Description

Fasudil Impurity 8 is a designated impurity 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) during development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Fasudil Impurity 8 in Fasudil API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure API batches meet stringent purity specifications as per ICH guidelines.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Fasudil.

Basic Information

Product Name	Fasudil Impurity 8
CAS No.	1935078-12-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fasudil Related Compound 8; 1-(5-Isoquinolinesulfonyl)homopiperazine Impurity 8; HA-1077 Impurity 8; AT877 Impurity 8; (E)-1-(5-Isoquinolinesulfonyl)homopiperazine; Potential isomer or derivative of Fasudil
EINECS	Contact for details

Quality Control

Every batch of Fasudil Impurity 8 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.