Waters Preparative Chromatography Mix Standard - Manual (Page 2)

[ CARE AND USE MANUAL ]
Preparative Chromatography Mix 2
between laboratories 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.
Determining your QCRM Criteria:
QCRM criteria should be determined based on specific requirements.
As mentioned above, specifications should not be set until the
variability of the system population is understood. The criteria and
specifications should allow it to be determined if the QCRM results
indicate that the system is functioning as expected or outside of
expectation. Typical criteria might include any of the following:
retention time reproducibility, peak area reproducibility, peak tailing
plate count, peak resolution, mass accuracy range, sensitivity
or response.
b. What affects your QCRM result:
The goal of the QCRM specifications and criteria will be to
indicate that the system is functioning as expected or outside
of expectation.
The system is comprised of many interdependent components
working together to produce results to an expected specification.
An issue with any one component can produce erroneous final
results. All components performing correctly will produce results
within an expected variability. Any changes or technical issues
within any one of the system components (hardware, software, or
chemical) may add variability to the QCRM result. Potential causes
of variability in QCRM results may include the following: mobile
phase preparation, column performance, tubing size, system
component performance (pump, injector, detector), temperature
control, data collection rate, integration.
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 compounds are stable through the expiration date listed
as provided in 1 mL amber ampule before opening. This product
is for one time usage. The integrity of the standard can not be
guaranteed if stored after first use.
III. USING THE PREPARATIVE CHROMATOGRAPHY MIX
For preparative chromatographic analysis on a 19 x 50 mm column the
Preparative Chromatography Standard mix was injected at 10 µL. The
injected quantity should be scaled for other column diameters.
Sample chromatography for the Preparative Chromatography
Standard is shown in Figure 1. Note that the use of different column
stationary phases and/or column dimensions will have a effect on
the separation. On different column chemistries or dimensions, the
method may need to be modified or re-developed to obtain sufficient
resolution. To properly transfer the separation across column
dimensions, use the Prep Calculator. www.waters.com/prepcalculator.
The table below indicated the approximate retention times obtained
for the compounds when using the specified chromatographic method
in Figure 1, as well as the m/z criteria for each compound.
Compound Type
MS
(M+ H)
Approximate RT (min)
(XSelect ™ CSH ™ C
18
, 5 µm,
19 x 50 mm)
220 nm
Diclofenac
sodium salt
Acid 296.02 4.6
Diphenhydramine
hydrochloride
Base 256.17 2.8
Flavone Neutral 223.07 4.3
Table 1: Preparative Mix UV and MS