Description

Esomeprazole Impurity 99 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 within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods for Esomeprazole API.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring final drug product meets pharmacopeial specifications (e.g., USP, EP).
• Research & Development (R&D): Essential for impurity identification, characterization, and pathway studies during API synthesis process development and optimization.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing necessary impurity data for drug approval.
• Stability Studies: Employed as a marker to track the formation of degradation products in Esomeprazole formulations under various stress conditions.
• Method Development: A key component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity separation and analysis.

Basic Information

Product Name	Esomeprazole Impurity 99
CAS No.	1831938-48-7
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Esomeprazole Related Compound 99; Esomeprazole EP Impurity 99; Esomeprazole USP Impurity 99; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 99; Esomeprazole Sulfoxide Impurity; Esomeprazole Process Impurity; Esomeprazole Degradant
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Impurity 99 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and structural identity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your regulatory and quality requirements.

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 must be kept in a desiccated environment to maintain stability and purity.

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)	Individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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