Description

Vonoprazan Impurity 84 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Vonoprazan, a potassium-competitive acid blocker (P-CAB). This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and contract research organization (CRO) sectors for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Vonoprazan API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release: A critical component in routine QC testing to ensure API and drug product batches meet stringent pharmacopeial (e.g., ICH Q3A/B) and internal specification limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the main API.

Basic Information

Product Name	Vonoprazan Impurity 84
CAS No.	2358783-64-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vonoprazan Related Compound 84; Vonoprazan Impurity CRS; 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine impurity; TA-2711 Impurity; TAK-438 Impurity; Vonoprazan Degradant; Vonoprazan Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Vonoprazan Impurity 84 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting regulatory needs and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

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

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