Description

Lafutidine Impurity 10 is a specified impurity of the pharmaceutical active ingredient Lafutidine, a histamine H2-receptor antagonist. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Lafutidine Impurity 10 in Lafutidine drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QA/QC testing to monitor impurity profiles and ensure batches meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) dossiers by providing impurity characterization data.
• Research & Development: Aids in synthetic route optimization and impurity profiling during the drug development process.

Basic Information

Product Name	Lafutidine Impurity 10
CAS No.	154923-16-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lafutidine Related Compound 10; Lafutidine EP Impurity J; Lafutidine USP Impurity; 2-[(2-Furanylmethyl)thio]-N-[[4-[[4-(piperidin-1-ylmethyl)pyridin-2-yl]oxy]-(Z)-2-butenyl]methyl]acetamide Impurity; Lafutidine Degradation Product; Lafutidine Process Impurity
EINECS	Contact for details

Quality Control

Our Lafutidine Impurity 10 is manufactured under GMP-compliant conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. The quality management system adheres to ICH Q7 and ISO 9001 standards, providing full traceability and documentation for regulatory audits.

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 under inert atmosphere or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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