Description

Rabeprazole n-Oxide is a key pharmaceutical intermediate and impurity standard in the synthesis and quality control of the proton pump inhibitor Rabeprazole. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, process optimization, and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of the active pharmaceutical ingredient (API) Rabeprazole Sodium.
• Reference Standard: Used as a certified impurity standard in HPLC and other analytical methods for quality control of Rabeprazole API and finished dosage forms.
• Process Research & Development (R&D): Employed in route scouting, optimization studies, and impurity profiling during the development of Rabeprazole manufacturing processes.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require characterization and control of process-related impurities.
• Analytical Method Validation: Serves as a system suitability and specificity test compound in the validation of stability-indicating assay methods.
• Academic & Contract Research: Utilized in pharmacological and metabolic studies to understand the degradation pathways and stability profile of Rabeprazole.

Basic Information

Product Name	Rabeprazole n-Oxide
CAS No.	924663-38-7
Molecular Formula	C18H20N3O4S
Molecular Weight	374.44 g/mol
Synonyms	Rabeprazole N-Oxide; Rabeprazole Impurity F; Rabeprazole Related Compound F; 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole 1-Oxide; Pariet Impurity F; 1H-Benzimidazole, 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-, 1-oxide
EINECS	Contact for details

Quality Control

Our Rabeprazole n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and control of related substances, to ensure it meets the stringent requirements for pharmaceutical impurity standards. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

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

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 guidelines
Loss on Drying	≤ 0.5%

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