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O-048

Supelco

Omeprazole Impurity Mixture solution

60 μg/mL in acetonitrile (each component), certified reference material, ampule of 1 mL, Cerilliant®

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About This Item

Empirical Formula (Hill Notation):
C17H19N3O5S
Molecular Weight:
377.41
UNSPSC Code:
12352200
NACRES:
NA.24

grade

certified reference material

form

liquid

feature

Snap-N-Spike®/Snap-N-Shoot®

packaging

ampule of 1 mL

manufacturer/tradename

Cerilliant®

concentration

60 μg/mL in acetonitrile (each component)

technique(s)

gas chromatography (GC): suitable
liquid chromatography (LC): suitable

application(s)

pharmaceutical (small molecule)

format

multi-component solution

storage temp.

−20°C

General description

Omeprazole belongs to the class of drugs called proton pump inhibitors (PPIs). It is generally prescribed to prevent gastrointestinal bleeding associated with widely used aspirin-clopidogrel antiplatelet dual therapy as part of antithrombotic therapy. It can also be used as prophylactic treatment as well as for the healing of ulcers associated with nonsteroidal anti-inflammatory drugs (NSAIDs).[1][2][3]

Application

Omeprazole Impurity Mixture solution may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.[4]
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Legal Information

CERILLIANT is a registered trademark of Merck KGaA, Darmstadt, Germany
Snap-N-Shoot is a registered trademark of Cerilliant Corporation
Snap-N-Spike is a registered trademark of Merck KGaA, Darmstadt, Germany

Analyte

Description
    Omeprazole Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material
    Omeprazole Related Compound E, Pharmaceutical Secondary Standard; Certified Reference Material
    Omeprazole Related Compound I, Pharmaceutical Secondary Standard; Certified Reference Material
    Omeprazole, Pharmaceutical Secondary Standard; Certified Reference Material

pictograms

FlameExclamation mark
GHS02,GHS07

signalword

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2

Storage Class

3 - Flammable liquids

wgk_germany

WGK 2

flash_point_f

35.6 °F - closed cup

flash_point_c

2.0 °C - closed cup

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Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs
Hawkey CJ, et al.
The New England Journal of Medicine, 338(11), 727-734 (1998)
Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study
Gilard M, et al.
Journal of the American College of Cardiology, 51(3), 256-260 (2008)
Omeprazole
USP42-NF37
United States Pharmacopeia/National Formulary, 38(3), 3223-3223 (2018)
Clopidogrel with or without omeprazole in coronary artery disease
Bhatt DL, et al.
The New England Journal of Medicine, 363(20), 1909-1917 (2010)

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