Description

Esomeprazole Impurity 23 is a high-purity reference standard used in the analytical development and quality control of the active pharmaceutical ingredient (API) esomeprazole. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of esomeprazole-based pharmaceutical products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in esomeprazole API and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring product consistency.
• Stability Studies: Employed to track the formation of degradation products in esomeprazole under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development (R&D): Supports process chemistry research aimed at understanding and minimizing impurity formation during API synthesis.

Basic Information

Product Name	Esomeprazole Impurity 23
CAS No.	1422063-97-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Esomeprazole Related Compound 23; Esomeprazole EP Impurity J; Esomeprazole USP Impurity; 5-Methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzo[d]imidazole Impurity; (S)-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

Our Esomeprazole Impurity 23 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for APIs and ICH guidelines (Q3A, Q6A) on impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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