Description

Lafutidine Impurity 1 CAS NO 169899-18-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the development and manufacturing of the active pharmaceutical ingredient (API) Lafutidine. It is primarily required by pharmaceutical R&D laboratories, quality assurance (QA) departments, and contract research organizations (CROs) to ensure product purity, safety, and efficacy.

Application

• Pharmaceutical Impurity Profiling and Identification in Lafutidine API development.
• Method Development and Validation for HPLC, UPLC, and other chromatographic techniques.
• Quality Control (QC) and Stability Testing of Lafutidine drug substances and finished products.
• Regulatory Submission and Compliance (e.g., for ICH guidelines Q3A(R2) and Q3B(R2)).
• Calibration Standard for analytical instrumentation in laboratory settings.
• Research Reference Material for pharmacokinetic and metabolic studies.

Basic Information

Product Name	Lafutidine Impurity 1
CAS No.	169899-18-7
Molecular Formula	C22H29N3O4S
Molecular Weight	431.55 g/mol
Synonyms	2-(Furan-2-ylmethylsulfinyl)-N-[[4-[[4-(piperidin-1-ylmethyl)pyridin-2-yl]oxy]but-2-yn-1-yl]acetamide; Lafutidine Related Compound A; Lafutidine EP Impurity A; Lafutidine USP Impurity; UNII-8V8K8F8Q8R; 2-[(Furan-2-ylmethyl)sulfinyl]-N-[(4-{[4-(piperidin-1-ylmethyl)pyridin-2-yl]oxy}but-2-yn-1-yl)]acetamide
EINECS	Contact for details

Quality Control

Our Lafutidine Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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