Description

n-[(3,4-Dimethoxy-2-Pyridinyl)Methyl] Pantoprazole Sulfone is a key pharmaceutical intermediate and impurity standard used in the development and quality control of proton pump inhibitor drugs. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) like pantoprazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug synthesis, method validation, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of pantoprazole and related proton pump inhibitor APIs.
• Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify related substances in drug substances and products.
• Process Development: Employed in route scouting and optimization studies for the manufacturing of pantoprazole.
• Quality Control (QC): Essential for establishing and validating impurity profiles in accordance with ICH Q3A and Q3B guidelines.
• Regulatory Compliance: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in metabolic studies, stability testing, and degradation pathway analysis of pantoprazole.

Basic Information

Product Name	n-[(3,4-Dimethoxy-2-Pyridinyl)Methyl] Pantoprazole Sulfone
CAS No.	1797132-60-5
Molecular Formula	C18H19FN4O5S
Molecular Weight	422.43 g/mol
Synonyms	Pantoprazole Sulfone Impurity; Pantoprazole EP Impurity G; Pantoprazole Related Compound G; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sulfone; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfonyl]-; Pantoprazole Sulfoxide Impurity; n-[(3,4-Dimethoxy-2-pyridyl)methyl] Pantoprazole Sulfone
EINECS	Contact for details

Quality Control

Our n-[(3,4-Dimethoxy-2-Pyridinyl)Methyl] Pantoprazole Sulfone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support specific pharmacopeial (USP, EP) or internal method requirements.

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 under appropriate conditions to maintain stability.

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: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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