Description

Vonoprazan-050-C4H4O4 is a high-purity pharmaceutical intermediate, specifically a salt form of the active pharmaceutical ingredient Vonoprazan. This compound is critical for ensuring the stability, bioavailability, and consistent performance of the final drug product. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of next-generation acid suppression therapies.

Application

• Pharmaceutical Intermediate: Key building block in the synthesis of Vonoprazan Fumarate, a potassium-competitive acid blocker (P-CAB) used in anti-ulcer medications.
• Active Pharmaceutical Ingredient (API) Manufacturing: Serves as a direct precursor in the final salt formation and purification steps for API production under GMP conditions.
• Research & Development: Used in preclinical and clinical studies to investigate pharmacokinetics, stability, and formulation of new gastroesophageal reflux disease (GERD) treatments.
• Formulation Development: Employed in the development of solid oral dosage forms such as tablets and capsules, ensuring consistent drug delivery.
• Reference Standard: High-purity batches are utilized as analytical reference standards for quality control and regulatory testing.
• Process Chemistry: Integral to scale-up and optimization of synthetic routes in pilot plants and commercial manufacturing facilities.

Basic Information

Product Name	Vonoprazan-050-C4H4O4
CAS No.	928325-69-3
Molecular Formula	C17H16FN3O2S • C4H4O4
Molecular Weight	461.46 g/mol
Synonyms	1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine fumarate; Vonoprazan Fumarate; TAK-438 Fumarate; (1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine) (2E)-But-2-enedioate; Vonoprazan Fumarate Salt; Vonoprazan Hemifumarate; Potassium-Competitive Acid Blocker Intermediate; P-CAB Intermediate
EINECS	Contact for details

Quality Control

Our Vonoprazan-050-C4H4O4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, residual solvent analysis, and identification by IR and NMR, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to support regulatory filings for GMP, ICH Q7, and other global compliance 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 under dry, inert conditions to maintain stability and potency.

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)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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