Description

Vonoprazan Fumarate Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient, Vonoprazan Fumarate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material to identify, quantify, and monitor this specific impurity during the manufacturing and quality control of Vonoprazan Fumarate API.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Stability Studies and Forced Degradation: Employed in comparative studies to understand degradation pathways and establish the stability-indicating nature of analytical procedures.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Quality Assurance/Quality Control (QA/QC): Used as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to ensure product specifications are met.
• Research and Development: Supports R&D activities aimed at process optimization, impurity synthesis, and understanding structure-activity relationships.

Basic Information

Item	Detail
Product Name	Vonoprazan Fumarate Impurity 6
CAS No.	2250243-23-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vonoprazan Fumarate Related Compound 6; Vonoprazan Impurity 6; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine Fumarate Impurity; TA-2711 Impurity; TAK-438 Impurity; Fumaric acid salt of Vonoprazan Impurity
EINECS	Contact for details

Quality Control

Every batch of Vonoprazan Fumarate Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC and LC-MS to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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