Description

Fasudil n-Hydroxy Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Fasudil, a Rho-kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in Fasudil API and related drug products.
• Analytical Reference Standard for method development and validation in HPLC, LC-MS, and other chromatographic systems.
• Quality Control (QC) and Quality Assurance (QA) testing to monitor and control impurity levels during manufacturing.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Stability Studies to track the formation and behavior of this specific degradation product over time.
• Research and Development (R&D) of Fasudil and its derivatives, including metabolic and pharmacokinetic studies.

Basic Information

Product Name	Fasudil n-Hydroxy Impurity
CAS No.	1350827-92-7
Molecular Formula	C14H17N3O2S
Molecular Weight	291.37 g/mol
Synonyms	Fasudil Hydroxy Impurity; Fasudil Related Compound; 5-(1,4-Diazepan-1-ylsulfonyl)isoquinolin-7-ol; n-Hydroxy Fasudil; HA-1077 n-Hydroxy Impurity; HA-1077 Related Substance; AT877 n-Hydroxy Impurity
EINECS	Contact for details

Quality Control

Our Fasudil n-Hydroxy Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B guidelines and cGMP standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle with appropriate personal protective equipment in a well-ventilated laboratory setting.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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