Description

Fasudil Impurity 1 Hcl 2 is a high-purity chemical reference standard, specifically identified as an impurity of the pharmaceutical agent Fasudil Hydrochloride. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing, ensuring product safety and regulatory compliance. It is primarily utilized by research institutions, quality control laboratories, and API manufacturers involved in the development and production of Rho-kinase (ROCK) inhibitors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Fasudil Hydrochloride Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed as a marker to track degradation pathways and assess the shelf-life of Fasudil formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to global health authorities (FDA, EMA, PMDA).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the fate of this specific impurity in biological systems.

Basic Information

Product Name	Fasudil Impurity 1 Hcl 2
CAS No.	166895-76-7
Molecular Formula	C14H17N3O2S • HCl
Molecular Weight	335.83 g/mol
Synonyms	Fasudil Related Compound 1; 5-(1,4-Diazepan-1-ylsulfonyl)isoquinoline Hydrochloride; HA-1077 Impurity 1; AT877 Impurity 1; (1,4-Diazepan-1-ylsulfonyl)isoquinoline Hydrochloride; 5-[(Hexahydro-1H-1,4-diazepin-1-yl)sulfonyl]isoquinoline Hydrochloride; Fasudil HCl Impurity A
EINECS	Contact for details

Quality Control

Every batch of Fasudil Impurity 1 Hcl 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept under inert conditions or in a desiccator after opening 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 individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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