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Merck
CN

PHR1648

奥美拉唑砜

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

Omeprazole sulfone, 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfonyl]-1H-benzimidazole, 5-Methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfonyl}-1H-benzimidazole, Omeprazole sulphone

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关于此项目

经验公式(希尔记法):
C17H19N3O4S
化学文摘社编号:
分子量:
361.42
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
MDL number:
Beilstein/REAXYS Number:
8347309
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InChI key

IXEQEYRTSRFZEO-UHFFFAOYSA-N

SMILES string

O=S(C1=NC2=CC(OC)=CC=C2N1)(CC3=NC=C(C)C(OC)=C3C)=O

InChI

1S/C17H19N3O4S/c1-10-8-18-15(11(2)16(10)24-4)9-25(21,22)17-19-13-6-5-12(23-3)7-14(13)20-17/h5-8H,9H2,1-4H3,(H,19,20)

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. O0151000, traceable to USP 1478516

API family

omeprazole

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

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General description

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.

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.

It is an impurity of the substituted benzimidazole― omeprazole, that belongs to the class of proton pump inhibitors (PPIs). Omeprazole inhibits the secretion of gastric juice by inhibiting the activity of the enzyme H+/K+-ATPase (Hydrogen-Potassium Adenosine Triphosphates). Hence it is used widely for the treatment of diseases caused by excess secretion of gastric juices.

Application

This pharmaceutical secondary standard can also be used as follows:

  • Analysis of omeprazole tablets for the separation and detection of omeprazole and its related impurities by reversed-phase high-performance liquid chromatographic (RP-HPLC) method
  • Determination of omeprazole and its 11 related impurities in pharmaceutical formulations by RP-HPLC method based on quality-by-design approach (QbD)
  • Development of an ultra-high performance liquid chromatography-time of flight-mass spectrometry (UHPLC-TOF-MS) based method to estimate omeprazole and its related impurities in pharmaceutical formulations
  • Separation and detection of omeprazole and its metabolites in human urine samples by capillary zone electrophoresis (CZE) combined with UV-Visible detector
  • Estimation of related impurities of omeprazole and domperidone in their combined dosage form using the RP-HPLC method

Analysis Note

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

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.
To see an example of a Certificate of Analysis for this material enter LRAC3168 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation markEnvironment

signalword

Warning

hcodes

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 2

存储类别

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable


分析证书(COA)

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Development and Validation of a Precise single HPLC Method for Determination of Omeprazole and its related compound in pharmaceutical formulation
Trivedi HK and Patel MC
International Journal of ChemTech Research, 2, 1355-1367 (2010)

商品

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

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