Description

Fasudil Impurity 5 is a designated impurity standard of the pharmaceutical compound Fasudil, a Rho-kinase (ROCK) inhibitor. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of Fasudil-based drug products through comprehensive analytical profiling. It is an essential tool for pharmaceutical R&D and quality control laboratories engaged in method development, validation, and stability studies. The compound is supplied with full analytical characterization to support regulatory filings and maintain stringent quality standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Fasudil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Stability Studies & Degradation Profiling: Employed to monitor the formation of Fasudil Impurity 5 under various stress conditions (e.g., heat, light, humidity) as part of ICH stability-indicating methods.
• Quality Control & Batch Release: A critical component in the quality control workflow to ensure that Fasudil API and drug products meet predefined impurity specifications and pharmacopeial limits.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data required for drug approval.
• Research on Metabolic Pathways: Can be utilized in research settings to study the degradation pathways and related substances of Fasudil.

Basic Information

Product Name	Fasudil Impurity 5
CAS No.	2044702-91-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fasudil Related Compound 5; Fasudil Impurity; 5-Isoquinolinesulfonamide, 1-[(5-isoquinolinyl)sulfonyl]hexahydro-, hydrochloride; Hexahydro-1-(5-isoquinolinylsulfonyl)-1H-1,4-diazepine hydrochloride; HA-1077 Impurity; AT877 Impurity; (Hexahydro-1-(5-isoquinolinylsulfonyl)-1H-1,4-diazepine) hydrochloride
EINECS	Contact for details

Quality Control

Our Fasudil Impurity 5 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the requirements for reference standards used in cGMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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