Description

Pantoprazole Impurity 5 (CAS 1806469-15-7) is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pantoprazole. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and monitor this specific impurity, ensuring drug safety and compliance with stringent regulatory guidelines. It is primarily used in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pantoprazole Impurity 5 in Pantoprazole API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to confirm impurity levels are within International Council for Harmonisation (ICH) and pharmacopeial limits (USP, EP).
• Stability Studies: Used to monitor the formation and growth of this impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Pantoprazole, supporting formulation optimization.

Basic Information

Product Name	Pantoprazole Impurity 5
CAS No.	1806469-15-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pantoprazole Related Compound 5; Pantoprazole EP Impurity C; Pantoprazole USP Impurity; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]- (Related Substance); Pantoprazole Sulfoxide Impurity; BY1023 Impurity
EINECS	Contact for details

Quality Control

Our Pantoprazole Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 must be kept in a desiccated environment to maintain stability and purity.

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 unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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