Description

Vonoprazan Impurity 24 is a designated process-related impurity of the active pharmaceutical ingredient Vonoprazan, a potassium-competitive acid blocker (P-CAB). This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Vonoprazan-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Vonoprazan API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and analyze related substances.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure API meets stringent pharmacopeial (e.g., USP, EP, JP) specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides essential 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 synthetic pathway of Vonoprazan to minimize the formation of this specific impurity.

Basic Information

Product Name	Vonoprazan Impurity 24
CAS No.	1807642-41-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vonoprazan Related Compound 24; TA-2711 Impurity 24; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine Impurity; Vonoprazan EP Impurity I; Vonoprazan Process Impurity; Vonoprazan Degradant
EINECS	Contact for details

Quality Control

Every batch of Vonoprazan Impurity 24 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results against established specifications. Our quality standards align with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. For long-term storage, consider storing desiccated at -20°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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