Description

Esomeprazole Related Substance H193/61 is a high-purity chemical reference standard used in pharmaceutical development and quality control. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of esomeprazole-based drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for precise impurity profiling and method validation.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in esomeprazole active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and for setting impurity acceptance criteria during routine QC testing of esomeprazole.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required for drug master files (DMF), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of esomeprazole.

Basic Information

Product Name	Esomeprazole Related Substance H193/61
CAS No.	784143-42-6
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Esomeprazole Impurity H193/61; Esomeprazole Related Compound H193/61; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Related Substance H193/61; Esomeprazole Sulfone N-Oxide; Esomeprazole Sulfoxide Impurity; Proton Pump Inhibitor Related Substance
EINECS	Contact for details

Quality Control

Every batch of Esomeprazole Related Substance H193/61 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity, structural confirmation, and quantitative assay. A detailed Certificate of Analysis (COA) is supplied with each lot, containing results from validated methods such as HPLC, NMR, and MS. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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); ensure the container is kept tightly sealed in a low-humidity environment to maintain 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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