength range.
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f. Press Next to advance to the third Zero Scan parameter screen.

g. Enter 2, for the AUFS value (default), and then press Enter.
h. Press Run to start the zero scan now, or press Next to return to the first Zero Scan parameter
screen to confirm entry of the correct parameters. Then press Run.
When the 2487 Detector completes running the zero scan, the Scan choice list is displayed.
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2. Remove the cuvette holder. Then remove the water cuvette, replacing it with the cuvette
containing erbium perchlorate. Finally, reinstall the cuvette holder.
3. Run a sample scan at the 2487 Detector as follows:
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a. Press SCAN (Shift Chart Mark), 1, New Scan. Then press 1, Sample Scan.
b. Ensure that the wavelength range (starting and ending wavelengths), Pace, and AUFS
parameters correspond to the parameters you entered when performing step 1.
c. Press Run to run the sample scan.
d. When the scan ends, the 2487 Detector displays the sample scan, as shown in the example in
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Figure 1-2.
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Figure 1-2 Erbium Perchlorate Wavelength Accuracy Scan (Example)
e. Press Next to display as many as four of the highest peaks scanned (λ max). Figure 1-3 shows
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the display as it looks when reporting the four highest peaks for the sample erbium
perchlorate scan shown in Figure 1-2.
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Figure 1-3 Four Highest Peaks of Erbium Perchlorate Wavelength Accuracy Scan (Example)
4. On Form 1-3, record the wavelength values displayed for the indicated peaks. Each peak value
has a tolerance of ±2.0 nm. Complete the remainder of Form 1-3.
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Note: The tolerance of ±2.0 nm is an additive value that is determined as follows:

• The 2487 Detector’s wavelength accuracy specification of ±1.0 nm
• The National Institute of Standards and Technology (N.I.S.T.) certifiable spectral data on
erbium perchlorate with instrumentation accuracy of ±0.5 nm
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• The 2487 Detector’s 1 nm “binning” of data (the 2487 display reports wavelength to the
nearest whole nanometer)
Storing the Scan (Optional)

See the Waters 2487 Dual λ Absorbance Detector Operator’s Guide, part number WAT048740, for
information on storing spectra results.
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If you want to store the wavelength accuracy scan for later review:
1. Press HOME to return to the Absorbance screen.
2. Press SCAN (Shift Chart Mark), 2, Store a Scan. The default slot number appears.
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3. If desired, change the slot number to any number from 1 through 5.

4. Press Enter to enter the wavelength accuracy scan results into the 2487 Detector memory.
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See the Waters 2487 Dual λ Absorbance Detector Operator’s Guide for information on reviewing a
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stored scan. You can use the detector’s Scale function to display specific areas of a peak of interest.
1.4.3 Performing the Linearity Test

The 2487 Detector Linearity Test verifies the detector’s linear response under specific test conditions.
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Determine linearity for compounds in your applications during method validation. The linearity
specification for the 2487 Detector is 5%, at 2.5 AU, using propylparaben at 257 nm.
Note: To ensure maximum testing accuracy, power-on the 2487 Detector at least 60 minutes before
you perform this test. Also, note that no column is required for this test.
The Linearity Test can be performed using a flow cell or cuvettes. If you use a flow cell, follow the
procedure in Section 1.4.3.1, Performing the Linearity Test Using a Flow Cell. If you use cuvettes,
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follow the procedure in Section 1.4.3.2, Performing the Linearity Test Using Cuvettes.
1.4.3.1 Performing the Linearity Test Using a Flow Cell

