Description

Pantoprazole Sulfone n-Oxide is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of pantoprazole, a widely prescribed proton pump inhibitor. 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 validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC and LC-MS analysis in pantoprazole API and finished product quality control.
• Process Chemistry Research: Serves as a critical intermediate or marker in the study and optimization of pantoprazole synthesis pathways.
• Method Development & Validation: Essential for developing and validating analytical methods to monitor and control related substances in compliance with ICH guidelines.
• Regulatory Documentation: Supports the preparation of regulatory filings (e.g., DMF, CMC sections) by providing characterized impurity profiles.
• Stability Studies: Employed to identify and quantify degradation products in pantoprazole formulations under various stress conditions.
• Academic & Contract Research: Used in universities and CROs for pharmacological and metabolic studies related to proton pump inhibitors.

Basic Information

Product Name	Pantoprazole Sulfone n-Oxide
CAS No.	953787-55-8
Molecular Formula	C16H14F2N3O5S
Molecular Weight	398.36 g/mol
Synonyms	Pantoprazole Sulfone N-Oxide; Pantoprazole Impurity F (EP); Pantoprazole EP Impurity F; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sulfone N-Oxide; BY1023 Sulfone N-Oxide; Pantoprazole Related Compound F; Pantoprazole Sulfoxide Impurity; SK&F96022 Sulfone N-Oxide
EINECS	Contact for details

Quality Control

Our Pantoprazole Sulfone n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided to support your quality and regulatory 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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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