Description

Vonoprazan Fumarate Impurity 89 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 (API) Vonoprazan Fumarate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Vonoprazan Fumarate API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control and Assurance (QC/QA): Essential for in-house quality control laboratories to ensure API purity complies with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as part of drug product stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in R&D to study the degradation pathways and chemistry of Vonoprazan Fumarate.

Basic Information

Product Name	Vonoprazan Fumarate Impurity 89
CAS No.	1224739-02-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-amine fumarate; Vonoprazan Related Compound 89; Vonoprazan Fumarate Related Substance 89; TA-2711 Impurity; TAK-438 Impurity; 1H-Pyrrole-3-amine, 5-(2-fluorophenyl)-1-(3-pyridinylsulfonyl)-, (2E)-2-butenedioate (1:1)
EINECS	Contact for details

Quality Control

Our Vonoprazan Fumarate Impurity 89 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), 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.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under 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%

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