Description

Vonoprazan Fumarate is a high-potency potassium-competitive acid blocker (P-CAB) API used in the treatment of acid-related gastrointestinal disorders. Its primary value lies in its rapid, potent, and long-lasting suppression of gastric acid secretion, offering a significant therapeutic advantage. This compound is essential for pharmaceutical manufacturers developing next-generation treatments for conditions like gastroesophageal reflux disease (GERD), peptic ulcers, and Helicobacter pylori infections.

Application

• Pharmaceutical Active Ingredient (API): Core component in solid oral dosage forms such as tablets and capsules for acid suppression therapy.
• Gastroesophageal Reflux Disease (GERD) Treatment: Formulated for medications targeting erosive esophagitis and symptomatic GERD.
• Peptic Ulcer Disease Therapy: Used in formulations for the healing and prevention of gastric and duodenal ulcers.
• Helicobacter Pylori Eradication: A key agent in combination therapy regimens for the eradication of H. pylori infection.
• Research & Development: Serves as a critical reference standard and building block in preclinical and clinical research for new gastrointestinal drugs.
• Formulation Development: Used in stability studies, bioavailability enhancement, and the development of novel drug delivery systems.

Basic Information

Product Name	Vonoprazan Fumarate
CAS No.	881681-01-2
Molecular Formula	C21H20FN3O2S • C4H4O4
Molecular Weight	581.61 g/mol
Synonyms	TAK-438 Fumarate; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine fumarate; Vonoprazan Fumarate (1:1); Vonoprazan Hydrogen Fumarate; Potassium-Competitive Acid Blocker (P-CAB); TAK-438 (fumarate salt)
EINECS	Contact for details

Quality Control

Our Vonoprazan Fumarate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, residual solvent analysis, and stringent microbiological controls, to ensure it meets high-purity pharmacopeial standards. A detailed Certificate of Analysis (COA) is provided with every shipment to guarantee traceability, consistency, and regulatory compliance for your pharmaceutical applications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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