Description

Nafamostatmesylate Impurity 1 is a designated impurity of the pharmaceutical active ingredient Nafamostat Mesylate. This compound is critical for analytical research and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Nafamostat Mesylate drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, used in stability studies and release testing.
• Quality Control & Assurance (QC/QA): Used in routine batch analysis to monitor impurity profiles and ensure compliance with strict pharmacopeial standards (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during synthesis, helping to optimize manufacturing processes for higher purity.

Basic Information

Product Name	Nafamostatmesylate Impurity 1
CAS No.	97457-78-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nafamostat Impurity 1; Nafamostat Mesylate Related Compound 1; 6-Amidino-2-naphthyl 4-guanidinobenzoate Impurity; FUT-175 Impurity 1; Guanidinobenzoic Acid Derivative Impurity
EINECS	Contact for details

Quality Control

Our Nafamostatmesylate Impurity 1 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed batch-specific results are provided and traceable to primary standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specified limits
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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