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PHR1987

Omeprazole Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

2-[(RS)-[(3,5-Dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole, 2-[(RS)-[(3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-5-methoxy-1h-benzimidazole, 2-[[(3,5-Dimethyl-2-pyridinyl)methyl]sulfinyl]--6-methoxy-1H-benzimidazol, 4-Desmethoxy Omeprazole

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About This Item

Empirical Formula (Hill Notation):
C16H17N3O2S
CAS Number:
110374-16-8
Molecular Weight:
315.39
UNSPSC Code:
41116107
NACRES:
NA.24
Beilstein/REAXYS Number:
6573983
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

API family

omeprazole

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

[S](=O)(Cc3ncc(cc3C)C)c1[nH]c2c(n1)ccc(c2)OC

InChI

1S/C16H17N3O2S/c1-10-6-11(2)15(17-8-10)9-22(20)16-18-13-5-4-12(21-3)7-14(13)19-16/h4-8H,9H2,1-3H3,(H,18,19)

InChI key

ZMXZYNHJPJEPAE-UHFFFAOYSA-N

General description

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. Omeprazole Impurity B is found to be as an impurity of omeprazole. Omeprazole is a benzimidazole derivative, which is widely used as an antiulcer drug and against other acid-related diseases.

Application

Olmesartan medoxomil may be used as a pharmaceutical secondary standard for the determination of the analyte in pharmaceutical formulations using different analytical techniques.
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 and EP 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.
To see an example of a Certificate of Analysis for this material enter LRAB4099 in the Documents 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 Irrit. 2

Storage Class

11 - Combustible Solids

wgk

WGK 3

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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Articles

Determination of Omeprazole and Related Compounds

The Ascentis® Express 120 Å C18 pH+ column delivers high efficiency, stable retention, and reliable peak performance under alkaline mobile phase conditions.

Extractive spectrophotometric determination of omeprazole in pharmaceutical preparations
Bhandage A, et al.
Tropical Journal of Pharmaceutical Research, 8(5), 544-549 (2009)
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)

Global Trade Item Number

SKUGTIN
PHR1987-30MG04061822419742