For 10-mm flow cells (see Table 1-1), use the Waters Absorbance Detector Linearity Test Solution,
part number WAT042881, in concentrations of 0 (for methanol), 5 10, 20, 25, and 30 mg/L. The
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concentration of 15 mg/L is not used for the 10-mm flow cell.
For 3-mm flow cells (see Table 1-1), use the Waters Absorbance Detector 3-mm Linearity Test
Solution, part number WAT047634, in concentrations of 0 (for methanol), 15, 30, 60, 75, and 90 mg/L
(for comparable detector output signals, a 3-mm flow cell needs about three times the concentration of
test solution as a 10-mm flow cell). The concentration of 45 mg/L is not used for the 3-mm flow cell.
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To prepare for the Linearity Test using the flow cell:
1. Flush the flow cell with HPLC-grade methanol for at least 10 minutes at 1 mL/min.
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2. Disconnect the 2487 Detector’s inlet and outlet lines from the system.
3. In Form 1-4, Column B, record the concentration (mg/L) of each test solution (as indicated on its
corresponding Certificate of Analysis).
4. Set the 2487 Detector’s wavelength to 257 nm (λ = 257).
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5. Starting with 100% methanol (ampule 1), fill the flow cell using the 10-cc syringe. Leave the
syringe connected to the flow cell inlet while you observe readings. Allow 15 to 30 seconds for
the 2487 Detector’s display to stabilize.
Note: Avoid injecting bubbles.
6. Auto zero the detector by pressing the Auto Zero key on the front panel.
7. Record the absorbance value for test solution 1 in Form 1-4, Column C.
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8. Draw 1 mL of test solution 2 from the Absorbance Detector Linearity Kit (ampule 2) into the
syringe as a wash, and then discard it. Do this two more times.
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9. Refill the syringe with 3 to 5 mL of test solution 2, and then flush the flow cell with the contents
of the syringe. Allow 15 to 30 seconds for the 2487 Detector’s display to stabilize.
11. Continue to use test solutions in ampules 3, 5, 6, and 7 according to step 8 through step 10. Do
not use the solution in ampule 4.
12. Calculate the sensitivity value of each solution, the mean sensitivity value, the standard
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deviation, and the %RSD, and record these values in the appropriate columns of Form 1-4.
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If you use the Windows scientific calculator, see Section 1.4.4, Using the Windows Calculator
(Optional).
Note: To avoid round-off or truncation errors, calculate the sensitivity values (Column D) and the
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mean and standard deviation of the sensitivity values to five decimal places to the right of the
decimal point. Calculate the %RSD to two decimal places to the right of the decimal point.
13. Enter your pass/fail test results in Form 1-4.

14. Complete the remainder of Form 1-4.
1.4.3.2 Performing the Linearity Test Using Cuvettes
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1. If you are filling empty cuvettes, obtain these items:
• An ampule kit (Waters Absorbance Detector Linearity Test Solution, part number
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WAT042881) containing 10 mL of solution at each concentration specified in step 4, below.
• Six empty cuvettes with caps labeled to correspond to the concentrations of linearity testing
solutions obtained from the ampule kit.
2. Rinse each cuvette at least three times with HPLC-grade methanol.
3. Rinse each cuvette three times with approximately 1 mL of the appropriate test solution,
obtained from the ampule kit.
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4. Fill each cuvette with 3 to 4 mL of the test solution of the appropriate concentration as listed,
then screw on the appropriate labeled cap finger-tight:
a. Cuvette 1: HPLC-grade methanol, 100%
b. Cuvette 2: propylparaben, 5 mg/L in HPLC-grade methanol
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c. Cuvette 3: propylparaben, 10 mg/L in HPLC-grade methanol

d. Cuvette 4: propylparaben, 20 mg/L in HPLC-grade methanol
e. Cuvette 5: propylparaben, 25 mg/L in HPLC-grade methanol
f. Cuvette 6: propylparaben, 30 mg/L in HPLC-grade methanol
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Note: The Waters Linearity Test Solution Kit (part number WAT042881) contains seven
ampules. When using cuvettes, do not use the ampule containing the 15-mg/L concentration
(ampule #4). Use the six remaining ampules to fill the cuvettes as indicated above.
Note: Linearity Test cuvettes are usable within 72 hours of filling when capped and kept away
from heat and light. Results obtained after 72 hours may not be reliable due to evaporation
altering the concentration in the cuvette, which would then affect the absorbance value of the
solution.
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5. Ensure that the labeled caps identify each solution correctly.

6. In Form 1-4, Column B, record the concentration (mg/L) of each test solution (as indicated on its
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corresponding Certificate of Analysis).

7. After each use, rinse the cuvettes with HPLC-grade methanol.
8. Flush the 2487 Detector with HPLC-grade methanol for at least 10 minutes at 1 mL/min.
9. Set the 2487 Detector’s wavelength to 257 nm (λ = 257).
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10. Insert the cuvette containing methanol.
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11. Allow the detector to stabilize for about 10 seconds, then auto zero the it by pressing the Auto
Zero key on the front panel. Record the absorbance value for Solution #1 (methanol) in
Form 1-4, Column C.
12. Remove the cuvette holder, remove the methanol cuvette, insert the cuvette containing the
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correct concentration for Linearity Test solution 2, and then reinstall the cuvette holder. Allow
the detector to stabilize for about 10 seconds.
14. Repeat step 11 through step 13 for each successive Linearity Test solution.
15. Calculate the sensitivity value of each solution, the mean sensitivity value, the standard
deviation, and the %RSD. Record these values in the appropriate columns in Form 1-4.
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If you use the Windows scientific calculator, see Section 1.4.4, Using the Windows Calculator
(Optional).
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1.4.4 Using the Windows Calculator (Optional)

