Description

Vonoprazan Impurity 32 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 the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of potassium-competitive acid blocker (P-CAB) medications.

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 stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure batches meet stringent pharmacopeial (e.g., USP, EP, JP) specifications.
• Stability Studies: Used to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, MAA) to health authorities like the FDA and EMA.
• Research & Development: Supports impurity isolation, identification, and toxicological studies during the drug development lifecycle.

Basic Information

Product Name	Vonoprazan Impurity 32
CAS No.	881733-45-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vonoprazan Related Compound 32; Vonoprazan EP Impurity 32; Vonoprazan USP Impurity 32; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine impurity; TAK-438 Impurity 32; PCAB Impurity; Potassium-Competitive Acid Blocker Impurity
EINECS	Contact for details

Quality Control

Every batch of Vonoprazan Impurity 32 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference standard. 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 in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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