Description

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

Application

• Pharmaceutical API: Core active ingredient in prescription medications for acid suppression therapy.
• Gastroesophageal Reflux Disease (GERD) Treatment: Formulated into tablets or capsules for managing chronic heartburn and esophageal damage.
• Peptic Ulcer Disease Therapy: Used in formulations to promote healing of gastric and duodenal ulcers.
• Helicobacter pylori Eradication: A key component in combination therapy regimens to eliminate H. pylori infection.
• Pharmaceutical Research & Development: Serves as a reference standard and building block in preclinical and clinical studies for new gastrointestinal drugs.
• Formulation Development: Used in the development of various solid oral dosage forms, including controlled-release formulations.

Basic Information

Product Name	Vonoprazan Fumarate
CAS No.	1260141-27-2
Molecular Formula	C21H20FN3O2S • C4H4O4
Molecular Weight	585.60 g/mol
Synonyms	TAK-438 Fumarate; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine fumarate; Vonoprazan Fumarate Salt; Vonoprazan Hemifumarate; (1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine) fumarate; TAK438
EINECS	Contact for details

Quality Control

Our Vonoprazan Fumarate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. A Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC assay, related substances, residual solvents, and heavy metals. We support compliance with cGMP, ICH guidelines, and relevant pharmacopeial standards.

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. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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