Description

Esomeprazole Impurity 3 is a designated impurity 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 purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the proton pump inhibitor drug. This high-purity reference standard is essential for meeting stringent pharmacopeial requirements in the global pharmaceutical industry.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Esomeprazole API and finished dosage forms.
• Essential for method development and validation of analytical procedures (e.g., HPLC, UPLC) in quality control laboratories.
• Critical component in stability studies to monitor impurity profiles and degradation pathways of Esomeprazole under various storage conditions.
• Used in regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and specifications as per ICH Q3A and Q3B guidelines.
• Supports pharmaceutical research for process optimization and impurity characterization during API synthesis.
• Employed by contract research organizations (CROs) and testing laboratories for third-party quality assurance and batch release testing.

Basic Information

Product Name	Esomeprazole Impurity 3
CAS No.	1346599-85-6
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Esomeprazole Related Compound 3; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 3; Esomeprazole Sulfone N-Oxide; Esomeprazole EP Impurity C; Esomeprazole USP Related Compound C; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, 1-oxide, (S)-; Esomeprazole Oxidation Impurity
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Impurity 3 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity confirmation, and impurity profiles as determined by validated analytical methods such as HPLC and NMR. We ensure traceability and batch-to-batch consistency for reliable results in your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

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 unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0% - 102.0%

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