Description

Lafutidine Impurity 7 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Lafutidine. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and development scientists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Lafutidine API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect related substances.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research & Synthesis: Serves as an intermediate or marker in process chemistry research to optimize synthesis pathways and minimize impurity formation.

Basic Information

Product Name	Lafutidine Impurity 7
CAS No.	169899-17-6
Molecular Formula	C22H29N3O4S
Molecular Weight	431.55 g/mol
Synonyms	2-[(2-Furanylmethyl)sulfinyl]-N-[[4-[[4-(piperidin-1-ylmethyl)-2-pyridinyl]oxy]butyl]carbamimidoyl]acetamide; Lafutidine Related Compound 7; Lafutidine EP Impurity G; Lafutidine USP Impurity; 1-Piperidineacetamide, N-[[4-[[4-[(1-piperidinyl)methyl]-2-pyridinyl]oxy]butyl]amino]carbonimidoyl]-2-(2-furanylmethyl)sulfinyl]-; UNII-7V7P8F8Q4H
EINECS	Contact for details

Quality Control

Every batch of Lafutidine Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results from advanced analytical techniques. We support GMP-oriented applications and can supply materials suitable for regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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.