Description

Pantoprazole Impurity 59 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, quantification, and control of process-related impurities in the active pharmaceutical ingredient (API) Pantoprazole, ensuring drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting compliance with stringent regulatory guidelines for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Pantoprazole.
• Method Development and Validation: Crucial for developing and validating analytical methods, particularly HPLC and LC-MS, for impurity detection.
• Quality Control & Assurance: Used in QC labs to monitor and control the levels of this specific impurity during Pantoprazole API manufacturing.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed in forced degradation and long-term stability studies of Pantoprazole drug products to track impurity formation.
• Research & Development: Serves as a key intermediate or impurity marker in chemical process optimization and synthesis pathway research.

Basic Information

Product Name	Pantoprazole Impurity 59
CAS No.	562074-62-8
Molecular Formula	C16H15F2N3O4S
Molecular Weight	383.37 g/mol
Synonyms	5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; Pantoprazole Related Compound 59; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-; Pantoprazole Sulfone N-Oxide (potential isomer); Pantoprazole EP Impurity I; Pantoprazole USP Related Compound; BY1023 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pantoprazole Impurity 59 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to client specifications.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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