Description

Dexlansoprazole Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in Dexlansoprazole drug substances and finished products. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance for proton pump inhibitor medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Used in HPLC, UPLC, and LC-MS analyses to identify and quantify Impurity 7 in Dexlansoprazole Active Pharmaceutical Ingredients (APIs) and formulations.
• Method Development & Validation: Serves as a critical component in developing and validating stability-indicating assay methods as per ICH Q2(R1) guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data required for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Dexlansoprazole.
• Research & Development: Facilitates process chemistry research aimed at minimizing the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Dexlansoprazole Impurity 7
CAS No.	1781244-56-1
Molecular Formula	C16H14F3N3O2S
Molecular Weight	369.36 g/mol
Synonyms	Dexlansoprazole Related Compound 7; Dexlansoprazole EP Impurity G; Dexlansoprazole USP Impurity; 2-[[[4-(2,2,2-Trifluoroethoxy)-2-pyridinyl]methyl]thio]-1H-benzimidazole N-Oxide; Dexlansoprazole Sulfoxide; Dexlansoprazole S-Oxide; Dexlansoprazole Oxidation Impurity
EINECS	Contact for details

Quality Control

Every batch of Dexlansoprazole Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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