[ CARE AND USE MANUAL ]
MetID STANDARD MIX
CONTENTS
I. INTRODUCTION
II. STORAGE & STABILITY
III. RECONSTITUTION OF THE STANDARD
SOLUTION FOR TESTING
IV. EXAMPLE OF USING OMEPRAZOLE STANDARD MIX
V. ORDERING INFORMATION
VI. REFERENCES
I. INTRODUCTION
Omeprazole Metabolite Mix is used to test and demonstrate the
Waters UNIFI Application Solution for Metabolite Identification.
The standard was designed to both test and confirm LC and MS
performance but also to test and demonstrate the UNIFI system
solution. Omeprazole is a commonly prescribed medication used to treat
acid reflux causing heartburn (known clinically as gastroesophageal
reflux disease, GERD). When the compound is dosed in vivo in human,
two of the commonly detected metabolites which are formed in
human are 5-hydroxy omeprazole and omeprazole sulfone.
O
N
H
S
O
Omeprazole
O
N
H
S
O
5-Hydroxy Omeprazole
N
N
OH
O
Figure 1. Structures of Omeprazole, 5-Hydroxy Omeprazole, and Omeprazole Sulfone
N
N
O
N
OO
H
S
O
Omeprazole Sulfone
N
N
O
MetID Standard Mix 1
Using Waters ACQUIT Y UPLC® BEH column chemistry, the generic
gradient method can be used to analyze and effectively separate the
standard into its parent and 2 authentic metabolite standard components.
The standard mix stock solution comprises Omeprazole, 5-hydroxy
omeprazole and omeprazole sulfone at concentrations of 10, 1 and
0.1 µg/mL respectively.
II. Storage and Stability.
The lyophilized powder is shipped at ambient temperatures, in brown
amber vials in foil packaging. It is highly recommended that upon
receipt, the standard should be stored frozen and thawed before use.
Once reconstituted the sample should be used immediately for
best results. Omeprazole has been reported to be unstable in the
presence of continuous exposure to UV. Care should be taken to prepare
samples and standard curves out of direct light whenever possible. If
[ CARE AND USE MANUAL ]
moderate precautions are taken and the samples, once reconstituted,
are stored properly at -10°C (and analyzed within an autosampler
set to 10°C or lower) the standard is typically stable for at least one
week. Beyond this time for performance testing and evaluation, fresh
re-preparation of the standard is recommended.
III. Reconstitution of the standard solution for testing
1. To the vial of Lyophilized Waters MetID Standard Mix, add 1 mL
of Methanol.
2. Recap and then agitate the vial contents (e.g. via shaking or
ultrasonic bath), to ensure the lyophilized powder dissolves in
the methanol.
3. This standard can be further diluted as per the UNIFI
Metabolite Identification Test Protocol, which documents
formal standard curve, PDA and UNIFI system performance
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testing.
IV. Example of Using Omeprazole Standard Mix
V. ORDERING INFORMATION
To order these products, contact your nearest subsidiary, or visit
www. waters.com and click on Order Center.
Description Part number
MetID Standard Mix 186006550
Formic Acid 186006691
VI. References
1
Metabolite Identific ation Application Solution Quick Start P/N 715003759.
2
Maton, P.N., Ome prazole Review Article, N. Engl J Med 1991; 324:965-975.
Shown in figure 2 is a representative chromatogram under standard
chromatography conditions.
Figure 2. Omeprazole Standard Mix (33.3 ng/mL) extracted
ion chromatogram acquired on an ACQUITY U PLC I-Class
coupled to a Xevo® G2-S QTof Mass Spectrometer System
and processed using UNIFI Scientific Information System.
MetID Standard Mix 2
[ CARE AND USE MANUAL ]
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November 2012 720004501EN Rev A IH-PDF
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