To calculate the sensitivity value of each solution, the mean sensitivity value, the standard deviation,
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and the %RSD, you may want to use the Windows scientific calculator. To access the scientific
calculator on your PC:
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1. Select Start > Programs > Accessories > Calculator. The calculator appears.
2. Select View > Scientific. The calculator switches to scientific view.
3. Divide the absorbance value in Column C by the corresponding concentration value in Column
B (Column C/Column B) to obtain the sensitivity values for each test solution. Record the
sensitivity values in Column D in Form 1-4.
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4. Calculate the mean of the five sensitivity values entered in Column D. Record the mean
sensitivity value in Form 1-4.
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5. Calculate the standard deviation of the five sensitivity values recorded in Column D:
a. In the calculator window, enter the sensitivity value for Linearity Test solution 2.
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b. Click the Sta button in the left column of the calculator. The Statistics Box appears.
c. Click the Dat button in the left column of the calculator. When you click the Sta button again,
the Statistics Box displays the first sensitivity value entered.
d. Enter the sensitivity values for the remaining test solutions using the Dat button to enter each
value into the Statistics Box.
e. After you enter all sensitivity values in the Statistics Box, click the s button in the left
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column of the calculator to calculate the standard deviation.
1 6. Record the standard deviation in Form 1-4.
7. Calculate the %RSD using the formula provided in Form 1-4, then record the value in Form 1-4.
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Form 1-3 2487 Detector Startup Diagnostics and Wavelength Accuracy Results
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Waters 2487 Dual λ Absorbance Detector Serial Number
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Waters Absorbance Detector Wavelength Accuracy Solution
Lot Number Expiration Date
Pass Fail
Startup Diagnostics
Initials Initials
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Flow Cell Cuvettes
Test Performed Using

Initials Initials
Wavelength Accuracy EN
Measured Peak Value (nm) Expected Peak Value (nm) Pass Fail
255 (±2.0 nm)

Initials Initials
379 (±2.0 nm)
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522 (±2.0 nm)
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Comments
Certification
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The undersigned performer attests that the information recorded above is accurate and complete.
Performer Date
Signature
The undersigned reviewer accepts that the information recorded above is accurate and complete.
Reviewer Date
Signature
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Form 1-4 2487 Detector Linearity Test Results
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1 Waters 2487 Dual λ Absorbance Detector Serial Number
Flow Cell Cuvettes
Test Performed Using

Initials Initials
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Installed Flow Cell Type (See Table 1-1)
Waters Absorbance Detector Linearity Solution
Lot Number Expiration Date
Column A Column B Column C Column D
Concentrations Concentrations Linearity Concentration Abs Sensitivity =

for for Test (mg/L) from Abs/
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Cuvettes or 3-mm Flow Cell Solution Certificate of Concentration
10-mm Flow Cell Analysis {Column C/
Column B}
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x.xxxxx
0 0 Solution 1 0 ___________ N/A

(methanol)
5 15 Solution 2 ___________ ___________ ___________
10 30 Solution 3 ___________ ___________ ___________

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15 45 Solution 4 Not Used Not Used Not Used
20 60 Solution 5 ___________ ___________ ___________
25 75 Solution 6 ___________ ___________ ___________

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30 90 Solution 7 ____________ ____________ ____________
Mean of Sensitivity Values (Column D)

x.xxxxx
Standard Deviation of Sensitivity Values (Column D)
x.xxxxx
Standard Deviation × 100
Calculated %RSD =
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Mean
Calculated %RSD Acceptable Value Test Result
<4.5% Pass Fail

