Description

Pantoprazole Impurity 1 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Pantoprazole. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify this specific impurity in Pantoprazole drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Pantoprazole analysis.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Pantoprazole batches meet stringent pharmacopeial (USP, EP) or internal specification limits for impurities.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Academic and Clinical Research: Supports investigative studies on the metabolism, pharmacokinetics, and toxicological significance of Pantoprazole-related compounds.

Basic Information

Product Name	Pantoprazole Impurity 1
CAS No.	812664-93-0
Molecular Formula	C16H14F2N3O4S
Molecular Weight	382.36 g/mol
Synonyms	Pantoprazole Impurity A; Pantoprazole Related Compound A; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-; Pantoprazole Sulfoxide; Pantoprazole EP Impurity A; Pantoprazole USP Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Pantoprazole Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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