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[ CARE AND USE MANUAL ]

Preparative Chromatography Mix

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

1 2 3 4 5 6 7

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[ CARE AND USE MANUAL ]Preparative Chromatography Mix1I. INTRODUCTIONThe Quality Control Reference Material (QCRM) portfolio is a unique collection o

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[ CARE AND USE MANUAL ]Preparative Chromatography Mix 2between laboratories should not be done without sufficient data trending. Once variability is u

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[ CARE AND USE MANUAL ]Preparative Chromatography Mix 3IV. QCRM TESTINGThe use of reference standards for QCRM testing should allow the analyst to tra

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[ CARE AND USE MANUAL ]Preparative Chromatography Mix 4Figure 2: Retention Time Control Chart The establishment of control limits provides data as t

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[ CARE AND USE MANUAL ]Preparative Chromatography Mix 5Related ProductsXSelect Preparative Columns XBridge Preparative ColumnsDescription Part NumberX

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[ CARE AND USE MANUAL ]Preparative Chromatography Mix 6SunFire Preparative Columns SunFire Preparative Scouting ColumnsSymmetryPrep ColumnsSymmetry300

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Waters Preparative Chromatography Mix Standard Manuale Utente

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