Description

Fasudil Impurity 1 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Fasudil, a Rho-kinase inhibitor. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical manufacturing and contract research organizations (CROs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances 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.
• Stability Studies: Employed as a marker to monitor the formation of degradation products during forced degradation and long-term stability testing of Fasudil formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and purity of the API.
• Research on Degradation Pathways: Used in research settings to study the chemical degradation pathways and metabolism of Fasudil.

Basic Information

Product Name	Fasudil Impurity 1
CAS No.	1423155-03-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fasudil Related Compound 1; 1-(5-Isoquinolinesulfonyl)homopiperazine Impurity 1; HA-1077 Impurity 1; AT877 Impurity 1; (Hexahydro-1H-1,4-diazepin-1-yl)(5-isoquinolinyl)methanone Impurity; Fasudil Hydrochloride Impurity 1; 5-Isoquinolinesulfonamide, N-(hexahydro-1H-1,4-diazepin-1-yl)-, Impurity
EINECS	Contact for details

Quality Control

Our Fasudil Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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