Description

Vonoprazan Impurity 3 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Vonoprazan. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Vonoprazan API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry research to minimize impurity formation.

Basic Information

Product Name	Vonoprazan Impurity 3
CAS No.	928325-41-1
Molecular Formula	C17H16FN3O2S
Molecular Weight	345.39 g/mol
Synonyms	1-(5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Vonoprazan Related Compound 3; Vonoprazan EP Impurity C; Vonoprazan USP Impurity; Vonoprazan Process Impurity; Potassium-Competitive Acid Blocker (P-CAB) Impurity
EINECS	Contact for details

Quality Control

Every batch of Vonoprazan Impurity 3 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert conditions when necessary to ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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