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Key Documents

PHR1059

Supelco

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:
Molecular Weight:
345.42
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 765
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

SMILES string

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

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)

InChI key

SUBDBMMJDZJVOS-UHFFFAOYSA-N

Gene Information

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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.

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.

Analysis Note

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

Other Notes

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.

Footnote

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.

Recommended products

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.

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Pictograms

Exclamation markEnvironment

Signal Word

Warning

Hazard Statements

Hazard Classifications

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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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)
R P Myers et al.
The American journal of gastroenterology, 96(12), 3428-3431 (2002-01-05)
Omeprazole is a proton pump inhibitor that is used commonly in the treatment of acid-peptic disorders. Although omeprazole is generally well tolerated, serious adverse effects such as renal failure have been reported. Thus far, 17 cases of acute interstitial nephritis

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