Description

Fasudil Impurity 3 CAS NO 166895-80-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Fasudil, a Rho-kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for meeting stringent regulatory requirements in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fasudil API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing of raw materials, in-process samples, and final drug products to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and levels of this specific degradation product during forced degradation and long-term stability studies of Fasudil.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and metabolic pathway studies related to Rho-kinase inhibitors.

Basic Information

Product Name	Fasudil Impurity 3
CAS No.	166895-80-3
Molecular Formula	C14H17N3O2S
Molecular Weight	291.37 g/mol
Synonyms	1-(5-Isoquinolinesulfonyl)homopiperazine; Hexahydro-1-(5-isoquinolinesulfonyl)-1H-1,4-diazepine; HA-1100; HA 1100; HA1100; Fasudil Related Compound 3; Fasudil EP Impurity C; Fasudil Hydrochloride Impurity 3
EINECS	Contact for details

Quality Control

Every batch of Fasudil Impurity 3 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment. We support compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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 light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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