Description

Lafutidine Impurity 9 CAS NO 1339863-11-4 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Lafutidine through rigorous impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory compliance teams involved in the development and manufacturing of Lafutidine-based formulations.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Lafutidine API.
• Method Development and Validation in analytical laboratories for HPLC, LC-MS, and related techniques.
• Quality Control & Assurance to monitor and control impurity levels during Lafutidine manufacturing processes.
• Regulatory Compliance & Documentation for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies to track impurity formation in Lafutidine drug products under various storage conditions.
• Research & Development for studying the degradation pathways and chemical behavior of Lafutidine.

Basic Information

Product Name	Lafutidine Impurity 9
CAS No.	1339863-11-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lafutidine Related Compound 9; Lafutidine EP Impurity I; Lafutidine USP Impurity; 2-[(2-Furanylmethyl)sulfinyl]-N-[[4-[[4-(piperidin-1-ylmethyl)pyridin-2-yl]oxy]but-2E-enyl]acetamide Impurity; Lafutidine Degradation Product; Lafutidine Process Impurity; Lafutidine Specified Impurity
EINECS	Contact for details

Quality Control

Our Lafutidine Impurity 9 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is characterized and tested using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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