Description

Lafutidine Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lafutidine. This compound is critical for ensuring the purity, safety, and efficacy of Lafutidine-based pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lafutidine API and finished drug products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor degradation pathways.
• Quality Control & Assurance: A critical component in routine QC testing to ensure Lafutidine batches meet stringent pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to identify and track impurity formation under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control.
• Research & Development: Used in R&D laboratories to study the synthesis pathways, degradation mechanisms, and metabolic profiles of Lafutidine.

Basic Information

Product Name	Lafutidine Impurity 4
CAS No.	1348637-58-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lafutidine Related Compound 4; Lafutidine EP Impurity D; Lafutidine USP Impurity 4; Lafutidine Process Impurity; 2-[(2-Furanylmethyl)sulfinyl]-N-[[4-[[4-(piperidin-1-ylmethyl)pyridin-2-yl]oxy]but-2E-enyl]acetamide Impurity; Lafutidine Specified Impurity
EINECS	Contact for details

Quality Control

Our Lafutidine Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

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

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