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PHR1059

Omeprazole

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, Antra, Losec

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About This Item

Empirical Formula (Hill Notation):
C17H19N3O3S
CAS Number:
73590-58-6
Molecular Weight:
345.42
NACRES:
NA.24
PubChem Substance ID:
329823089
UNSPSC Code:
41116107
MDL number:
MFCD00083192

Key Documents

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Product Name

Omeprazole, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C17H19N3O3S/c1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17/h5-8H,9H2,1-4H3,(H,19,20)

SMILES string

COc1ccc2[nH]c(nc2c1)S(=O)Cc3ncc(C)c(OC)c3C

InChI key

SUBDBMMJDZJVOS-UHFFFAOYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. O0150000
traceable to USP 1478505

API family

omeprazole

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

forensics and toxicology
pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

Gene Information

human ... ATP4A(495), ATP4B(496)

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.

Application

Omeprazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations using spectrophotometric technique and high-performance liquid chromatography technique.
Omeprazole may be used as a reference standard in the determination of omeprazole in pharmaceutical formulations using high performance thin layer chromatography (HPTLC).
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.

General description

Omeprazole is a benzimidazole drug, which exhibits antisecretory and antiulcer properties. It is widely used in the treatment of duodenal, gastric ulcers, reflux oesophagitis and against other acid-related diseases.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAC0716 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation markEnvironment
GHS07,GHS09

signalword

Warning

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 2 - Skin Sens. 1

Storage Class

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Extractive spectrophotometric determination of omeprazole in pharmaceutical preparations
Bhandage A, et al.
Tropical Journal of Pharmaceutical Research, 8(5), 1133-1142 (2009)
A validated HPTLC method for determination of ondansetron in combination with omeprazole or rabeprazole in solid dosage form
Raval.B.P, et al.
Indian Journal of Pharmaceutical Sciences, 70(3), 386-386 (2008)
Spectrophotometric determination of omeprazole, lansoprazole and pantoprazole in pharmaceutical formulations
Wahbi AAM, et al.
Journal of Pharmaceutical and Biomedical Analysis, 30(4), 1133-1142 (2002)
A validated normal phase HPLC method for simultaneous determination of drotaverine hydrochloride and omeprazole in pharmaceutical formulation
Topagi SK, et al.
Asian Journal of Pharmaceutical and Clinical Research, 3(1), 20-24 (2010)
Jason Y Park et al.
PloS one, 9(7), e101391-e101391 (2014-07-06)
Besides reducing gastric acid secretion, proton pump inhibitors (PPIs) suppress Th2-cytokine-stimulated expression of an eosinophil chemoattractant (eotaxin-3) by esophageal epithelial cells through acid-independent, anti-inflammatory mechanisms. To explore acid-inhibitory and acid-independent, anti-inflammatory PPI effects in reducing esophageal eosinophilia, we studied eotaxin-3
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