Description

Esomeprazole Impurity 95 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Esomeprazole, a widely prescribed proton pump inhibitor. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for analytical chemists, quality assurance laboratories, and R&D departments within the pharmaceutical and fine chemical industries.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Esomeprazole Impurity 95 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Esomeprazole and related compounds.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Esomeprazole.
• Essential for regulatory compliance and submission to agencies like the FDA, EMA, and ICH, requiring thorough impurity profiling.
• Serves as a research tool in synthetic chemistry for studying the formation and mitigation of specific process-related impurities.
• Supports quality control (QC) and quality assurance (QA) protocols in pharmaceutical manufacturing to ensure batch-to-batch consistency.

Basic Information

Product Name	Esomeprazole Impurity 95
CAS No.	125656-80-6
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Esomeprazole Related Compound 95; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, (S)- (Impurity); Esomeprazole Sulfoxide Impurity; Esomeprazole EP Impurity G; Potential degradation product of Esomeprazole
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Impurity 95 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including those referenced in pharmacopeial monographs. Comprehensive characterization is performed using advanced techniques like HPLC, LC-MS, NMR, and IR. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, 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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.