PHR1648

Omeprazole Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 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
• Empirical Formula (Hill Notation): C₁₇H₁₉N₃O₄S
• CAS Number: 88546-55-8
• Molecular Weight: 361.42
• Beilstein/REAXYS Number: 8347309
• MDL number: MFCD00869772
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823531
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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
• 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)
• InChI key: IXEQEYRTSRFZEO-UHFFFAOYSA-N

Description

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, EP and BP primary standards, where they are available.

Footnote

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.

Recommended products

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Safety Information

• pictograms: GHS07,GHS09
• signalword: Warning
• hcodes: H302,H411
• pcodes: P264 - P270 - P273 - P301 + P312 - P391 - P501
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Chronic 2
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 2
• flash_point_f: Not applicable
• flash_point_c: Not applicable