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PHR1987

Supelco

Omeprazole Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
2-[[(3,5-Dimethyl-2-pyridinyl)methyl]sulfinyl]--6-methoxy-1H-benzimidazol, 4-Desmethoxy Omeprazole, 2-[(RS)-[(3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-5-methoxy-1h-benzimidazole, 2-[(RS)-[(3,5-Dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole
Empirical Formula (Hill Notation):
C16H17N3O2S
CAS Number:
Molecular Weight:
315.39
Beilstein:
6573983
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

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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, EP 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 LRAB4099 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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)

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