Description

Fasudil Impurity 37 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Fasudil, a Rho-kinase inhibitor used in clinical research. It serves as an essential analytical marker for manufacturers and analytical laboratories engaged in method development, validation, and impurity profiling. Ensuring the integrity of your active pharmaceutical ingredient (API) requires reliable and well-characterized impurities like this one.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Fasudil API and related drug products.
• Impurity Profiling & Identification: Critical for identifying, monitoring, and controlling specified impurities during Fasudil manufacturing to meet ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC, LC-MS, or GC-MS methods.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure Fasudil batches conform to strict purity specifications.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Used as a marker to track degradation pathways and establish the shelf-life of Fasudil formulations.
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Fasudil Impurity 37
CAS No.	1314322-31-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fasudil Related Compound 37; HA-1077 Impurity 37; 5-Isoquinolinesulfonamide, 1-(5-isoquinolinylsulfonyl)hexahydro-; AT877 Impurity 37; (Hexahydro-1-(5-isoquinolinylsulfonyl)-1H-1,4-diazepin-5-isoquinolinesulfonamide); ERIL Impurity 37; Rho-kinase Inhibitor Impurity 37
EINECS	Contact for details

Quality Control

Every batch of Fasudil Impurity 37 is manufactured under a strict quality management system and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We adhere to ICH guidelines for impurity qualification, ensuring the material is fit for its intended use in regulatory filings and high-stakes analytical work.

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 prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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