PHR1648

Omeprazole Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(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
• Formule empirique (notation de Hill): C₁₇H₁₉N₃O₄S
• Numéro CAS: 88546-55-8
• Poids moléculaire : 361.42
• Numéro Beilstein : 8347309
• Numéro MDL: MFCD00869772
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823531
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. O0151000; traceable to USP 1478516
• Famille d'API: omeprazole
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 30 mg
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-8°C
• Chaîne SMILES: 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)
• Clé InChI: IXEQEYRTSRFZEO-UHFFFAOYSA-N

Description

Description générale

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

Remarque sur l'analyse

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

Note de bas de page

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.

Produits recommandés

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.

Informations sur la sécurité

• Pictogrammes: GHS07,GHS09
• Mention d'avertissement: Warning
• Mentions de danger: H302,H411
• Conseils de prudence: P264 - P270 - P273 - P301 + P312 - P391 - P501
• Classification des risques: Acute Tox. 4 Oral - Aquatic Chronic 2
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 2
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable