Description

Lafutidine Impurity B is a specified impurity of the active pharmaceutical ingredient Lafutidine, a histamine H2-receptor antagonist. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical standards to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of Lafutidine Impurity B in Lafutidine API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for impurity profiling.
• Used in pharmaceutical quality control (QC) and quality assurance (QA) laboratories to monitor and control impurity levels.
• Essential for stability studies to track impurity formation under various storage conditions.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing impurity characterization data.
• Utilized in research and development to study the degradation pathways and chemistry of Lafutidine.

Basic Information

Product Name	Lafutidine Impurity B
CAS No.	174583-84-7
Molecular Formula	C22H29N3O4S
Molecular Weight	431.55 g/mol
Synonyms	Lafutidine Related Compound B; 2-[(2-Furanylmethyl)sulfinyl]-N-[[4-[[4-(piperidinomethyl)-2-pyridinyl]oxy]butyl]amino]carbonyl]acetamide; N-[[4-[[4-(Piperidinomethyl)-2-pyridinyl]oxy]butyl]carbamoyl]-2-(2-furanylmethylsulfinyl)acetamide; Lafutidine EP Impurity B; Lafutidine USP Impurity B; Lafutidine Impurity B (EP); Lafutidine Impurity B (USP)
EINECS	Contact for details

Quality Control

Our Lafutidine Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and major pharmacopoeial standards (USP, EP).

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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