Description

Dexlansoprazole Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Dexlansoprazole, a widely used proton pump inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity and safety. The availability of a well-characterized impurity standard is essential for method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dexlansoprazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Dexlansoprazole.

Basic Information

Product Name	Dexlansoprazole Impurity 6
CAS No.	1409978-52-4
Molecular Formula	C16H14F3N3O2S
Molecular Weight	369.36 g/mol
Synonyms	Dexlansoprazole Related Compound 6; Dexlansoprazole EP Impurity 6; Dexlansoprazole USP Impurity 6; Dexlansoprazole Degradation Product; 2-[[[4-(2,2,2-Trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole Impurity; Dexlansoprazole Sulfoxide Impurity; (RS)-Dexlansoprazole Sulfoxide
EINECS	Contact for details

Quality Control

Every batch of Dexlansoprazole Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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