Description

Fasudil Impurity 13 is a designated impurity standard of the pharmaceutical agent Fasudil, a Rho-kinase inhibitor. This high-purity reference material is critical for analytical method development, validation, and ensuring the quality and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in the research, development, and production of Fasudil and related therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Fasudil API and its formulations.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing to monitor and control impurity levels, ensuring compliance with ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity identification and characterization data.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's behavior and relevance.

Basic Information

Product Name	Fasudil Impurity 13
CAS No.	748752-50-3
Molecular Formula	C14H17N3O2S2
Molecular Weight	323.43 g/mol
Synonyms	5-(1,4-Diazepan-1-ylsulfonyl)isoquinoline; Fasudil Related Compound 13; HA-1077 Impurity 13; AT877 Impurity; (1,5-Diazacyclohept-1-yl)-5-isoquinolinesulfonamide; 5-[(Hexahydro-1H-1,4-diazepin-1-yl)sulfonyl]isoquinoline; AT-877 Impurity 13
EINECS	Contact for details

Quality Control

Every batch of Fasudil Impurity 13 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The container should be kept in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.