Description

Omeprazole Impurity 36 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, quantification, and control of process-related impurities during the manufacturing of Omeprazole, a widely prescribed proton pump inhibitor. It is an essential tool for analytical chemists and quality control professionals dedicated to ensuring drug safety and regulatory compliance. The primary users are pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Omeprazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Used as a critical standard to develop, optimize, and validate analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Acts as a marker to track the formation of degradation products in Omeprazole under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Utilized in synthetic chemistry research to understand impurity formation pathways and to develop purer synthetic routes for Omeprazole.

Basic Information

Product Name	Omeprazole Impurity 36
CAS No.	151602-50-5
Molecular Formula	C₁₇H₁₉N₃O₃S
Molecular Weight	345.42 g/mol
Synonyms	5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 36; Omeprazole Related Compound 36; 5-Methoxy-1H-benzimidazole-2-thiol, 1-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-; UNII-7K3I3V275J; 1-[[(4-Methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole-2-thiol
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Impurity 36 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if prolonged storage is required.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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