Description

Someprazole Impurity 19 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Esomeprazole, a widely prescribed proton pump inhibitor. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and efficacy. The availability of this well-characterized impurity is essential for method validation and meeting stringent regulatory compliance standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Esomeprazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels against ICH guidelines.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Esomeprazole.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing robust purification processes.

Basic Information

Product Name	Someprazole Impurity 19
CAS No.	358675-51-1
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	Esomeprazole Impurity 19; (S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Related Compound; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; Esomeprazole EP Impurity I; Esomeprazole USP Related Compound; Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-; A potential degradation product of Esomeprazole
EINECS	Contact for details

Quality Control

Every batch of Someprazole Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

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 light-sensitive; ensure the container is kept tightly sealed 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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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