Description

Fasudil Impurity 2 (Isoquinoline-8-Sulfonic Acid) is a high-purity chemical reference standard, identified by CAS NO 1352414-81-3, primarily used for analytical and research purposes in pharmaceutical development. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Fasudil, a Rho-kinase inhibitor. It is an essential tool for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity supports robust quality control protocols and accelerates drug development timelines.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference standard for the identification and quantification of a specific impurity in Fasudil API and its formulations.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Stability Indicating Method Studies: Employed to monitor the degradation pathways of Fasudil under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release Testing: Essential for in-house QC laboratories to ensure API batches meet stringent pharmacopeial or internal purity specifications.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research and Development: Used in academic and industrial R&D to study the metabolism, synthesis pathways, and chemical behavior of isoquinoline sulfonic acid derivatives.
• Calibration of Analytical Equipment: Acts a primary standard for calibrating instruments used in pharmaceutical analysis.

Basic Information

Product Name	Fasudil Impurity 2 (Isoquinoline-8-Sulfonic Acid)
CAS No.	1352414-81-3
Molecular Formula	C9H7NO3S
Molecular Weight	209.22 g/mol
Synonyms	8-Isoquinolinesulfonic Acid; Isoquinoline-8-sulfonic Acid; Fasudil Related Compound 2; HA-1077 Impurity 2; 1,5-Isoquinolinedisulfonic Acid (related isomer); 8-Sulfoisoquinoline; 1352414-81-3; AT 877 Impurity
EINECS	Contact for details

Quality Control

Every batch of Fasudil Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and Mass Spectrometry. We support compliance with ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider using desiccants.

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%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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