Waters Dye QCRM Kit - Manual (Page 2)

Dye Quality Control Reference Material Kit 2
[ CARE AND USE MANUAL ]
b. The Purpose of a Quality Control Reference Material
Waters recommends to benchmark a purification chromatographic
system with a QCRM prior to system usage when there is confidence
that the system is in good working order. It is recommended to run
and save the initial results and to continue to compare new QCRM
results to the previous benchmark before any critical assay is run,
and after any hardware, column, or mobile phase changes.
The QCRM standard benchmark result will be specific to the
performance of the system it is run on. All chromatographic systems
have some minor level of variability from run-to-run. Trending of
results over time is useful for defining variability on a single system,
multiple systems or on systems in different locations.
Setting specification for QCRM results should not be done without
sufficient data trending. Once variability is understood, QCRM
results will help determine the capability of the system to provide
reliable results.
c. What Affects Your Quality Control Reference
Material Results
The goal of the QCRM specifications and criteria will be to indicate
that the system is functioning as expected. The system is comprised
of many interdependent components working together to produce
results within an expected specification. An issue in any one of
the components can affect your QCRM result. Variability can
be attributed to hardware, software or chemical changes. All
components performing correctly will produce results within an
expected variability.
Sources of the variability that may affect system results include:
• Mobile phase preparation • Temperature control
• Column performance • Data collection rate
• Tubing size • Integration
• System component performance
(pump, injector, detector)
Differences in any of the components mentioned can result in system
to system variability of results even when each system’s components
are functioning correctly.
II. STORAGE AND STABILITY
The AutoPurification ™ Dye QCRM contains 3 compounds including
Thionin, Thioflavin T, and Crystal Violet. The compounds are stable
in their original packaging, through the expiration date listed as
provided in 10 mL amber ampule before opening. This is intended
to be a one time use product. The integrity of the standard can
not be guaranteed if stored after first use.
III. RECOMMENDED USAGE OF THE DYE QCRM
a. Testing System Performance
After installing FractionLynx ™ , it is recommended to test the system
to confirm that the instruments are functioning correctly, and that the
system produces the expected chromatographic results.
Testing involves using the Dye Kit (part number 716000765) to inject
dyes and subsequently collect them. A passing result for this system-
level test means that the system instruments function properly. If the
test results differ from those in the examples provided, ensure that
collection parameters are set appropriately.
The conditions defined in each of the following tests are designed
to help rapidly determine whether all the components function as a
system. Actual system performance (column load per run) depends
greatly on conditions such as the HPLC solvents or modifiers, and the
dimension of the columns.
For the MS-directed system test and the UV-directed system test,
many FractionLynx method parameters are identical, including the
gradient and UV detector parameters. The chromatogram examples
represent results that can be expected, although they can differ
somewhat from system to system.
b. Performing the Delay Timing Test Manually
Determine the delay time manually by injecting the dye standard
from the dye kit. The following test is conducted using a Waters
19 mm x 50 mm XTerra
® column.