Description

Omeprazole Ep Impurity F is a specified impurity used in the analytical profiling and quality control of Omeprazole, a widely prescribed proton pump inhibitor. This reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial monographs. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Omeprazole Ep Impurity F in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with International Conference on Harmonisation (ICH) guidelines and pharmacopeial specifications (EP, USP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Omeprazole to minimize impurity formation.

Basic Information

Product Name	Omeprazole Ep Impurity F
CAS No.	125656-82-8
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 F; Omeprazole Impurity F; 5-Methoxy-1H-benzimidazole-2-thiol, 1-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-; 1-[[(4-Methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole-2-thiol; Omeprazole Related Compound F; European Pharmacopoeia Omeprazole Impurity F
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry 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 requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.