Description

Esomeprazole Impurity 26 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) esomeprazole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in research and development, method validation, and stability studies for proton pump inhibitor drugs.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Esomeprazole API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical quality control laboratories.
• Supports stability studies and forced degradation studies to monitor impurity profiles over time.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Critical for pharmaceutical research to understand the degradation pathways and synthesis by-products of esomeprazole.
• Serves as a key reagent in calibration and system suitability testing for chromatographic assays.

Basic Information

Product Name	Esomeprazole Impurity 26
CAS No.	704910-88-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Esomeprazole Related Compound 26; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 26; 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; PPI Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Impurity 26 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods and purity determination by chromatographic techniques. Certificates of Analysis (COA) with detailed chromatographic data, including retention time and relative response factor, are available upon request to support your regulatory and analytical needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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