Description

Fasudil Impurity 12 CAS NO 1211517-62-2 is a high-purity chemical reference standard used for the analytical profiling and quality control of the pharmaceutical agent Fasudil. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Fasudil Impurity 12 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.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Fasudil batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to support the development of robust manufacturing processes.

Basic Information

Product Name	Fasudil Impurity 12
CAS No.	1211517-62-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fasudil Related Compound 12; 1-(5-Isoquinolinesulfonyl)homopiperazine Impurity 12; HA-1077 Impurity 12; AT877 Impurity 12; (E)-1-(5-Isoquinolinesulfonyl)homopiperazine; 1-[(E)-5-Isoquinolylsulfonyl]hexahydro-1H-1,4-diazepine; A potential isomer or degradation product of Fasudil.
EINECS	Contact for details

Quality Control

Our Fasudil Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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