Description

Esomeprazole Impurity 25 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) esomeprazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The reliable identification and quantification of this impurity are essential for maintaining the highest standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Esomeprazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of analytical procedures.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to monitor the formation of degradation products in Esomeprazole under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's behavior and toxicological profile.

Basic Information

Product Name	Esomeprazole Impurity 25
CAS No.	1080689-87-7
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Esomeprazole Related Compound 25; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 25; Esomeprazole EP Impurity K; Esomeprazole USP Related Compound; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, (S)-, Impurity; Esomeprazole Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Impurity 25 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use under GMP conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.