Description

Desdifluoromethoxy Hydroxy Pantoprazole is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of pantoprazole, a widely prescribed proton pump inhibitor. This high-purity compound is critical for ensuring the efficacy, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in drug development, process optimization, and rigorous quality assurance testing.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Pantoprazole Sodium Sesquihydrate, the active pharmaceutical ingredient.
• Reference Standard: Used as a certified impurity standard for HPLC and other analytical methods to monitor and control the purity of pantoprazole API.
• Process Research & Development (R&D): Employed in route scouting, process optimization, and scale-up studies for pantoprazole manufacturing.
• Analytical Method Development: Serves as a critical component for developing and validating stability-indicating assay methods.
• Quality Control & Assurance (QC/QA): Essential for identity confirmation, assay, and impurity profiling in accordance with ICH guidelines.
• Regulatory Submissions: Provides necessary data and standards for drug master files (DMFs) and regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	Desdifluoromethoxy Hydroxy Pantoprazole
CAS No.	1261238-06-5
Molecular Formula	C16H14F2N3O4S
Molecular Weight	382.36 g/mol
Synonyms	Pantoprazole Impurity; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; Desfluoro Pantoprazole Sulfoxide; Pantoprazole Related Compound; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-; Pantoprazole EP Impurity; Pantoprazole USP Impurity
EINECS	Contact for details

Quality Control

Our Desdifluoromethoxy Hydroxy Pantoprazole is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets stringent specifications for use as a pharmaceutical intermediate and reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with relevant pharmacopeial guidelines (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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
Loss on Drying	≤ 0.5%

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