Description

Esomeprazole Impurity CAS NO 1424857-86-2 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) esomeprazole. It is an essential tool for researchers, analytical chemists, and quality assurance professionals working in pharmaceutical R&D, contract manufacturing organizations (CMOs), and regulatory testing laboratories.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the development and manufacturing of Esomeprazole API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to confirm that esomeprazole batches meet stringent pharmacopeial (USP, EP, JP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies and Forced Degradation: Acts as a marker in stability-indicating assays to track impurity formation under various stress conditions (heat, light, humidity, acid/base).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Reference Standard: Used in academic and industrial research to study the chemical properties, formation pathways, and toxicological profiles of esomeprazole-related substances.

Basic Information

Product Name	Esomeprazole Impurity
CAS No.	1424857-86-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Esomeprazole Related Compound; Esomeprazole Process Impurity; Esomeprazole Specified Impurity; (S)-Omeprazole Impurity; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; Nexium Impurity; Perprazole Impurity
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Impurity (CAS 1424857-86-2) 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 they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). The container should be kept in a desiccator or under an inert atmosphere if the compound is moisture-sensitive. For long-term storage, consider freezing at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.