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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

Summary of content (7 pages)

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[ CARE AND USE MANUAL ] Preparative Chromatography Mix Standard CONTENTS I. INTRODUCTION I. INTRODUCTION The Quality Control Reference Material (QCRM) portfolio is a unique a. The Purpose of a QCRM collection of standards and mixtures. These products allow users to b. Determining your QCRM Criteria evaluate and benchmark the chromatography system before analysis c. What Affects your QCRM Result of critical material.
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[ CARE AND USE MANUAL ] II. STORAGE AND STABILITY: between laboratories should not be done without sufficient data trending. Once variability is understood, QCRM results will help T he compounds are stable through the expiration date listed determine the capability of the system to provide reliable results. as provided in 1 mL amber ampule before opening. This product is for one time usage. The integrity of the standard can not be Determining your QCRM Criteria: guaranteed if stored after first use.
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[ CARE AND USE MANUAL ] 2 3 1. Diphenhydramine 2. Flavone 3. Diclofenac 8.0e-1 6.0e-1 1 AU Figure 2 shows an example of the chromatography obtained for the preparative mix via UV and MS when the method in Figure 1 is using an XSelect™ CSH C18, 5 µm, 19 x 50 mm. 4.0e-1 220 nm 2.0e-1 0.0 1 2 3 4 5 6 7 8 9 10 min 9 10 min 99 % TIC; ES + -1 1 2 3 4 IV.
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[ CARE AND USE MANUAL ] V. TROUBLESHOOTING: Figure 2: Retention Time Control Chart 1 2 3 4 5 6 Time (min) Initial 0.10 6.10 7.10 7.20 10.10 Flow (mL/min) 25.00 25.00 25.00 25.00 25.00 25.00 %A %B Curve 95.0 95.0 5.0 5.0 95.0 95.0 5.0 5.0 95.0 95.0 5.0 5.0 Initial 6 6 6 6 6 The Preparative Chromatography Standard contains an acidic, basic and neutral compound. Due to the vastly different properties of stationary phases, not all compounds will behave similarly on each column.
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[ CARE AND USE MANUAL ] Related Products XSelect Preparative Columns XBridge Preparative Columns Description Part Number Description Part Number XSelect CSH C18 OBD, 5 µm, 19 x 50 mm XSelect CSH C18 OBD, 5 µm, OBD 19 x 100 mm XSelect CSH C18 OBD, 5 µm, OBD 19 x 150 mm XSelect CSH C18 OBD, 5 µm, OBD 19 x 250 mm XSelect CSH C18 OBD, 5 µm, OBD 30 x 50 mm XSelect CSH C18 OBD, 5 µm, OBD 30 x 75 mm XSelect CSH C18 OBD, 5 µm, OBD 30 x 100 mm XSelect CSH C18 OBD, 5 µm, OBD 30 x 150 mm XSelect CSH C18 OBD, 5
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[ CARE AND USE MANUAL ] SunFire Preparative Columns SunFire Preparative Scouting Columns Description Part Number Description Part Number SunFire C18 OBD Prep Column, 100Å, 5 µm, 19 x 50 mm SunFire C18 OBD Prep Column, 100Å, 5 µm, 19 x 100 mm SunFire C18 OBD Prep Column, 100Å, 5 µm, 19 x 150 mm SunFire C18 OBD Prep Column, 100Å, 5 µm, 19 x 250 mm SunFire C18 OBD Prep Column, 100Å, 5 µm, 30 x 50 mm SunFire C18 OBD Prep Column, 100Å, 5 µm, 30 x 75 mm SunFire C18 OBD Prep Column, 100Å, 5 µm, 30 x 100 mm
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[ CARE AND USE MANUAL ] Austria and European Export (Central South Eastern Europe, CIS and Middle East) 43 1 877 18 07 Australia 61 2 9933 1777 Belgium 32 2 726 1000 Brazil 55 11 4134 3788 Canada 1 800 252 4752 China 86 21 6156 2666 Czech Republic 420 2 617 11384 Denmark 45 46 59 8080 Finland 358 9 5659 6288 France 33 1 30 48 72 00 Germany 49 6196 400 600 Hong Kong 852 2964 1800 Hungary 36 1 350 5086 Norway 47 6 384 6050 Poland 48 22 101 5900 Puerto Rico 1 787 747 8445 Russia/CIS 7 495 727 4490/ 290 9737