Description

Vonoprazan Impurity U2 Fumaric Acid is a high-purity reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Vonoprazan. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring product safety and regulatory compliance. It is an essential material for research and development scientists, quality assurance laboratories, and manufacturers within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vonoprazan Impurity U2 in drug substances and products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during Vonoprazan synthesis.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Vonoprazan API meets stringent pharmacopeial (e.g., USP, EP, JP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability testing programs.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Vonoprazan synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Vonoprazan Impurity U2 Fumaric Acid
CAS No.	2416241-96-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vonoprazan Fumarate Impurity U2; Vonoprazan Related Compound U2; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine Fumarate; TAK-438 Impurity U2 Fumarate; (1-[5-(2-Fluorophenyl)-1-(pyridine-3-sulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine) (E)-But-2-enedioate; Vonoprazan Fumaric Acid Adduct Impurity
EINECS	Contact for details

Quality Control

Every batch of Vonoprazan Impurity U2 Fumaric Acid is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical reference material users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identification by spectroscopic methods, and residual solvent analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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