Waters Preparative Chromatography Mix Standard - Manual

[ CARE AND USE MANUAL ]
Preparative Chromatography Mix 1
I. INTRODUCTION
The Quality Control Reference Material (QCRM) portfolio is a unique
collection of standards and mixtures. These products allow users to
evaluate and benchmark the chromatography system before analysis
of critical material. The products in the portfolio are all precisely
formulated based on the expertise of Waters scientist.
The preparative chromatography mix is 5 mg/mL each of Diclofenac
sodium salt, Diphenhydramine hydrochloride, and Flavone in DMSO.
This standard mix should be used to confirm the benchmark
performance of your Preparative/purification system. This particular
QCRM is a precisely formulated mix that includes a void marker,
neutral, acidic and basic compounds. These compounds were
vigorously tested and evaluated and chosen because they provide
the following advantages:
– Well-separated
– Easily visually identified
– Acceptable for use on a variety of column
a. The Purpose of a QCRM:
Waters recommends to benchmark your chromatographic system with
a QCRM prior to system usage when there is confidenence your system
is in good working order. It is recommended to run and save the
initial results and continue to compare your QCRM results to the
previous benchmark any critical assay is run, and after any hardware,
column or mobile phase changes.
The QCRM 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 the benchmark
results over time will provide an understanding of system typical
variability. Trending of the same QCRM result on multiple systems
will provide the typical variability of those systems. Trending of the
same QCRM result on systems in laboratories in different locations
will provide the typical variability from across locations. Setting
specification for QCRM results of a system, multiple systems or
Preparative Chromatography Mix Standard
CONTENTS
I. INTRODUCTION
a. The Purpose of a QCRM
b. Determining your QCRM Criteria
c. What Affects your QCRM Result
II. STORAGE & STABILITY
III. USING THE PREPARATIVE CHROMATOGRAPHY MIX
IV. QCRM TESTING
V. TROUBLESHOOTING
VI. ORDERING INFORMATION