Description

Esomeprazole Impurity 17 is a high-purity chemical reference standard used in the analytical profiling of Esomeprazole, a widely prescribed proton pump inhibitor. This impurity is critical for pharmaceutical research and development, enabling precise identification, quantification, and control of related substances to ensure drug safety and efficacy. It is an essential material for quality control laboratories, regulatory affairs, and R&D teams in the pharmaceutical industry focused on method validation, stability studies, and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Esomeprazole Impurity 17 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Stability and Forced Degradation Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity, acid/base hydrolysis) to establish product shelf-life.
• Quality Control and Batch Release: Serves as a system suitability and identification standard in routine QC testing to ensure Esomeprazole batches meet specified impurity limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Supports testing against monograph specifications in USP, EP, or other pharmacopoeias where this impurity is listed or controlled.

Basic Information

Product Name	Esomeprazole Impurity 17
CAS No.	2101206-41-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Esomeprazole Related Compound 17; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 17; Esomeprazole EP Impurity I; Esomeprazole USP Related Compound; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, (S)-, Impurity; Esomeprazole Specified Impurity
EINECS	Contact for details

Quality Control

Our Esomeprazole Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH Q3A/B guidelines for impurities in new drug substances and products.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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% w/w

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