Description

Vonoprazan Fumarate Impurity is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Vonoprazan Fumarate by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for identifying and quantifying this specific impurity in Vonoprazan Fumarate API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions to establish shelf-life and storage requirements.
• Research & Development (R&D): Facilitates process chemistry research aimed at understanding and minimizing impurity formation during API synthesis.

Basic Information

Product Name	Vonoprazan Fumarate Impurity
CAS No.	1885094-62-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vonoprazan Fumarate Related Compound; Vonoprazan Fumarate Process Impurity; Vonoprazan Fumarate Specified Impurity; TA-2711 Impurity; TAK-438 Impurity; Potassium-Competitive Acid Blocker (P-CAB) Impurity; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine Fumarate Impurity
EINECS	Contact for details

Quality Control

Our Vonoprazan Fumarate Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
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%

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