Description

Omeprazole Sulfone n-Oxide is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of proton pump inhibitors. This compound is critical for ensuring the purity, safety, and efficacy of related active pharmaceutical ingredients (APIs) by serving as a reference marker for oxidative degradation pathways. It is primarily utilized by research institutions, analytical laboratories, and manufacturers within the global pharmaceutical and fine chemical sectors for method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analytical testing of Omeprazole and related APIs.
• Process Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in pharmaceutical R&D.
• Stability Indicating Method: Acts as a critical marker in forced degradation studies to monitor the stability profile of proton pump inhibitor drugs.
• Quality Control & Assurance: Employed in in-process control and final release testing to quantify sulfone n-oxide impurities.
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Academic & Contract Research: Serves as a reagent in pharmacological and metabolic pathway research studies.

Basic Information

Product Name	Omeprazole Sulfone n-Oxide
CAS No.	158812-85-2
Molecular Formula	C₁₇H₁₉N₃O₅S
Molecular Weight	377.42 g/mol
Synonyms	Omeprazole N-Oxide Sulfone; Omeprazole Sulfone N-Oxide; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole 1-Oxide; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, 1-oxide; Omeprazole Impurity L (EP); Omeprazole Impurity 10 (USP); Omeprazole Related Compound L
EINECS	Contact for details

Quality Control

Our Omeprazole Sulfone n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets stringent specifications for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support compliance with USP, EP, ICH, and other relevant pharmaceutical guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.