Description

Omeprazole Impurity F (Ep), also known as 2,12-Dihydro-1,3-dimethyl-8-methoxy-12-thioxobenzo[4,5]pyrido[1,2-c]imidazo[1,2-a]imidazol-2-one, is a high-purity reference standard of a specified impurity related to the active pharmaceutical ingredient Omeprazole. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by enabling accurate identification and quantification of impurities during drug development and manufacturing. It is an essential material for analytical laboratories, quality control departments, and research institutions in the global pharmaceutical industry focused on compliance with pharmacopeial monographs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Omeprazole Impurity F as per European Pharmacopoeia (EP) specifications.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to ensure product purity and compliance.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• 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 ICH guidelines.
• Research & Development: Used in impurity isolation, characterization studies, and synthetic pathway investigation during API process development.

Basic Information

Product Name	Omeprazole Impurity F (Ep): 2,12-Dihydro-1,3-Dimethyl-8-Methoxy-12-Thioxobenzo[4,5]Pyrido[1,2-C]Imidazo[1,2-A]Imidazol-2-One Mm Standard
CAS No.	2748245-58-9
Molecular Formula	C₁₇H₁₄N₄O₂S
Molecular Weight	338.38 g/mol
Synonyms	Omeprazole Impurity F EP; Omeprazole Related Compound F; 1,3-Dimethyl-8-methoxy-12-thioxobenzo[4,5]pyrido[1,2-c]imidazo[1,2-a]imidazol-2(12H)-one; Benzo[4,5]pyrido[1,2-c]imidazo[1,2-a]imidazol-2-one, 2,12-dihydro-1,3-dimethyl-8-methoxy-12-thioxo-; Omeprazole Sulfenamide Derivative; Omeprazole EP Impurity F; Omeprazole Sulfenic Acid Amide Analog
EINECS	Contact for details

Quality Control

This high-grade reference standard is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including orthogonal methods for identity confirmation and purity assessment, to ensure it meets the exacting requirements for pharmacopeial impurity standards. A detailed Certificate of Analysis (CoA) is provided, which includes batch-specific data on purity, chromatographic profile, and results from all applicable tests. Our quality protocols are designed to support GMP/GLP compliance for our customers in regulated markets.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. This material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.