x.xx Initials Initials
Comments
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Certification
The undersigned performer attests that the values recorded and calculated above are accurate.
Performer Date
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Signature
The undersigned reviewer accepts that the values recorded and calculated above are accurate.
Reviewer Date
Signature
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1.5 Operational Qualification Log
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Use Form 1-5 to compile a record of operational qualification procedures performed on the Waters
2487 Dual λ Absorbance Detector, including those performed after scheduled maintenance procedures
and corrective servicing.
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Note: Before you enter information on the last page of Form 1-5, make additional copies of the form.
Insert the copies behind the original.
Form 1-5 Operational Qualification Log for the 2487 Detector
The undersigned attest and accept that the operational qualification procedures recorded below were performed on the Waters 2487
Dual λ Absorbance Detector, and all approval signatures were obtained, where necessary.
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Waters 2487 Dual λ Absorbance Detector Serial Number______________________________________
Service Report Number
Procedure
Performer
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Date
Reviewer Date
Signature
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Procedure
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Performer Date
Signature
Reviewer Date
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Signature
Procedure
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Performer Date
Signature
Reviewer Date
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Signature
Form 1-5 Operational Qualification Log for the 2487 Detector (Continued)
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1 The undersigned attest and accept that the operational qualification procedures recorded below were performed on the Waters 2487
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Procedure
Performer Date
Signature
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Reviewer Date
Signature
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Procedure
Performer Date
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Signature
Reviewer Date
Signature
Procedure
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Performer Date
Signature
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Reviewer Date
Signature
Procedure
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Performer Date
Signature
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Reviewer Date
Signature
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The undersigned attest and accept that the operational qualification procedures recorded below were performed on the Waters 2487
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Procedure
Performer Date
Signature
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Reviewer Date
Signature
Procedure
Performer
EN Date
Signature
Reviewer Date
Signature
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Procedure
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1 The undersigned attest and accept that the operational qualification procedures recorded below were performed on the Waters 2487
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Waters HPLC

 1997—2006 WATERS CORPORATION. PRINTED IN THE UNITED STATES OF AMERICA

Waters is a registered trademark of Waters Corporation.

Microsoft and Windows are registered trademarks of Microsoft Corporation

• Management approval of system qualification protocols

After Operational Qualification

1.2 Scope of Operational Qualification

1.3 Preliminary Operational Qualification Procedures

1.3.1 Identifying Performers and Reviewers

(Owner-designated responsible person)

 2006 Waters Corporation

1.3.2 Identifying the Detector

Obtaining the Serial Number

Obtaining the Firmware Revision Number

1. Power-on the Waters 2487 Dual λ Absorbance Detector.

revision number, and serial number.

3. Enter the firmware revision number in Form 1-2.

Manufacturer Waters Corporation, 34 Maple Street, Milford, MA 01757 U.S.A.

 2006 Waters Corporation

Table 1-1 Optional Flow Cells for the 2487 Detector

Flow Cell Type Volume (µL) Path Length (mm)

Inert (Titanium) Cell 10 10

Recommended Materials for All Methods

Recommended Materials When Using Cuvettes

Recommended Materials When Using a Flow Cell

• Waters Erbium Perchlorate Wavelength Accuracy Solution, part number WAT042885

Recording Lot Numbers

• Waters Absorbance Detector Linearity Cuvette Kit

1.4.1 Confirming the Startup Diagnostics and Calibration

• One cuvette (labeled) containing 3 mL of HPLC-grade water

Proceed to the “Testing Wavelength Accuracy” procedure below.

Testing Wavelength Accuracy

f. Press Next to advance to the third Zero Scan parameter screen.

Note: The tolerance of ±2.0 nm is an additive value that is determined as follows:

Storing the Scan (Optional)

3. If desired, change the slot number to any number from 1 through 5.

1.4.3 Performing the Linearity Test

1.4.3.1 Performing the Linearity Test Using a Flow Cell

13. Enter your pass/fail test results in Form 1-4.

1.4.3.2 Performing the Linearity Test Using Cuvettes

c. Cuvette 3: propylparaben, 10 mg/L in HPLC-grade methanol

5. Ensure that the labeled caps identify each solution correctly.

corresponding Certificate of Analysis).

10. Insert the cuvette containing methanol.

1.4.4 Using the Windows Calculator (Optional)

Test Performed Using

255 (±2.0 nm)

 2006 Waters Corporation

Form 1-4 2487 Detector Linearity Test Results

Flow Cell Cuvettes

Test Performed Using

Column A Column B Column C Column D

Concentrations Concentrations Linearity Concentration Abs Sensitivity =

0 0 Solution 1 0 ___________ N/A

5 15 Solution 2 ___________ ___________ ___________

10 30 Solution 3 ___________ ___________ ___________

20 60 Solution 5 ___________ ___________ ___________

25 75 Solution 6 ___________ ___________ ___________

30 90 Solution 7 ____________ ____________ ____________

Mean of Sensitivity Values (Column D)

<4.5% Pass Fail

1.5 Operational Qualification Log

Form 1-5 Operational Qualification Log for the 2487 Detector

Service Report Number

5 15 Solution 2 _____ _ _______

10 30 Solution 3 _____ _ _______

20 60 Solution 5 _____ _ _______

25 75 Solution 6 _____ _ _______

30 90 Solution 7