Description

Pantoprazole n-Oxide is a key pharmaceutical intermediate and impurity standard in the synthesis and quality control of the proton pump inhibitor pantoprazole. Its precise characterization is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). This compound is primarily required by manufacturers and analytical laboratories in the pharmaceutical and fine chemical industries for research, development, and rigorous quality assurance processes.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of Pantoprazole sodium sesquihydrate, the active ingredient in anti-ulcer medications.
• Reference Standard (Impurity): Used as a certified reference material (CRM) in HPLC and LC-MS methods to identify, quantify, and control the n-Oxide impurity in Pantoprazole API and finished dosage forms.
• Process Development & Optimization: Employed in research to study metabolic pathways, degradation profiles, and to optimize synthesis routes to minimize this specific impurity.
• Quality Control & Assurance: Essential for analytical laboratories to validate methods, calibrate equipment, and ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.

Basic Information

Product Name	Pantoprazole n-Oxide
CAS No.	953787-60-5
Molecular Formula	C16H14F2N3O5S
Molecular Weight	398.36 g/mol
Synonyms	Pantoprazole N-Oxide; Pantoprazole Impurity N-Oxide; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole 1-Oxide; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-, 1-oxide; Pantoprazole Related Compound N-Oxide; Pantoprazole Sulfoxide N-Oxide
EINECS	Contact for details

Quality Control

Our Pantoprazole n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets stringent specifications for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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