Description

Fasudil Impurity 9 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical agent Fasudil. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a known benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a critical benchmark for the identification and quantification of impurities in Fasudil API during HPLC and related analytical methods.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods for Fasudil drug substances and products.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency of Fasudil, complying with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry research by identifying and characterizing process-related impurities.

Basic Information

Product Name	Fasudil Impurity 9
CAS No.	25448-76-4
Molecular Formula	C14H17N3O2S
Molecular Weight	291.37 g/mol
Synonyms	5-(1,4-Diazepan-1-ylsulfonyl)isoquinoline; HA-1100; 1-(5-Isoquinolinesulfonyl)homopiperazine; Fasudil Related Compound 9; 1-(Isoquinoline-5-sulfonyl)hexahydro-1H-1,4-diazepine; AT877 Impurity 9; ERIL Impurity 9
EINECS	Contact for details

Quality Control

Our Fasudil Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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