Description

Ripasudil Hydrochloride Dihydrate is a selective Rho-associated coiled-coil containing protein kinase (ROCK) inhibitor, supplied as a high-purity active pharmaceutical ingredient (API). This compound is critical for the development and manufacturing of ophthalmic therapeutics targeting elevated intraocular pressure. It is primarily required by pharmaceutical companies and research institutions engaged in the formulation of novel glaucoma treatments and related ophthalmic drug discovery.

Application

• Primary API for Glaucoma Medications: Core active ingredient in the formulation of topical ophthalmic solutions for the treatment of glaucoma and ocular hypertension.
• Pharmaceutical R&D: Used in preclinical and clinical research to study ROCK inhibition pathways and develop new therapeutic agents.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Drug Product Manufacturing: Integrated into Good Manufacturing Practice (GMP) processes for the commercial-scale production of finished dosage forms.
• Mechanistic Studies: Utilized in biochemical and pharmacological research to investigate the role of Rho-kinase in cellular signaling and disease pathology.

Basic Information

Product Name	Ripasudil Hydrochloride Dihydrate
CAS No.	887375-67-9
Molecular Formula	C₂₇H₃₂N₄O₄S • HCl • 2H₂O
Molecular Weight	563.11 g/mol
Synonyms	K-115; Ripasudil HCl Dihydrate; 4-Fluoro-5-[[(2S)-2-methyl-1,4-diazepan-1-yl]sulfonyl]isoquinoline Hydrochloride Dihydrate; (S)-4-Fluoro-5-(2-methyl-1,4-diazepane-1-sulfonyl)isoquinoline Hydrochloride Dihydrate; K115 Hydrochloride Dihydrate; GLANATEC (brand name API); SNJ-1656 (development code)
EINECS	Contact for details

Quality Control

Our Ripasudil Hydrochloride Dihydrate is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via validated methods such as HPLC and NMR. A Certificate of Analysis (COA) detailing all test results is provided to ensure traceability and compliance with relevant regulatory expectations for API sourcing.

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 conditions that minimize exposure to atmospheric humidity to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	5.0% - 7.0%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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