Description

Esomeprazole Related Substance H431/41 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization, method validation, and quality control of the active pharmaceutical ingredient (API) Esomeprazole. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify related substances in Esomeprazole API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, calibrating, and validating chromatographic methods to meet ICH Q2(R1) guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) and Batch Release Testing: An indispensable tool for in-house QC laboratories to verify the purity and specification of Esomeprazole batches against pharmacopeial standards (USP, EP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Academic and Clinical Research: Supports metabolic studies, pharmacokinetic research, and other investigative work on proton pump inhibitors.

Basic Information

Product Name	Esomeprazole Related Substance H431/41
CAS No.	1227380-90-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Esomeprazole Impurity H431/41; Esomeprazole Related Compound H431/41; (S)-Omeprazole Related Substance H431/41; Esomeprazole Specified Impurity; Esomeprazole Process Impurity; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Related Substance; H 431/41
EINECS	Contact for details

Quality Control

Our Esomeprazole Related Substance H431/41 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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)	≥ 98.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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