Description

Esomeprazole Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Esomeprazole, a widely prescribed proton pump inhibitor. It serves as a key marker for identification and quantification of specific impurities during pharmaceutical development and manufacturing. Quality control laboratories, R&D facilities, and regulatory bodies require this standard to comply with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Esomeprazole-related impurities in compliance with ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Esomeprazole API and finished dosage forms to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Critical for preparing drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the impurity profile.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Esomeprazole Impurity 1
CAS No.	1384163-92-1
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Esomeprazole Impurity A; Esomeprazole Related Compound 1; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 1; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, (S)-, Impurity; Esomeprazole EP Impurity A; Esomeprazole USP Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening to ensure compliance with pharmacopeial standards (USP, EP, CP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substances, residual solvents, and other relevant tests.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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