Description

Vonoprazan Impurity 2 is a specified impurity of the active pharmaceutical ingredient Vonoprazan, a potassium-competitive acid blocker used in the treatment of acid-related disorders. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Vonoprazan-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Vonoprazan active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with pharmacopeial standards (e.g., ICH Q3A/B, USP, EP) for impurity limits.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability testing of drug formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Vonoprazan to minimize the formation of this impurity.

Basic Information

Product Name	Vonoprazan Impurity 2
CAS No.	881733-36-4
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 2; Vonoprazan EP Impurity B; Vonoprazan USP Impurity; TAK-438 Impurity 2; (1-(5-(2-Fluorophenyl)-1-(pyridine-3-sulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine)
EINECS	Contact for details

Quality Control

Every batch of Vonoprazan Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including purity, chromatographic data, and structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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. For long-term storage, consider storing under an inert atmosphere.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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