Description

Pantoprazole Ep Impurity E is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient Pantoprazole sodium sesquihydrate. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specified impurities in Pantoprazole drug substances and products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the impurity levels during the manufacturing process of Pantoprazole.
• Stability Studies: Essential for conducting forced degradation and long-term stability studies to understand the degradation pathways of Pantoprazole.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to comply with FDA, EMA, and other global health authority requirements.
• Research and Development (R&D): Used in pharmaceutical R&D to study the synthesis pathways, degradation mechanisms, and overall purity of Pantoprazole.

Basic Information

Product Name	Pantoprazole Ep Impurity E
CAS No.	2115779-15-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pantoprazole Impurity E; Pantoprazole Related Compound E; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; Pantoprazole Sulfoxide Impurity; Pantoprazole EP Impurity E; Pantoprazole USP Related Compound E; Pantoprazole Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Pantoprazole Ep Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (EP/BP, USP) and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability and purity.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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