Description

Lafutidine Impurity 4 CAS NO 169899-16-5 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Lafutidine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by serving as a benchmark for impurity identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) focused on developing and manufacturing H2-receptor antagonist drugs.

Application

• Primary use as a certified reference standard for the identification and quantification of related substances in Lafutidine API.
• Critical component in method development and validation for chromatographic assays (e.g., HPLC, UPLC).
• Essential for stability studies and degradation pathway analysis of Lafutidine formulations.
• Used in pharmacopoeial testing to comply with regulatory standards (e.g., ICH Q3A/B, USP, EP).
• Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data.
• Valuable for academic and clinical research investigating the metabolism and pharmacokinetics of Lafutidine.

Basic Information

Product Name	Lafutidine Impurity 4
CAS No.	169899-16-5
Molecular Formula	C22H29N3O4S
Molecular Weight	431.55 g/mol
Synonyms	Lafutidine Related Compound 4; 2-[(2-Furanylmethyl)sulfinyl]-N-[[4-[[4-(piperidinomethyl)-2-pyridinyl]oxy]-(Z)-2-butenyl]acetamide; UNII-0J8V7V3K7T; Lafutidine Impurity D; Lafutidine EP Impurity D; Lafutidine USP Impurity D; Lafutidine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lafutidine Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure compliance with pharmacopoeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.