Description

Omeprazole N1-Methyl 6-Methoxy Thiol Impurity is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of omeprazole, a widely used proton pump inhibitor, by enabling the accurate identification and quantification of this specific process-related impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams involved in the development and manufacturing of omeprazole and related drug substances.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the N1-Methyl 6-Methoxy Thiol impurity in omeprazole active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with International Council for Harmonisation (ICH) Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Utilized as an analytical marker in forced degradation and long-term stability studies to understand the degradation pathways of omeprazole.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Omeprazole N1-Methyl 6-Methoxy Thiol Impurity
CAS No.	1526768-06-8
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Omeprazole Impurity 11; Omeprazole N1-Methyl Thiol Impurity; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]thio]-1H-benzimidazole N1-Methyl Derivative; 1-Methyl-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]thio]-1H-benzimidazole; Omeprazole Related Compound J; Omeprazole Process Impurity; 1526768-06-8
EINECS	Contact for details

Quality Control

Every batch of Omeprazole N1-Methyl 6-Methoxy Thiol Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, confirming its suitability for use as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to 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
Water Content (KF)	≤ 0.5% w/w

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