Description

Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) used as an active pharmaceutical ingredient (API). It offers a differentiated mechanism of action for the effective treatment of acid-related gastrointestinal disorders. This compound is essential for pharmaceutical manufacturers developing next-generation therapies for conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Its stability profile under recommended storage conditions ensures reliable performance in formulation development.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for acid suppression.
• GERD Treatment: Formulation into tablets or capsules for the management of gastroesophageal reflux disease.
• Peptic Ulcer Therapy: Used in drugs aimed at healing and preventing gastric and duodenal ulcers.
• Helicobacter pylori Eradication: A key component in combination therapy regimens for H. pylori infection.
• Research & Development: Serves as a reference standard and building block in pharmacological and clinical research.
• Formulation Development: Used in pre-formulation studies and the development of solid dosage forms.

Basic Information

Product Name	Vonoprazan
CAS No.	881681-00-1
Molecular Formula	C17H16FN3O2S
Molecular Weight	345.39 g/mol
Synonyms	TAK-438; Vonoprazan Fumarate (salt form); 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine; Potassium-Competitive Acid Blocker; P-CAB; (1-[5-(2-Fluorophenyl)-1-(pyridine-3-sulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine)
EINECS	Contact for details

Quality Control

Our Vonoprazan is manufactured under strict quality management systems to ensure it meets the high standards required for pharmaceutical use. Each batch is tested against rigorous specifications for identity, purity, and potency. A comprehensive Certificate of Analysis (COA) is provided, detailing results from tests including assay, related substances, residual solvents, and heavy metals. We support compliance with ICH guidelines and relevant pharmacopeial standards.

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 light-sensitive; containers must be kept tightly sealed in a dry environment to prevent degradation and absorption of moisture.

Specification

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

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